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)
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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 […]
The factory, which will be located on a 42 hectare greenfield site is planned to be operational by 2023, will be run by Recipharm and will mirror the company’s new fill finish line at its facility in Monts, France on a larger scale.
EMA has started evaluating an application for the use of a booster dose of Comirnaty to be given 6 months after the second dose in people aged 16 years and older. Booster doses are given to vaccinated people (i.e. people who have completed their primary vaccination) to restore protection after it has waned. EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by the company that markets Comirnaty, including results from an ongoing clinical trial in which around 300 adults with healthy immune systems received a booster dose approximately 6 months after the second dose. The CHMP will recommend whether updates to the product information are appropriate. The outcome of this evaluation is expected within the next few weeks, unless supplementary information is needed, and will be communicated by EMA. Separately, EMA is also assessing data from the literature on the use of an additional, third dose of an mRNA vaccine (Comirnaty or SpikeVax) in severely immunocompromised people (i.e., with weakened immune systems). People with severely weakened immune systems who do not achieve an adequate level of protection from their standard primary vaccination may need an ‘additional’ dose as part of their primary vaccination. EMA […]
Servier, a global independent pharmaceutical Group, and PRISM BioLab, a Japan based biotechnology company with proprietary small molecule drug discovery platform, “PepMetics™Technology”, today announced that they have entered into a Collaboration and Exclusive License Option Agreement. Under the collaboration agreement, PepMetics™ technology provided by PRISM BioLab are utilized to identify from their library or synthetize, characterize, and optimize small molecule compounds capable of binding and stimulating the activity of the target specified by Servier. Wesley Blackaby, Ph.D, Head of Chemistry at Servier says: “We look forward to working with PRISM BioLab in this collaboration. The PRISM BioLab technology has the potential to help with the identification and optimization of novel compounds against hard to drug targets, in particular in cancer, which is one of the Group’s priority R&D areas.” Upon finding the lead compounds, Servier has the option to license the lead compounds for further optimization and clinical development. PRISM BioLab will receive collaboration fee and option fees payments under the Option Agreement, and further milestones and royalty payments under the License Agreement. Specific financial terms are not disclosed. Dai Takehara, President and CEO, PRISM BioLab, says: “We are delighted to partner with Servier who is committed to delivering therapy […]
The production of Sputnik V, a vaccine for the coronavirus developed by Russia, began at an Iranian company on Saturday, 26 June. In a ceremony attended by Iranian Health Minister Saeed Namaki, the production of Russia’s Sputnik V vaccine under license started in Iran. Iran has become the first country in the Middle East to produce Sputnik V. The vaccine produced in Iran will be used in the national vaccination program. To date, Sputnik V has been registered in 67 countries globally with a total population of over 3.5 billion people. The data obtained by regulators of a number of countries during the vaccination of the population, including Argentina, Serbia, Bahrain, Hungary, Mexico and others, demonstrates that Sputnik V is one of the safest and most effective vaccines against coronavirus. Sputnik V is based on a proven and well-studied platform of human adenoviral vectors and uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots. Officials say the permission for the rollout of another homegrown vaccine developed jointly by Cuba and the Pasteur Institute of Iran will be granted in the […]
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).
A COVID-19 vaccine developed by a unit of China’s Chongqing Zhifei Biological Products (Zhifei) showed an 81.76% efficacy rate against COVID-19 cases of any degree of severity in a large, late-stage trial, Zhifei said on Friday.
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 […]
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.
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 […]
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 […]
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.
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 […]
Haikou city, the administrative center of Hainan, announced the opening of the island’s first modern pharmaceutical equipment maintenance facility, TASS reports with a reference to the Hainan Daily. According to the newspaper, this structure was established by the provincial pharmaceutical control authority in cooperation with the Haikou National Hi-Tech Industrial Development Zone Committee. The new facility is located within the zone, which is expected to greatly accelerate the development of an advanced healthcare cluster and advanced medical services in Hainan. After the opening ceremony, the authorities separately organized meetings with pharmaceutical companies, medical equipment manufacturers, and cosmetics companies. Representatives of these organizations expressed their wishes and opinions on government measures concerning the development of new drugs, elimination of hidden risks, and stimulation of intensive industry development. According to the Chinese government’s plan, Hainan is to become a major international health tourism center. In February 2013, the Chinese State Council approved an initiative to form an advanced pharmaceutical cluster on the island. To this end, the Lecheng Innovation Zone was founded in the east of the region. It is just a short car ride away from the site of the annual Boao Asian Forum and is considered to be the island’s […]
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. GMP rules 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.ru the 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 […]
Crohn’s disease and ulcerative colitis are severe chronic bowel diseases for which there are no effective drugs yet. The main approach in their therapy is to take drugs that reduce inflammation and restore the intestinal mucosa. At the same time, there are still no funds on the market that can gradually release an active substance inside the body, which could significantly increase the effectiveness of therapy. Under the leadership of the Federal State Budgetary Institution “CSP” of the FMBA of Russia, scientists from the N.N. DI Mendeleev developed a technology for obtaining such a dosage form: they created enteric capsules containing a biopolymer complex that releases an active substance at a controlled rate, which ensures a prolonged action and high bioavailability of the drug. Crohn’s disease and ulcerative colitis are severe chronic inflammatory bowel diseases of a non-infectious nature. According to statistics, they affect more than 23 million people around the world, while the frequency of detection of these diseases is increasing every year, and most often they are sick in developed countries and regions with a high level of urbanization. The exact figures for Russia are unknown, but according to various estimates, the prevalence of ulcerative colitis and Crohn’s […]
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, […]
Sai Life Sciences, a leading global Contract Research, Development & Manufacturing Organization (CRO-CDMO), announced the opening of a new biology facility at its integrated R&D campus in Hyderabad, India. The facility marks an important milestone in the journey of positioning itself as a differentiated player in Discovery Biology. Making the announcement, CEO & Managing Director of Sai Life Sciences, Krishna Kanumuri said, The new facility marks the culmination of a journey we began two years ago, of creating differentiated value for our discovery clients through an integrated delivery model across Boston and Hyderabad. Continuing with the company’s aggressive growth in its biology services, the new state-of-the-art facility houses expanded in vitro and in vivo biology services, DMPK, toxicology and a vivarium. In this new facility Sai Life Sciences is augmenting both, its capabilities and capacity, to deploy cutting-edge platforms and technologies for accelerating integrated drug discovery programs. Boston-Hyderabad integrated delivery model Sai Life Sciences has been steadily growing its biology capabilities to complement its strong foundation in medicinal chemistry, DMPK and toxicology for supporting its customers across the entire drug discovery journey from target ID and validation to IND. In 2019, the company opened its first international R&D facility with […]
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.
A Wuhan-based affiliate of China National Pharmaceutical Group (Sinopharm) said the start of operations at a new factory will raise the annual production capacity of its COVID-19 vaccine to at least 1 billion doses.
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, […]
Human Vaccine LLC, a wholly owned subsidiary of the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announces the signing of an agreement for the supply of 220 million doses of two-dose Sputnik V Russian COVID-19 vaccine with the United Nations International Children’s Emergency Fund (UNICEF). This amount is sufficient to vaccinate 110 million people. The supply agreement with UNICEF for Sputnik V vaccine will broaden access to help meet vaccine demand around the world. Procurement and delivery of the vaccine by UNICEF is subject to the vaccine receiving WHO Emergency Use Listing. The decision is expected soon on the Sputnik V application for WHO Emergency Use Listing that was submitted in October 2020. Concurrently, RDIF will be holding a separate discussion with Gavi, the Vaccine Alliance to see the Sputnik V vaccine considered for inclusion in the COVAX Facility’s Portfolio of COVID-19 vaccines. The COVAX Facility (co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO) together with UNICEF aims to help end the acute phase of the global pandemic by the end of 2021 by providing rapid, fair and equitable access to safe and effective vaccines to all participating countries and territories regardless of income level, thus enabling […]
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 research center of the university will be engaged in the development of new drugs for Russia with improved characteristics of safety and bioavailability profiles, increased stability and ease of use. First of all, they will be innovative pharmaceuticals for women’s health, reproductive medicine, neurology and immunology.
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.
Cuba will supply large quantities of its home-grown COVID-19 vaccine, Abdala, to Vietnam and also transfer the production technology to the Southeast Asian country by the end of the year, the Vietnamese health ministry said on Tuesday.
Yposkesi, a leading Contract Development and Manufacturing Organization (CDMO) specializing in cell and gene therapies, announces the launch of project SKY, the construction of Yposkesi’s second commercial cell and gene therapy facility and new global resource for drug developers of biologics, also called ATMPs (Advanced Therapy Medicinal Products). ATMPs treat patients living with rare and life-threatening diseases. To accelerate innovation, in March 2021 Yposkesi welcomed SK Pharmteco, a global CDMO player, as a new majority equity shareholder in its company. Backed by SK Pharmteco, Yposkesi is investing €58M (approx. $71M) in the new 5,000m² site, making it one of the largest ATMP facilities in Europe. Project SKY will create approximately 80 new jobs by 2023. With this new state-of-the-art facility, designed for European and American GMP compliance, Yposkesi will double its production surface to 10,000m². This new resource equips it to address the shortage in manufacturing capacity for drug developers seeking to advance clinical trials and commercialize new therapeutic drugs. Yposkesi is proud and excited to embark full speed on this new phase in our development. SKY is the culmination of our industrial strategy, guaranteeing clients a range of quality services from early clinical drug development through all phases to […]
The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) today announced the Russian single-component Sputnik Light vaccine against coronavirus has been approved by the Ministry of Health of the Republic of Armenia. Sputnik Light vaccine based on human adenovirus serotype 26 is the first component of the Sputnik V vaccine. Immunization with Sputnik Light will help Armenia to significantly reduce the infection rate in the country and create herd immunity in a short time frame. In February 2021 the two-dose Sputnik V vaccine was also approved in Armenia. Sputnik Light is safe and highly effective as demonstrated by the real-world vaccination data in a number countries. In particular, the data from the Ministry of Health of the Buenos Aires province (Argentina) shows 78.6-83.7% efficacy among the elderly. In Paraguay Sputnik Light is 93.5% effective during the ongoing vaccination campaign according to the country’s Ministry of Health. Thanks to its safety and efficacy, single-component Sputnik Light vaccine is now both used on standalone basis and also studied in combination with vaccines from other producers in a number of countries. The heterogeneous boosting approach (“vaccine cocktail” using human adenovirus serotype 26 as the first component and human adenovirus serotype 5 as […]
The Russian Direct Investment Fund (RDIF) announces the real world data of the Ministry of Health of San Marino on the Russian Sputnik V coronavirus vaccine confirming its high efficacy during the vaccination campaign in the country including against new variants of COVID. The efficacy of Sputnik V was measured based on the monitoring of COVID cases between 25 February and 23 August, 2021. Overall efficacy over 21 days after administering the first dose was estimated at 94.8% while efficacy against hospitalizations estimated at 95.9%. Sputnik V is the most efficient vaccine against hospitalizations with COVID-19 in the country. San Marino was the first country in Europe to defeat COVID and lift restrictions thanks to inclusion of Sputnik V in the national portfolio. Over 70% of the adult population has been vaccinated with Sputnik V. The Russian vaccine is demonstrating high safety profile with data published in EClinicalMedicine (an open access clinical journal published by The Lancet, one of the world’s most respected medical journals). In particular, Sputnik V shows high tolerability profile in ≥60 age group with nearly all reported adverse events following immunization being mild or moderate and lasting less than 2 days. Sputnik V has a number […]
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 […]
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 […]
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 […]
The global active pharmaceutical ingredient market stood at around $190 billion in 2020, and it is expected to reach approximately $300 billion by 2030. This can be attributed to the widening of the application area of drugs, expiration of patented biologics, increase in the incidence of chronic and lifestyle-associated diseases, such as cancer, diabetes, and cardiovascular diseases, rise in the geriatric population, government initiatives to promote generic drugs, investments in biosimilars, increasing healthcare expenditure, and surging awareness about diseases. Due to the COVID-19 pandemic, lockdowns were imposed by the government in several countries across the world, which disrupted the supply chain and economic activity during the first half of 2020. However, established pharmaceutical and biotech companies, as well as research institutes, stepped forward to develop a treatment against the coronavirus, which had a positive impact on the API market. Due to High Investments by Major Players, Captive Category Held Larger Share The captive category held the larger share in the active pharmaceutical ingredient market during 2015–2020, and it is expected to retain its position in the upcoming years, based on the type of manufacturer. This can be attributed to the easy availability of raw materials and surging investments by the […]
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.
Nanolek, a biopharmaceutical company, announces a plan to invest 5 billion rubles over 3 years in its full-cycle vaccine production facility in the Kirov region and an R&D Center for Biotech Medicines in Moscow.