GMP-Inspections of foreign veterinary manufacturers in the first half of 2021
This review contains the latest information related to inspection of manufacturers of veterinary medicinal products manufactured outside the Russian Federation for compliance with the requirements of the Good Manufacturing Practice (GMP). These inspections are conducted by specialists of the Federal State Budgetary Institution “The All-Russian State Center for Quality and Standardization of Veterinary Drugs and Feed” (FSBI “VGNKI”) subordinated to Rosselkhoznadzor.
Konstantin Morozov, GMP Specialist, Auditor of Pharmaceutical Enterprises
Since January 2021, the GMP Rules of the Eurasian Economic Union (EAEU GMP Rules), approved by the Resolution of the EEC Council No. 77 of November 3, 2016, entered into force with respect to medicinal products for veterinary use .
In January 2021, on the Official Internet Portal of Legal Information publication.pravo.gov.ruthe Order of Rosselkhoznadzor No. 1231 of November 17, 2020 “On approval of the application form for issuing a conclusion on the compliance for a manufacturer (foreign manufacturer) of veterinary medicinal products with the GMP Rules requirements, the form of the inspection report based on the results of the inspection of the manufacturer (foreign manufacturer) of veterinary medicinal products for compliance with the GMP Rules requirements and the form of the conclusion on the compliance of the manufacturer (foreign manufacturer) of veterinary medicinal products with the GMP Rules requirements” was published .
The approved document made changes to the form of the inspection report and the form of the conclusion on the compliance of the manufacturer of veterinary medicinal products with the GMP Rules requirements. In particular, in the form of the conclusion, the words “Rules of Good Manufacturing Practice, approved by order of the Ministry of Industry and Trade of the Russian Federation No. 916 of June 14, 2013” are replaced by the words “Rules of Good Manufacturing Practice of the Eurasian Economic Union, approved by the Resolution of the Council of the Eurasian Economic Commission Council No. 77 of November 3, 2016” .
In May 2021, the EEC Board approved a draft Resolution of the EEC Council on amendments to the EAEU GMP Rules .
According to the presented document, Annex 15 to the EAEU GMP Rules “Qualification and Validation” is presented in a new edition. The Resolution will enter into force 6 months after the date of its official publication .
The Annex establishes new, significantly expanded approaches to validation and qualification of manufacturing processes. For the first time, indications are introduced on the possibility of replacing validation with continuous process verification, ongoing process verification or verification (validation) of individual stages. Manufacturers will also be able to use a hybrid approach to validate the manufacturing process. As a result of the changes, the EAEU GMP Rules will be synchronized with the current European edition .
In April 2021, the EEC clarified that the provisions of the Commission’s acts concerning the order and procedure for conducting pharmaceutical inspections (Resolutions of the EEC Council of November 3, 2016 No. 82, 83, 90, 91) do not contain a corresponding clarification on the scope of application for veterinary medicinal products and therefore do not apply to their circulation. Considering that the draft Rules developed by the Commission, which provide for the order and procedure for conducting pharmaceutical inspections of the production of veterinary medicinal products, have not yet been adopted by the Commission, monitoring of compliance with the EAEU GMP Rules requirements in the production of veterinary medicinal products in the Member States of the Union is carried out in the manner established by the legislation of the corresponding Member State of the Union.
Thus, in relation to medicinal products for veterinary use, only the “Rules for organization and conduct of inspection of manufacturers of medicinal products for compliance with the GMP Rules requirements, as well as the issuance conclusions on the compliance of the manufacturer of medicinal products with the specified requirements”, approved by the Decree of the Government of the Russian Federation No. 1314 of December 03, 2015 “On determining the compliance of manufacturers of medicinal products with the GMP Rules requirements” apply .
In June 2021, within the framework of the business program of the exhibition “MVC: Cereals-Mixed Feed-Veterinary-2021”, the conference “Topical issues of circulation of veterinary medicinal products, prevention and treatment of infectious diseases of productive animals” was held. At this conference, Danil Rudniaev, Deputy Director, the Head of the Inspection Body of the FSBI “VGNKI” presented the topic “Four years of inspection of foreign manufacturers of veterinary medicinal products. Experience and Prospects”. Commenting on the results of inspections of foreign manufacturers in 2021, he noted that due to the ongoing pandemic, it is difficult to conduct on-site inspections and the queue of willing sites continues to grow. To date, it has been possible to carry out 14 inspections, of which only 4 were carried out with a visit to the manufacturing site .
In accordance with the inspection schedule published on the FSBI “VGNKI” website 05.07.2021, 50 inspections of manufacturers of veterinary medicinal products have already been planned for the second half of 2021 and for the first quarter of 2022, which sites located in Australia, Belarus, Belgium, Bulgaria, Brazil, Hungary, Vietnam, Germany, Egypt, Spain, Italy, China, Korea, the Netherlands, Slovenia, the USA, Turkey, Uruguay, Finland, France, Czech Republic and Switzerland .
According to the register of issued conclusions published on the Rosselkhoznadzor website 27.05.2021, in 2021, 5 conclusions on the compliance of foreign manufacturers with the GMP Rules requirements have already been issued .
Two of these conclusions were made for the site located in France, and three others were made for sites located in Belgium, Israel and Portugal.
In accordance with clause 7 (1). of the Decree of the Government of the Russian Federation No. 1314 of December 03, 2015, in conditions of the threat of the emergence, occurrence and liquidation of an emergency and (or) when there is a threat of the spread of a disease that poses a danger to others, diseases and injuries resulting from exposure to adverse chemical, biological, radiation factors, in which the inspection of the manufacturer, providing for an inspection of the manufacturing site is not possible, the conclusion issued for a period of 3 years, which is calculated from the date of completion of the inspection manufacturing site according to documents, including using remote interactions, including audio or video communication .
Speaking at the conference within the framework of the exhibition “MVC: Cereals-Mixed Feed-Veterinary-2021”, Danil Rudniaev said that in total 41 requests for remote inspections were received from foreign manufacturers of veterinary medicinal products to Rosselkhoznadzor, and in respect of 20 of them a positive decision was made (to date, 19 remote inspections have already been carried out and one inspection is scheduled for mid-July). Presenting the results of inspection of foreign manufacturers over the past year, he noted a drop in the number of inspections carried out, since due to the pandemic, the visit of inspectors to many sites did not take place. At the same time, Danil Rudniaev drew attention to the fact that it is impossible to inspect high-tech enterprises, especially those that produce immunobiological products, in a remote format .
Corrective and preventive actions (CAPA) on the results of inspection
In accordance with clause 27. of the Decree of the Government of the Russian Federation No. 1314 of December 03, 2015, the foreign manufacturer or its authorized representative may submit to the authorized institution within 60 working days of receipt of the inspection report (without completing the section containing the final recommendations and conclusions), a letter accompanied by the CAPA plan as well as copies of documents, drawn up in the prescribed manner, containing measures for its implementation, along with a document confirming payment for the additional inspection services .
In June 2021, on the Rosselkhoznadzor website in the section “Inspection. Issuance of a conclusion” a new “Form for filling out a plan of corrective and preventive actions to eliminate nonconformities identified during the inspection” was published .
Frequently repeated nonconformities
In May 2021, a conference was held in Suzdal on the topic “Pharmaceutical quality system. Topical issues of quality assurance of medicinal products”. This event was held as part of the third day of the industry press tour of the III All-Russian Pharmprobeg. Speaking at this conference, Danil Rudniaev noted that the first thing the inspectors encountered when they began to inspect manufacturers of veterinary medicinal products was a large number of nonconformities associated with discrepancies in information in the registration dossier and the actual state of affairs on the site. For example, the control methods that were prescribed in the registration dossier did not match the control methods used at the enterprise .
At the conference within the framework of the exhibition “MVC: Cereals-Mixed Feed-Veterinary-2021”, Danil Rudniaev presented a list of frequently repeated nonconformities when inspecting manufacturers of veterinary medicines:
change control is not carried out (the effectiveness of the changes made to the production process is not evaluated);
there is no incoming control of primary packaging materials for microbiological purity (in particular, for non-sterile products);
test samples are not representative of the batch of material or finished product from which they are selected (tools are used with which it is not possible to select a representative sample from large-volume raw material containers);
qualification of warehouses is carried out without taking into account the risk of temperature fluctuations during the change of seasons (tests are not carried out during the hottest and coldest period of the year for a particular region);
the quality control methods used at the enterprise are not validated (methods are not validated for specific premises and specific site equipment);
stages of qualification of the performance or operation of premises, systems and equipment does not include the necessary elements (IQ, OQ, PQ);
process validation does not perform tests at operating parameters equal to the upper and lower allowable limits;
process validation (including cleaning validation) did not include 3 successive consecutive batches (cycles), at which the parameters were within the established limits;
the intervals between use and cleaning as well as cleaning and reuse are not determined (the same for sterilization);
the integrity control of vials with sterile products is not carried out (control is not carried out with the frequency determined taking into account the risk analysis);
the primary containers of parenteral products are not checked for foreign matter (100% control of all units is not carried out) .
Agreeing of the timeframes for elimination of critical nonconformities
In May 2021, on the Official Internet Portal of Legal Information publication.pravo.gov.ruthe Order of Rosselkhoznadzor No. 282 of March 22, 2021 “On the establishment of the procedure for the suspension of the sale and use of medicinal products for veterinary use” was published .
According to the approved document, one of grounds for consideration by Rosselkhoznadzor of the issue of suspending the sale and use of a medicinal product for veterinary use is the following case: the manufacturer of medicinal products, in a time agreed with Rosselkhoznadzor, has not eliminated violations of the GMP Rules requirements that were identified during the inspection of the manufacturer of medicinal products and that have led or may lead to production medicinal products that have caused or are likely to harm to life or health of animals .
In June 2021, in order to discuss issues related to the entry into force of the Order of Rosselkhoznadzor No. 282 of March 22, 2021, the Directorate for Domestic Veterinary Surveillance of Rosselkhoznadzor held a video conference with the participation of representatives of the veterinary and pharmaceutical business communities. Based on the results of the agreements reached at this meeting, on the Rosselkhoznadzor website, in the section “Pharmacovigilance”, “Recommendations for agreeing with Rosselkhoznadzor a plan of corrective and preventive actions to eliminate nonconformities identified during the inspection. Form for filling out a plan of corrective and preventive actions to eliminate nonconformities identified during the inspection” were published .
GMP-conclusion when putting medicines into civil circulation
In June 2021, at a plenary session of the State Duma of the Federal Assembly of the Russian Federation, a draft Federal Law “On amendments to the Federal Law “On circulation of medicines” on the issue of putting veterinary medicinal products into civil circulation” was adopted in the third reading. The adopted Federal Law No. 317-FZ of July 02, 2021 was published on the Official Internet Portal of Legal Information publication.pravo.gov.ru .
The Law stipulates that the entering into civil circulation of a medicinal product for veterinary use imported (transferred) to the Russian Federation is carried out if there is a conclusion on the compliance of the manufacturer of medicinal products with the GMP Rules requirements, which was issued by the authorized federal executive body for the manufacturing site of the medicinal product for veterinary use entering into civil circulation. The Federal Law will enter into force on September 1, 2023 .
In April 2021, the grand opening of the Eurasian Academy of Good Practices took place at the Chamber of Commerce and Industry of the Russian Federation, where both pharmaceutical inspectorates from different countries and specialized industry representatives will be trained. The opening ceremony was attended by the top officials of the relevant ministries and departments of the EAEU Member States, the EEC, representatives of the regulatory bodies of the union states, industry communities and associations, as well as heads of pharmaceutical companies. The Academy is a subsidiary the Federal State Institution “State Institute of Drugs and Good Practices” (FSI “SID & GP”) .
Speaking at the opening ceremony, Leonid Kish, Director of the FSBI “VGNKI”, noted that the creation of the Academy of Good Practices is a serious event not only in the field of advanced training of pharmaceutical inspectors but also in the preparation of new highly qualified specialists in the pharmaceutical industry .
At the conference within the framework of the III All-Russian Pharmprobeg, Vasilina Gritsyuk, Deputy Director of the FSBI “VGNKI” drew particular attention to the fact that even if there is a certain set of knowledge, it is extremely important to constantly improve qualifications .
In 2021, FSBI “VGNKI” continues to conduct training events for specialists of enterprises-manufacturers of veterinary medicines .
In the first half of 2021, as part of a joint program of promoting implementation of the best practices in the Russian pharmaceutical industry – the “SOLIDARY TRAINING PROGRAM” project, more than 20 corporate seminars were held for companies with an “open-door policy”. The project was initiated by the “PHARMSTRATEGY” company and FSI “SID & GP” .
In June 2021, registration was opened for the VI All Russia GMP Conference with international participation, which will be held in St. Petersburg on September 22-24. The organizer of the conference is the Ministry of Industry and Trade of Russia together with the FSI “SID & GP”. On September 23, within the framework of the conference, a panel discussion “Inspection of manufacturers of veterinary medicines. Regulation and statistics. The view of the state and business” will be held. Among the issues planned for the discussion: regulation of inspection of manufacturers of veterinary medicines under EAEU Rules; experience of inspecting European manufacturers of veterinary medicines. Among the speakers who are planning to speak are representatives of the FSBI “VGNKI”, the Ministry of Agriculture of Russia, Rosselkhoznadzor, the EEC, veterinary medicines manufacturing companies .
Manufacturers of veterinary medicines are encouraged to take an active part in training events and prepare more thoroughly for GMP inspections.
The material presented was prepared using data relevant to 21.07.2021. In case of new or additional data, the article can be updated.
Официальный интернет-портал правовой информации / Приказ Федеральной службы по ветеринарному и фитосанитарному надзору от 17.11.2020 № 1231 «О внесении изменений в приказ Россельхознадзора от 18 октября 2016 г. № 755 «Об утверждении формы заявления о выдаче заключения о соответствии производителя (иностранного производителя) лекарственных средств для ветеринарного применения требованиям правил надлежащей производственной практики, формы инспекционного отчета по результатам инспектирования производителя (иностранного производителя) лекарственных средств для ветеринарного применения на соответствие требованиям правил надлежащей производственной практики и формы заключения о соответствии производителя (иностранного производителя) лекарственных средств для ветеринарного применения требованиям правил надлежащей производственной практики». URL: http://publication.pravo.gov.ru/Document/View/0001202101180011 (дата обращения 15.07.2021)
Евразийский экономический союз / Распоряжение Коллегии Евразийской экономической комиссии от 19.05.2021 г. № 77 «О проекте Решения Совета Евразийской экономической комиссии «О внесении изменений в Правила надлежащей производственной практики Евразийского экономического союза». URL: https://docs.eaeunion.org/docs/ru-ru/01429302/err_24052021_77 (дата обращения 15.07.2021)
ФГБУ «ВГНКИ» / Структура / Отдел инспекции производства на соответствие требованиям надлежащей производственной практики / Нормативно-правовая документация. URL: http://www.vgnki.ru/assets/files/post-1314.pdf (дата обращения 15.07.2021)
ФГБУ «ВГНКИ» / Структура / Отдел инспекции производства на соответствие требованиям надлежащей производственной практики / График проведения инспектирования иностранных производителей на соответствие требованиям надлежащей производственной практики. URL: http://www.vgnki.ru/assets/files/grafik-na-sajt- pdf (дата обращения 05.07.2021)
Россельхознадзор / Регистрация и лицензирование / Инспектирование. Выдача заключения / Форма заполнения плана корректирующих и предупреждающих действий по устранению несоответствий, выявленных в ходе инспектирования. URL: https://fsvps.gov.ru/fsvps/regLicensing/conclusion (дата обращения 07.2021)
Россельхознадзор / Регистрация и лицензирование / Фармаконадзор / Рекомендации по согласованию с Россельхознадзором сроков по устранению несоответствий, выявленных при проведении инспектирования/лицензионного контроля. Форма заполнения плана корректирующих и предупреждающих действий по устранению несоответствий, выявленных в ходе инспектирования/лицензионного контроля. URL: https://fsvps.gov.ru/fsvps/regLicensing/farmakonadzor.html (дата обращения 15.07.2021)
Евразийская Академия надлежащих практик / Новости / Открытие GxP Академии объединило регуляторов стран ЕАЭС. URL: https://gxp-academy.org/news/otkrytie-gxp-akademii-obedinilo-regulyatorov-stran-eaes/ (дата обращения 15.07.2021)
ФГБУ «ВГНКИ» / Образование / Дополнительное профессиональное образование / Планы мероприятий / План обучающих мероприятий для специалистов предприятий-производителей лекарственных средств для ветеринарного применения на 2021 год. URL: http://www.vgnki.ru/assets/files/plan-2021-itog_proizvoditeli.pdf (дата обращения 15.07.2021)
Совместная программа содействия внедрению лучших образцов надлежащих практик в российской фармацевтической отрасли / Отчеты / Календарно-тематический план «Солидарной программы обучения» (январь-июнь 2021 г.). URL: https://www.goodpractices.ru/upload/iblock/ca6/SP-i-SORpdf (дата обращения 15.07.2021)
VI Всероссийская GMP-конференция с международным участием. URL: http://gosgmp.ru/ (дата обращения 21.07.2021)
This Combination Vaccine May Simplify Execution and Reduce Shots Needed to Complete CDC’s Recommended Child and Adolescent Immunization Schedule VAXELIS™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine), developed as part of a U.S.-based partnership between Merck, known as MSD outside the United States and Canada, and Sanofi Pasteur, the global vaccines business unit of Sanofi, is now available in the U.S. VAXELIS is the first and only hexavalent (six-in-one) combination vaccine available in the U.S. indicated for active immunization to help prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday). Given the potential to reduce the number of shots by as many as three in the first six months of life, as compared to pentavalent vaccines plus hepatitis B or Haemophilus influenzae type b vaccines, VAXELIS represents an important option for healthcare professionals and parents, – said Joanne Monahan, senior vice president, U.S. Vaccines, Merck. – Merck and Sanofi have been in contact with the major insurers and the appropriate pricing […]
Bayer is building a new pharmaceutical facility in Turku and at the same time modernizing its existing production plant. The new production facility will use the latest technology and utilize automation and robotics extensively. The value of the total investment is €250 million, which is one of the largest investments in Finland in recent years. The investment will further strengthen Bayer’s footprint in Finland and Turku’s position as the contraceptive capital of the world. This investment is significant for both Bayer and Finland. It secures long-term supply, which is required to meet Bayer’s global sustainability goals. One of these goals is to provide 100 million women in low-and middle-income countries with access to family planning and modern contraception by the end of 2030. Turku plays a significant role in Bayer’s global sustainability strategy which is in line with the UN Sustainable Development Goals. The investment will further promote the measures that our Turku plant has already taken over the past 30 years, to achieve gender equality and support women and their families. This way we can make an impact on women’s health and social status, education and family size, – says Miriam Holstein, CEO of Bayer Nordic Bayer’s global sustainability […]
The European Investment Bank (EIB) and Univercells S.A (Univercells) have signed a €30 million loan agreement to enable the production of large volumes of prophylactic COVID-19 vaccines in a new facility and to co-develop a pipeline of COVID-19 vaccines. This facility will address the unprecedented global demand for vaccines brought on by the COVID-19 pandemic. The partnership backs Univercells’s Belgian hub, strengthening pandemic resilience in Europe and supporting global manufacturing autonomy through Univercells’ efforts to launching new production sites around the world based on the company’s innovative biomanufacturing technology. In collaboration with the European Commission, the EIB Group is on its way to mobilising billions for the COVID-19 response, which it kicked off as soon as the crisis hit to tackle the global health emergency and the economic consequences of the COVID-19 pandemic. The InnovFin Infectious Diseases Finance Facility (IDFF) was scaled up at the beginning of the outbreak to directly support highly innovative projects that work towards halting the spread of the virus. The programme helps biotech and medtech companies across Europe find solutions for vaccines, cures and diagnostics. The new venture debt to Univercells backed by the IDFF adds to a previous €20 million operation under the programme […]
The European Medicines Agency (EMA) announced on June 11, 2021 that its committee for human medicines (CHMP) has approved a new manufacturing site for the production of Moderna COVID-19 vaccine finished product. The site, operated by Recipharm, is located in Monts, France. In addition to the new manufacturing facility for this vaccine, the CHMP has also given a positive opinion for the addition of several alternative sites responsible for batch control/testing. Already on 4 June 2021, two new sites for the manufacturing of active substance and finished product intermediates, located in the US (ModernaTX, Inc., Norwood, Massachusetts and Lonza Biologics, Inc., Portsmouth, New Hampshire), were approved by CHMP. Together, these changes are expected to allow the production of an additional one to two million vials of ready-to-use vaccine for the European Union market every month. This will increase the supply of the vaccine in the European Union. This recommendation does not require a European Commission decision and the site in Monts can become operational immediately. The changes described will be included in the publicly available information on this vaccine.
Parliament wants to strengthen the transparency of both the Agency and all actors in the supply chain, and give a more active role to healthcare professionals, as well as encouraging synergies between EU agencies.
Scientists claim the nanoparticles obtained can carry an increased antibiotic “load” and easily penetrate tissues from the bloodstream and back, ensuring continuous drug delivery to the site of infection.
For the first quarter of 2021 NPO Microgen, managed by the Nacimbio holding of the Rostec State Corporation, has increased the export of medicinal products to Uzbekistan by more than one and a half times compared to the same period last year. By volume, about 500 thousand packages of medicines have been exported to the republic. The medicines of the pharmacological group of bacteriophages, registered in the country in 2019, turned to be the key sales driver. Their ratio was about 40% of total sales. Sextafag, supplied to Uzbekistan since 2018, was in the highest demand. In the first quarter of this year alone, its sales to the republic exceeded the total annual sales volume of the drug in 2020 by 60%. Sextafag has a broad spectrum of antimicrobial action and is designed for the treatment and prevention of pyoinflammatory and enteric diseases caused by staphylococci, streptococci, Proteus mirabilis, Klebsiella, Pseudomonas, and E. coli. Moreover, wholesale supplies to the republic of two types of bacteriophages (Intesti and Staphylococcus bacteriophage) were arranged for the first time. For the Staphylococcus bacteriophage a new, more convenient dosage form of 20 ml was registered in Uzbekistan last year. The Republic of Uzbekistan is Microgen’s […]
The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) and Panacea Biotec, one of the leading vaccine and pharmaceutical producers in India, today announced the launch of production of the Russian Sputnik V vaccine against coronavirus. The first batch produced at Panacea Biotec’s facilities at Baddi will be shipped to the Gamaleya Center for quality control. Full-scale production of the vaccine is due to start this summer. Company’s facilities comply with GMP standards and are prequalified by WHO. Sputnik V was registered in India under the emergency use authorization procedure on April 12, 2021 and vaccination against coronavirus with the Russian vaccine started on May 14. As announced in April, RDIF and Panacea have agreed to produce 100 million doses per year of Sputnik V. To date Sputnik V has been registered in 66 countries globally with total population of over 3.2 billion people. Efficacy of Sputnik V is 97.6% based on the analysis of data on coronavirus infection rate among those in Russia vaccinated with both components of Sputnik V from December 5, 2020 to March 31, 2021. The vaccine is based on a proven and well-studied platform of human adenoviral vectors and uses two different vectors for […]
Russia has put into circulation about 32 million sets of coronavirus vaccines since the beginning of the year, and new sites are joining in the production effort to ensure vaccination, the Industry and Trade Ministry told TASS. “All the four national vaccines are produced rhythmically in line with the plans drawn up together with the manufacturers. The difference in their time availability is caused by different times of their registration, namely August 2020 (Sputnik V), October 2020 (EpiVacCorona), February 2021 (CoviVac) and May 2021 (Sputnik Light),” the Industry and Trade Ministry said. Since the beginning of the year, more than 30 million sets of Sputnik V, nearly 1.5 million [sets] of EpiVacCorona and 352,000 [sets] of CoviVac, which was registered later than the first two vaccines, have been put into circulation,” the ministry said noting that the difference in the vaccines’ availability was caused by different timeframes of their authorization. The press service explained that from the stage of authorization to large-scale production, each vaccine had to undergo a series of steps related to the scaling up of technology and quality control of the vaccines. “New production sites are joining in the production of each of the vaccines to ensure […]
An application for the registration of the anti-COVID vaccine EpiVacCorona-N has been submitted to the Russian Health Ministry for registration, as follows from a post uploaded to the state register of medicines. Earlier, the CEO of the State Research Center of Virology and Biotechnology Vector, Rinat Maksyutov, said there were no fundamental distinctions between EpiVacCorona-N and the previous version EpiVacCorona. EpiVacCorona, developed at the State Research Center of Virology and Biotechnology Vector, was a second vaccine to have been registered in Russia. The registration certificate was issued on October 14, 2020. About a month later the vaccine’s developers were given permission to conduct post-registration research in different groups of patients, including elderly people.
The Russian Health Ministry has issued a permit to conduct the post-registration clinical trials of the CoviVac shot against the coronavirus infection with the participation of 32,000 volunteers. The corresponding information was published on the website of the state register of clinical trial permits of the Russian Health Ministry on Tuesday. (TASS) “An open comparative study of the preventive efficacy and a non-comparative study of the immunogenicity and safety of the CoviVac preparation (a whole-virion inactivated concentrated purified coronavirus vaccine), produced by the Federal State Budgetary Scientific Institution Chumakov Federal Scientific Center for Research and Development of Immune and Biological Products of the Russian Academy of Sciences on healthy volunteers aged 18-60. The beginning of the trials kicked off on June 2, 2021, and will end on December 30, 2022. The number of patients amounts to 32,000,” – according to the information posted on the website. The register also indicates that the trials will be held on the basis of 16 medical organizations in Kirov, St. Petersburg, Moscow, Obninsk, Chelyabinsk, Tatarstan, Zheleznogorsk, Stary Oskol, and Novotroitsk. On February 19, the Russian Healthcare Ministry certified the whole-virion inactivated CoviVac vaccine, developed by the Chumakov Federal Scientific Center for Research and Development […]
Interleukin-6 blocking drugs – tocilizumab and sarilumab – act to suppress this overreaction. WHO has launched an expression of interest for prequalification of manufacturers of interleukin-6 receptor blockers.
Etten-Leur, Tokyo, Moscow, June 9, 2021. R-Pharm Group announces the signing of a distribution agreement with PHC Europe B.V., one of the largest suppliers of biopharmaceutical and medical equipment, formerly known as Panasonic Biomedical Sales Europe B.V.. The agreement provides for R-Pharm to register and promote in Russia, Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Uzbekistan and Ukraine its high-tech refrigeration equipment, biotech incubators, climate chambers and an entire line of equipment for laboratories, biotech facilities, and medical institutions. PHCbi refrigeration equipment covers a temperature range from +23 to -150 ℃, making it possible to store all known types of vaccines and biologics, as well as blood and its components. It is important to note that the PHC refrigeration equipment is designed not only for medical institutions, but also for research laboratories and biopharmaceutical production. As of today, R-Pharm’s production sites have already purchased more than 20 units of equipment to support the vaccine project. Denis Cherednichenko, Vice-President for Medical Systems at R-Pharm Group: We welcome the agreement between R-Pharm and PHC Europe B.V. coming into force. It represents an important milestone in the development of the strategic partnership between Russia and Japan. Regarding the organization of this cooperation, […]
Governments around the world struggle with the logistical challenges of procuring, deploying and administering vaccines at scale. To deliver the vaccines, pharmaceutical companies, logistical partners and governments have come together to create a “cold chain” that ensures vaccines are kept at precise temperatures—adding a major layer of complexity to the delivery of vaccines. The Role of Good Distribution Practices Clearly there’s still much that can be done from a logistical standpoint to ensure the various vaccines are able to reach the people who need them. Complexity and challenges can be found throughout the vaccine cold chain, but one major factor working in our favor is the emergence of new technology and infrastructure that will help ensure the integrity of the vaccine cold chain. Good Distribution Practices (GDP) that describe calibration of all temperature measurement instruments and storage devices are moving from recommendations to requirement—and the quicker they’re adopted and integrated into vaccine logistics globally, the sooner the promise of vaccine prevention could help end the pandemic. GDP was created in U.S. by the FDA, but at present they’re only recommendations and not requirements. Unfortunately, during the pandemic little progress has been made in implementing them more fully, but if they had […]
CureVac shares fell by as much as 52% on Thursday after the German biotech’s COVID-19 vaccine proved only 47% effective in an initial trial, denting investor confidence in its ability to take on established rivals, reports Reuters . The disappointing efficacy of the shot known as CVnCoV emerged from an interim analysis in a study of about 40,000 volunteers in Europe and Latin America, with CureVac saying on Wednesday that new variants had proved a headwind. Late-stage trials of BioNTech/Pfizer and Moderna vaccines, which like CureVac’s are based on mRNA technology, had efficacy rates of well above 90% but took place when the original version of the coronavirus was dominant. Data on their products have, however, so far suggested only somewhat weaker protection against new variants. “This could cast doubt on competitiveness of its mRNA platform,” Jefferies said in a research note on CureVac’s study. CureVac shares were down 44% at 1005 GMT in Germany, trading at their lowest in more than seven months and wiping more than 6 billion euros off the company’s market value. Public health representatives across the globe are pushing for a fast deployment of available vaccines to counter highly contagious mutations of COVID-19 such as […]
Isotope JSC (a part of Rusatom Healthcare JSC, Rosatom’s radiation technologies integrator) has signed a five-year contract with Brazil’s Nuclear and Energy Research Institute (IPEN; linked to the National Nuclear Energy Commission or CNEN) to supply lutetium-177 and actinium-225, the most promising medical isotopes in radiopharma. A long-term contract for monthly supplies of 177Lu-trichloride carrier-added became possible following a successful registration of lutetium-177 manufactured by INM JSC and approval of the Russian-made radioisotope for further registration of radiopharmaceutical DOT-IPEN-177 produced by IPEN/CNEN by the Brazilian National Health Surveillance Agency (Anvisa). The contract strengthens ROSATOM’s standing as the leading supplier of radioisotopes to the Latin American markets. This contract is the result of many years of meticulous work on both sides. It is of great social importance as it opens up new possibilities for the treatment of thousands of patients. With its unique technological base of research reactors, ROSATOM State Corporation produces the widest range of medical isotopes. One of the key tasks of Rusatom Healthcare and Isotope JSC is to increase the availability of radionuclide products which are the foundation of Nuclear Medicine. Collaboration with IPEN-CNEN is an example of international cooperation aimed to introduce high technologies to cancer treatment […]
TriRx Pharmaceutical Services Inc., a leading international CDMO, today announced an agreement to acquire two facilities from Elanco Animal Health Incorporated. Elanco is a global animal health leader dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets. The sites are located in Shawnee, Kansas and Speke, United Kingdom, and will expand the manufacturing footprint of TriRx, adding to its existing pharmaceutical facilities in Huntsville, Alabama, and Segré, France. The sale of the Shawnee and Speke sites includes the physical assets at both locations and the transfer of approximately 600 employees. The two companies have also entered into long-term supply agreements for both facilities to continue to manufacture existing Elanco products. We are excited about this opportunity, taking us into a long-term partnership with Elanco, and welcome the employees at both Speke and Shawnee into our organization, – said Tim Tyson, Chairman and CEO at TriRx. – We have been impressed with the high caliber of people and capabilities at both sites and we look forward to acquiring additional customers at the sites to increase efficiency and utilization and to assure a long-term success. Jeff Simmons, President and CEO at Elanco Animal […]
This article provides information on French manufacturers of veterinary medicines and the French Agency for Veterinary Medicinal Products (ANMV). In addition, the article summarizes the results of an inspection of French manufacturers for compliance with the requirements of the Good Manufacturing Practice (GMP), which were conducted in 2017-2020 by specialists of the Federal State Budgetary Institution “The All-Russian State Center for Quality and Standardization of Veterinary Drugs and Feed” (FSBI “VGNKI”) subordinated to Rosselkhoznadzor. French manufacturers of medicines for animals According to the French Association for Animal Health Industry (SIMV), France is the European leader in research and manufacture of veterinary medicines and reagents, with over 6,700 employees, and the largest therapeutic arsenal in Europe (2,700 marketing authorizations). Furthermore, two in every three medicines produced in France are exported . France offers products and services for the prevention and treatment of diseases affecting farm animals (cattle, pigs, sheep, poultry), pets (dogs, cats, horses), and wildlife (foxes, raccoons). In addition, veterinary autogenous vaccines are produced in France. Autogenous vaccine is a vaccine prepared using microorganisms which have been isolated from the same infected animal to which it is then administered. Autogenous vaccines regulation is defined in the Public Health Code and […]
ISPE announced the release of its latest Guide, ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry. The Guide focuses on how Knowledge Management (KM) can enable a more effective Pharmaceutical Quality System (PQS).
Vietnamese Prime Minister Pham Minh Chin has requested accelerating the transfer of vaccine production technology and the testing and production of home-grown vaccine for COVID-19, so that Vietnam will be able to produce COVID-19 vaccines no later than June 2022. The Company for Vaccine and Biological Production No.1 (Vabiotech) – the biggest vaccine manufacturer and supplier for the EPI in Vietnam is in talks with Russia to produce Sputnik V vaccine in the country. He made the order during working sessions with several producers of vaccines, biological products and medical supplies in Hanoi on June 24. At the Vaccine and Biological Production Company No. 1 under the National Institute of Hygiene and Epidemiology, the PM also reiterated the need to carry out the vaccination campaign in the quickest, most effective and safest manner. (VietnamPlus, Vietnam News Agency) During a working session with Medicon company which specialises in producing test kits for medical needs, the PM asked the company to keep up its creative spirit in research and production of medical products, including medical supplies for COVID-19 prevention and control. Successful realization of the vaccine strategy is the top solution to prevent and push back the COVID-19 pandemic as Vietnam, one […]
AstraZeneca has entered into a collaboration with Regeneron to research, develop and commercialise small molecule compounds directed against the GPR75 target with the potential to treat obesity and related co-morbidities. The companies will evenly split research and development costs and share equally in any future potential profits. As published in Science, the new target was found by sequencing nearly 650,000 people and identifying individuals with rare protective mutations. Individuals with at least one inactive copy of the GPR75 gene had lower body mass index (BMI) and, on average, tended to weigh about 12 pounds less and faced a 54% lower risk of obesity than those without the mutation.1 Strong associations were also seen with improvements in diabetes parameters, including glucose lowering.1 Obesity and insulin resistance are key drivers in the development of type-2 diabetes and often lead to cardiorenal complications, as well as liver disease. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: We are pleased to announce this important collaboration with Regeneron to identify small molecule modulators against GPR75, a newly identified target with genetic validation in metabolic disorders. Obesity and insulin resistance remain key drivers in the development of type-2 diabetes and areas of significant unmet medical […]
The Heads of the World Bank Group, International Monetary Fund, World Health Organization, and World Trade Organization today convened for the first meeting of the Task Force on COVID-19 Vaccines, Therapeutics and Diagnostics for Developing Countries. They issued the following joint statement: “As many countries are struggling with new variants and a third wave of COVID-19 infections, accelerating access to vaccines becomes even more critical to ending the pandemic everywhere and achieving broad-based growth. We are deeply concerned about the limited vaccines, therapeutics, diagnostics, and support for deliveries available to developing countries. Urgent action is needed now to arrest the rising human toll due to the pandemic, and to halt further divergence in the economic recovery between advanced economies and the rest. We have formed a Task Force, as a “war room” to help track, coordinate and advance delivery of COVID-19 health tools to developing countries and to mobilize relevant stakeholders and national leaders to remove critical roadblocks—in support of the priorities set out by World Bank Group, IMF, WHO, and WTO including in the joint statements of June 1 and June 3, and in the IMF staff’s $50 billion proposal. At today’s first meeting, we discussed the urgency of increasing supplies of vaccines, […]
There are currently 59 Ph. Eur. texts – covering a variety of topics including vaccines for human use, blood products, antibiotics, radiopharmaceuticals and containers – that refer to the RPT and will be affected.
It is envisaged to implement the project in three stages from 2021 to 2024, the amount of investment from the company “SOLYPHAR” will be more than 20 million US dollars, in accordance to the international GMP standards.
The U.S. Food and Drug Administration has approved Pfizer Inc.’s (PFE) PREVNAR 20 or Pneumococcal 20-valent Conjugate Vaccine for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae or pneumococcus serotypes in the vaccine in adults ages 18 years and older.
The Directors-General of the World Health Organization (WHO), the World Intellectual Property Organization (WIPO) and the WTO agreed to enhance their support to members battling COVID-19 by collaborating on a series of workshops to augment the flow of information on the pandemic and by implementing a joint platform for tripartite technical assistance to member governments relating to their needs for medical technologies. As a result of their meeting on 15 June, Dr Tedros Adhanom Ghebreyesus, Daren Tang and Dr Ngozi Okonjo-Iweala issued a joint statement. On June 15, 2021, we, the Directors General of WHO, WIPO and the WTO, met in a spirit of cooperation and solidarity to map out further collaboration to tackle the COVID-19 pandemic and the pressing global challenges at the intersection of public health, intellectual property and trade. Acutely conscious of our shared responsibility to communities across the world as they confront a health crisis of unprecedented severity and scale, we pledged to bring the full extent of the expertise and resources of our respective institutions to bear in ending the COVID-19 pandemic and improving the health and well-being of all people, everywhere around the globe. We underscored our commitment to universal, equitable access to COVID-19 […]
American Gene Technologies (AGT), a clinical-stage biotechnology company, announced treatment of the first participant in its Phase I clinical trial to evaluate safety of the cell and gene therapy product AGT103-T. Designated as the RePAIR trial (Restore Potent Antiviral Immune Responses, NCT04561258), participants are infused once with their own CD4 T cells that were enriched, for cells capable of reacting to HIV, and genetically modified to resist infection. The first infusion took place at Washington Health Institute, Washington, D.C. on May 19. This is a first-in-human study for AGT103-T. The primary endpoint is safety; testing related to secondary endpoints evaluates responses to treatment including changes in the immune response to HIV. Participants treated with AGT103-T will be followed for 6 months in this safety study before enrolling in an FDA-mandated 15-year long-term follow up required for all gene therapy trials. Enrollment, product manufacturing, and treatments are ongoing at AGT’s clinical trial sites. “Treating the first person with our product is an important step forward and the culmination of design, development, manufacturing, and approval of the product for human testing. We believe this therapy is capable of changing the body’s ability to fight HIV and the first-in-man study signals the first […]
A Russian military research unit that was involved in the development of Sputnik V is working on a new coronavirus vaccine in the form of chewing gum, the RBC news website reported Friday. The Defense Ministry’s 48th Central Research Institute collaborated with the state-run Gamaleya Research Institute in Moscow to develop and trial Sputnik V last year. Russia, facing accusations of rushing human trials, touted the adenoviral vector vaccine as the world’s first to be approved for widespread use. Citing an unnamed Defense Ministry source and confirmation from the 48th Central Research Institute’s director, RBC said “work is underway” toward developing a mucosal Covid-19 vaccine in the form of chewable tablets and pastilles. “After testing, the drug will be included in various treatment and prevention regimens for coronavirus,” the source was quoted as saying. Col. Sergei Borisevich, who heads the 48th Central Research Institute, confirmed work on the new vaccine but did not specify what stage it was at. Russia has registered a total of four coronavirus vaccines and has reached agreements with close to 70 countries on selling Sputnik V or sharing the technology to manufacture it. Moscow’s active efforts to market the two-shot vaccine around the world has been viewed […]
China has provided more than 480 million doses of COVID-19 vaccines to the world, a Chinese Foreign Ministry spokesperson said here Friday. Wang Wenbin said China is a firm believer in making COVID-19 vaccines a public good, and has provided the most vaccines to the world. He said China so far has provided vaccines to nearly 100 countries, and announced that it has pledged to provide the first batch of 10 million doses of vaccines to COVAX. Chinese vaccines are the first batch of vaccines obtained by many developing countries. China has carried out joint research and development and cooperative production with many developing countries, and supported relevant companies to cooperate with foreign parties in conducting the phase III clinical trials, Wang said. He said the Chinese vaccines have gained a good reputation in the international community, adding that the safety and effectiveness of Chinese vaccines have been widely recognized. “At present, more than 100 countries have approved the use of Chinese vaccines. The WHO has included China’s Sinopharm and Sinovac vaccines in the emergency use list,” Wang said, adding that more than 30 foreign leaders took the lead in taking Chinese vaccines. Pledging that China will continue to contribute […]
Russian pharmaceutical company NovaMedica (part of the RUSNANO portfolio) and the corporation Bayer signed an agreement to provide Bayer with an exclusive license to commercialization of an innovative product developed by NovaMedica, including its manufacturing and promotion. The product in question is used for the treatment of proctologic diseases and has been developed as part of NovaMedica’s own R&D program. Bayer intends to commercialize it under the trade name Reliefipin. The product is a combination of two active ingredients with a therapeutic and pain relieving effect and will be manufactured in the form of topical water-based gel, which ensures effectiveness and convenience in the treatment of such diseases. In developing the product, NovaMedica used technologies that allowed combining previously incompatible active ingredients in one form, while improving their physical and chemical properties manifold. The formulation is patent-protected. Reliefipin will be available at Russian pharmacies as early as this June. The parties do not disclose financial details of the deal. Elena Litvinova, CEO, NovaMedica: “We are building our R&D program with a view to find out-of-the-box solutions to meet the current needs of patients. This is our focus. The fact that Bayer showed interest in our product means recognition of NovaMedica’s […]
The acquisition includes Teneobio’s proprietary bispecific and multispecific antibody technologies, which will enable significant acceleration and efficiency in the discovery and development of new molecules.
The 67,000-square-foot facility, located on Thermo Fisher’s Carlsbad campus, is part of an investment strategy to ensure customers can reliably meet growing global demand for cell and gene therapies and vaccines.
When an epidemic of smallpox came to the English village of Yetminster in 1774, Benjamin Jesty vaccinated his family with cowpox, and later Peter Plett repeated this experiment. The first known vaccines were developed in 1796, when Edward Jenner after finding a case of cowpox in a dairy maid collected matter from her pustules and inoculated an 8-year-old boy. In the 1870-80s, Louis Pasteur developed the first vaccines for anthrax and rabies. Autogenous vaccine (prepared from the bacteria harbored by the patient) was first introduced by Sir Almroth Edward Wright in 1903. In the following years, several case reports were published regarding the preparation and indications of autogenous vaccines. This article is dedicated to veterinary autogenous vaccines used to treat various animal infections. Important role of veterinary autogenous vaccines Today, autogenous vaccines play a much more important role than simply “filling the gap” where there are no commercial products currently available. They play a vital role in preventative health management programs, allowing veterinarians to stay close to the farm, better understand the existing disease status and as a result reduce the need for emergency treatments. This is particularly vital to ensure that antibiotics remain effective and available for use when […]
The World Health Organization (WHO) and its COVAX partners are working with a South African consortium comprising Biovac, Afrigen Biologics and Vaccines, a network of universities and the Africa Centres for Disease Control and Prevention (CDC) to establish its first COVID mRNA vaccine technology transfer hub. The move follows WHO’s global call for Expression of Interest (EOI) on 16 April 2021 to establish COVID mRNA vaccine technology transfer hubs to scale up production and access to COVID vaccines. Over the coming weeks, the partners will negotiate details with the Government of South Africa and public and private partners inside the country and from around the world. South African President Cyril Ramaphosa said: “The COVID-19 pandemic has revealed the full extent of the vaccine gap between developed and developing economies, and how that gap can severely undermine global health security. This landmark initiative is a major advance in the international effort to build vaccine development and manufacturing capacity that will put Africa on a path to self determination. South Africa welcomes the opportunity to host a vaccine technology transfer hub and to build on the capacity and expertise that already exists on the continent to contribute to this effort.” This is great news, particularly for […]
VTB Capital has invested in the pharmaceutical holding company Binnopharm Group. Sistema’s wholly-owned subsidiary LLC Sistema Telecom Assets sold an 11.2% stake in Ristango Holding Limited, which owns 100% of the authorised capital of Binnopharm Group, to Nevsky Property Investments Limited (controlled by VTB Capital). The transaction totalled RUB 7 billion. As a result, Sistema’s effective stake in Binnopharm Group together with its financial partner (VTB Bank) stands at 75.3%; a consortium of investors consisting of the Russian Direct Investment Fund (RDIF), the Russia-China Investment Fund (co-founded by RDIF and China Investment Corporation) and leading Middle Eastern funds holds 12.5%; VTB Capital, represented by Nevsky Property Investments Limited, holds 11.2%. The remaining 1% of shares in Binnopharm Group are owned by a minority shareholder (an individual). Binnopharm Group is a full-cycle Russian pharmaceutical holding company that combines five production sites located in different regions of Russia: JSC Alium (formerly OBL Pharm in the Serpukhov district of the Moscow region), JSC Binnopharm (two sites: Zelenograd and Krasnogorsk), OJSC Sintez (Kurgan) and CJSC Biocom (Stavropol). The Binnopharm Group companies produce a wide range of drugs across therapeutic groups and have the largest portfolio of drugs among Russian manufacturers (more than 450 marketing […]
German biotechnology company BioNTech SE, based in Mainz, and Siemens intend to expand their strategic cooperation. The companies plan to intensify their collaboration for the rapid expansion and creation of production capacity for the Covid-19 vaccine. BioNTech has expressed its aim of establishing new production sites for Covid-19 vaccine production worldwide based on the Marburg plant and its technology, starting with a production facility in Singapore. In Marburg, BioNTech has converted an existing plant into a vaccine production facility with support from Siemens in just five months. Within this cooperation, Siemens will provide the latest automation and digitalization technologies for BioNTech production sites, such as design, simulation, and engineering software as well as process control technology.
Walmart announced the launch of the first-ever private brand analog insulin, which will revolutionize the access and affordability to diabetes care by offering customers a significant price savings without compromising quality. Available exclusively through Walmart’s private ReliOn brand, the new offering includes analog insulin vials ($72.88) and FlexPen® ($85.88). These products will save customers1 between 58% to 75% off the cash price of branded analog insulin products, which translates to a savings of up to $101 per branded vial or $251 per package of branded FlexPens®. The new private label ReliOn™ NovoLog® Insulin (insulin aspart) injection, manufactured by Novo Nordisk, is available in Walmart pharmacies this week, and Sam’s Club pharmacies in mid-July across the United States. ReliOn™ NovoLog® is a rapid-acting insulin analog used to control high blood sugar in adults and children with diabetes. Customers will need a prescription in order to purchase the products and should always consult with their doctor regarding their diabetes management. “We know many people with diabetes struggle to manage the financial burden of this condition, and we are focused on helping by providing affordable solutions. We also know this is a condition that disproportionately impacts underserved populations. With ReliOn NovoLog® insulin, we’re […]
Russia should minimize its dependence on imports of ready-made medicines and pharmaceutical substances, Russian Deputy Prime Minister Tatyana Golikova said on Thursday. /TASS/ “In 2020, we updated the list of drugs strategically important for the country, the production of which should be in a full cycle [created within Russia — TASS]<…> The pace [of production] is important here. Of course, the production of cardiovascular and oncological drugs means long cycles of preclinical and clinical trials, but our work with vaccines has shown that we know how we can, and so we must. We must minimize our country’s dependence on imports <…> both on foreign pharmaceutical substances and on ready-made medicines,” she said at the final board of the Industry and Trade Ministry. Golikova recalled that in 2020, the government updated the list of 215 strategically important drugs, the production of which should be fully located in the country. By 2024-2025, a full production cycle in Russia should be provided for 65% of such drugs, by 2030 — for 80%, the Deputy Prime Minister emphasized. “These are mainly painkillers, cardiovascular and oncological drugs <…>”, Golikova specified.