Veterinary autogenous vaccines continue to conquer the world
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.
Konstantin Morozov, GMP Specialist, Auditor of Pharmaceutical Enterprises
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 they are needed to safeguard the lives of people and animals.
Autogenous vaccines can also be used to fight against multi-drug resistant bacteria. Finally, they can help support public health programs, for example by helping to control food-borne pathogens such as Salmonella and Escherichia coli by preventing these infections in poultry and pigs .
Wide use of autogenous vaccines
Today, autogenous vaccines are used in livestock farms around the world
These vaccines are used for the specific prophylaxis of various avian diseases – ornithobacteriosis, avian infectious rhinitis, pasteurellosis, ducks’ riemerellosis, turkey bordetellosis, salmonellosis, staphylococcosis, enterococcal infection. Such vaccines are also effective for the prevention of swine diseases – actinobacillus pleuropneumonia, hemophilous polyserositis, pasteurellosis, streptococcosis, staphylococcosis .
With the help of autogenous vaccines, it is possible to prevent diseases in cattle – pasteurellosis, neonatal enteritis, mastitis. It is possible to use vaccines for the prevention of such fish diseases as, for example, furunculosis and enteric redmouth disease .
Autogenous vaccines can be prepared for petswhen treatments fail to provide desired results
Diarrhoea caused by haemolytic Escherichia coli affects individual animals as well as dogs and cats of all ages in kennels and animal shelters. Vaccination causes increased production of secretory antibodies (IgA) in the gut. Thus, anchorage of bacteria and absorption of antigens (toxins) is inhibited. Staphylococcal pyodermatitis is the main field of application of autogenous vaccines in dogs.
These vaccines can be applied in chronic-recurrent infections of ears, nose and throat, for example, otitis of dogs or chronic rhinitis of cats, which are resistant to therapy with antibiotics. Viral papillomatosis can be treated with autogenous vaccines. Direct transmission of Microsporum canis to humans from dogs and cats does occur. Vaccination is recommended as an accompanying measure to standard therapy .
Autogenous vaccines can be in demand forthe preservation of rare species of animals and birds
Global change is contributing to unprecedented expansions of infectious diseases in wildlife. For example, recurrent avian cholera outbreaks are causing dramatic chick mortality and population decline in endangered albatross colonies on Amsterdam Island, a critical seabird breeding ground in the Southern Indian Ocean. Authors of the article-report «Vaccination protects endangered albatross chicks against avian cholera» identify a way of promoting resistance of endangered albatross populations to a major infectious threat.
Vaccine production was inspired from a process initially developed for the poultry industry. A killed vaccine has been manufactured using a Pasteurella multocida strain isolated from a dead albatross in the field. This same bacterial strain was used to establish a serological assay allowing the monitoring of antibody levels following bird vaccination. Using this vaccine on chicks 2 weeks post-hatching caused 100% seroconversion and reduced the death risk by a factor exceeding 2.5, raising fledging probability from 14% to 46%. These results suggest that using a specifically tailored vaccine could be a key tool to effectively protect endangered seabirds from disease outbreaks threatening them with extinction.
This tool should be of interest to governments, non-governmental organizations, and other sustainable development policy actors (such as the international Commission for the Conservation of Antarctic Marine Living Resources) involved in the conservation of wildlife threatened by emerging infectious diseases .
Global autogenous vaccines market
Persistence Market Research company (PMR) estimates that the global autogenous vaccines market was valued at over USD 400 million in 2018, and is expected to witness a CAGR of 4.4% in 2019-2029 [5, 6].
“Unavailability of licensed vaccines for bacterial and viral infections in animals has directed the focus of several small & large manufactures to invest in the manufacturing of autogenous vaccines, thereby propelling the growth of the autogenous vaccines market,” said a PMR analyst.
Key players operating in the autogenous vaccines market across the globe include Boehringer Ingelheim Animal Health, Elanco Animal Health, Ceva Sante Animale (Ceva), Phibro Animal Health, and Dyntec, among others.
Autogenous vaccine manufacturers are focusing on product portfolio expansion through partnerships with and acquisition of small veterinary biologics manufactures, in particular:
in 2017, Pharmgate and Cambridge Technologies entered into a strategic alliance to provide commercial, autogenous, and prescription vaccine solutions to veterinarians;
in 2018, Huvepharma acquired AgriLabs, to expand its presence in the US and speed up the commercialization of biologic products for animal health; the acquisition included AgriLabs’s custom vaccines business;
in 2019, Ceva completed the acquisition of IDT Biologika’s veterinary biopharmaceutical and R&D activities.
Moreover, manufacturers are focusing on expansion and advancement of their production facilities and research centers to produce custom vaccines. For instance, in May 2017, Elanco Animal Health opened a new manufacturing facility for the manufacture of autogenous poultry vaccines in Winslow, Maine [5, 6].
A new GMP plant built by Ceva Biovac and dedicated to autogenous vaccines is planned to deliver its first batches in April 2021.
In the second year of its presence, the Association of European Manufacturers of Autogenous Vaccines and Sera (EMAV) already has 21 members located in 12 European countries.
In several Workshop discussions EMAV members developed key elements of future manufacturing standards for autogenous vaccines – in execution of regulation (EU) 2019/6 of the European Parliament and of the Council. These findings were implemented in a draft of dedicated GMP rules for autogenous vaccines by the EMAV Scientific Working Group, an expert team from the EMAV membership experienced in regulatory procedures, quality assurance and manufacturing of vaccines [7, 8].
From the 14th until the 16th of September, 2021 at Ludwig-Maximilians-University Munich (Germany), the International Alliance for Biological Standardization Europe (IABS-EU) and EMAV are organizing the Autogenous Vaccines Meeting: “Quality of Production and Movement in a Common Market”.
The existing licensing procedures within the EU are demanding concerning the scientific requirements, the length, costs and complexity of procedures. Therefore, vaccines manufacturers tend to focus on the licensing and manufacture of products that have defined development pathways, demonstrated veterinary need, and reasonable expectations for a return on investment. As a consequence, the market for autogenous vaccines to meet “niche” customer needs increased despite a minimally-regulated situation, especially in terms of manufacturing quality. Herewith:
there is no mutual recognition of GMP or GMP-like certificates;
there are no harmonized provisions concerning the manufacture and control of autogenous vaccines, not to mention the non-communication and non-information of authorities concerning the movement of vaccines and vaccinated animals within the EU and beyond.
First attempt to harmonize some requirements was the CMDv paper on this item and now the revision of the vet legislation in the EU. The meeting is intended to initiate productive conversations with manufacturers, competent authorities and users to develop a draft proposal how to form a common market which will improve overall disease control in the Community. Key items will be: GMP/GMP-like requirements, mutual recognition of inspections, import and export of autogenous vaccines, relevance and impact on diagnostics and the information on vaccinated animals whenever they are moved to allow an epidemiological surveillance .
Autogenous vaccines in Russia – explanation of the competent authorities
The article “Right in a chain: is it possible to use autogenous vaccines in Russia” presents explanations given by representatives of the Russian competent authorities to the federal branch newspaper “Veterinary Medicine and life” (ViZh).
In Russia, the use of autogenous vaccines is still prohibited. Firstly, the very concept of “autogenous vaccine” is not fixed, explained to “ViZh” in the All-Russian State Center for Quality and Standardization of Veterinary Drugs and Feed” (FSBI “VGNKI” of Rosselkhoznadzor). The procedure for registration the manufacturing and use of this type of medicines is not legally prescribed. A uniform vaccine registration procedure, which lasts up to seven months, is not suitable for autogenous vaccines which must be registered a maximum of two months in advance.
To allow the use of autogenous vaccines, it is necessary to amend the Federal Law “On circulation of medicines” in terms of veterinary use, explained Anna Babushkina, the deputy head of the section for internal veterinary supervision of Rosselkhoznadzor, to “ViZh”. This can take at least two years. Due to the fact that each batch of autogenous vaccines is made only for a specific farm, it may be worth revising the state registration mechanism. “The issue requires discussion. It may be worth giving autogenous vaccines a special status to simplify the registration process,” she said .
Dialogue with an expert
Eric Thibault, Director for Clinical R&D and customer relations of Ceva Biovac site
Eric Thibault, Director for Clinical R&D and customer relations of Ceva Biovac site answered several of my questions about autogenous vaccines.
Eric, as far as I know,you have been taking part in a study alongside other scientists with the aim of protecting the albatross on Amsterdam Island.Could this tool be applied to the conservation of other rare species suffering high levels of bacterial disease mortality?
Absolutely, Konstantin, autogenous vaccines are a useful tool to prevent endangered species exposed to diseases. As these vaccines are customized, they are produced to match perfectly with each specific need of a species, according to the disease. Such projects are also amazing scientific and human experiences involving microbiologists, immunologists, ecologists and veterinarians. For instance, a minimum handling of the birds is required, as they are protected by law; but their life expectancy is around 80 years, with an immune system inducing high protective response to a vaccination. Consequently, we developed a vaccine specifically formulated to be administered with a single shot able to induce a strong and lasting protection.
In 2020, Ceva company has increased three-fold its production capacity for bacterial autogenous vaccines at its Ceva Biovac site.This tailored manufacturing offers flexibility in terms of batch sizes (1 to 200 L) and a production capacity of 300 batches per week.Could you tell me, please,is this production capacity a lot or a little in the scale of the total autogenous vaccines manufacturing in France?
Ceva Biovac already delivers vaccines in 15 European countries. The goal of this facility is not only to cover the needs of the French market but also those of other countries requiring high quality products. GMP is the highest quality standard of manufacturing proposed for medicinal products.
Let’s suppose that someday Russia decides to introduce the world experience of using such medicinal products into its practice. What do you think is needed to implement such an ambitious project as the organization of the autogenous vaccines manufacturing “from scratch”?
The prerequisite is to have a network of diagnostic labs experienced in the isolation and characterization of pathogens and able to ensure the traceability of isolates. Then, to define which standard of manufacturing is adapted to the country and implement the corresponding regulation. Finally train the field vets, as they are at the beginning -sampling- and the end -choice of the posology, route of administration and vaccination program- of the process. Indeed, the manufacturing itself is only a part of the success.
Yes of course! We’ll be happy to do it, mainly such sharing and partnership gives us the opportunity to offer our solutions to the Russian manufacturers.
The use of veterinary autogenous vaccines can prevent infectious diseases in various species of animals, as well as reduce the need for the use of antimicrobial medicinal products. Harmonization of manufacturing standards for these vaccines is a challenge and an expectation for the EU countries. The issue of using autogenous vaccines in Russia is still controversial but it is constantly growing interest.
The Commission for the Conservation of Antarctic Marine Living Resources (CCAMLR) is an international commission that, based on the best available scientific information, agrees a set of conservation measures that determine the use of marine living resources in the Antarctic
The Association of European Manufacturers of Autogenous Vaccines and Sera (EMAV) is an association that combines the interests of manufacturers of specific vaccines and sera for farm, companion and exotic animals, to promote the European harmonization process
The International Alliance for Biological Standardization for Europe (IABS-EU) was created to support the mission and projects of the International Alliance for Biological Standardization, to enhance its image and to develop its outreach within the EU. IABS-EU contributes to scientific and medical advancement of biologicals by facilitating communication among those who develop, produce and regulate biological products for human and animal health
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.
Young scientists from NUST MISIS have presented multilayer antibacterial coatings with a prolonged effect and a universal spectrum of action. The coating is based on modified titanium oxide and several antiseptic components. The coatings can be used in modern implantology as a protective layer for the prevention of concomitant complications – inflammation or implant rejection. The results of the work have been published in the international scientific journal Applied Surface Science. Antibacterial coatings are currently being actively researched, as the search for alternatives to traditional antibiotics is growing. They can be applied to implants, thereby preventing inflammation caused by nosocomial infections. Nevertheless, the creation of antibacterial, but at the same time biocompatible and bioactive surfaces is a problem that the scientific community has been solving for many years, and the “dream materials” have not been developed. Young scientists from the NUST MISIS Laboratory of Inorganic Nanomaterials have created an innovative multilayer coating that synthesizes the protective properties of nanoparticles, biopolymers, anticoagulants and antibiotics. The antibiotic and silver nanoparticles provide an antibacterial effect, while heparin prevents bacterial cells from sticking to the tissue surface, which reduces the amount of antibacterial agent required. The method of obtaining a multilayer coating is a […]
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Johnson & Johnson has shaken off another lingering liability claim in the US, agreeing a $263 million settlement with New York to resolve lawsuits focused on its role in the US opioid crisis. The last-ditch agreement over the weekend means that a jury trial due to start today will now go ahead without J&J, although other defendants will still be in the spotlight. J&J also said in a statement that it committed to exiting its opioid painkiller business altogether last year. While the company didn’t provide finished opioid drugs, J&J supplied raw materials used to make them, and has been accused by various US states of using deceptive marketing to say the drugs were effective for treating pain and were unlikely to cause addiction. The settlement relates to its marketing and promotion of Duragesic (fentanyl), Nucynta (tapentadol) and Nucynta ER products, which are no lomger on sale in the US. The opioid epidemic has wreaked havoc on countless communities across New York state and the rest of the nation, leaving millions still addicted to dangerous and deadly opioids, – said NY attorney general Letitia James, – Johnson & Johnson helped fuel this fire, but today they’re committing to leaving the opioid business […]
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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.
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Joint-stock company “Grindeks” has invested 800 thousand euros in the site of production of active pharmaceutical ingredients (APIs) and installed new, state-of-the-art laboratories and technological equipment for industrial production, which has allowed the unit to become multifunctional. After the investments, the facility will be used for the development and production of active pharmaceutical ingredients. They will be used for production of Grindeks finished dosage forms or medicines, as well as for export. The department has the opportunity to work with equipment with a volume of 100ml to 20l, which allows the production of various of active substances from milligrams to kilograms. To ensure the safety of workers and the protection of the environment, a reduced-pressure insulator with filtration systems has been installed for production to prevent highly effective API contact with humans and the environment. This is the first device of its kind in the Grindeks API factory. The site is also equipped with a modern monitoring and communication system for rapid response in case of non-standard situations. Chairman of the Council of JSC Grindeks Kirovs Lipmans: “For the Grindeks Group to be able to grow rapidly, investments are necessary for the development of production. Every year we invest at […]
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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 […]
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.
Today, the domestic COVID-19 vaccine QazVac has been officially registered in the Kyrgyz Republic! The Ministry of Health and Social Development of the Kyrgyz Republic issued a registration certificate (KG.1.11159.08560-2021) on the state registration of the COVID-19 vaccine QazVac.
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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 […]
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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.
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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 […]
Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced enrollment of the first participants in a Phase 1/2 study to evaluate the safety and immunogenicity of a combination vaccine using Novavax’ seasonal influenza and COVID-19 vaccines. The clinical trial combines Novavax’ recombinant protein-based NVX-CoV2373 and NanoFlu™ vaccine candidates and patented saponin-based Matrix-M™ adjuvant in a single formulation (COVID-NanoFlu Combination Vaccine). Both NVX-CoV2373 and NanoFlu have previously demonstrated strong results as standalone vaccines in Phase 3 clinical trials. “This study is the first-of-its-kind to evaluate the vaccine’s potential to induce a robust immune response, augmented by our Matrix-M adjuvant, against two life-threatening diseases simultaneously,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “The combination of these two vaccines, which have individually delivered outstanding results with favorable safety and tolerability profiles, may lead to greater efficiencies for the healthcare system and achieve high levels of protection against COVID-19 and influenza with a single regimen.” The trial will evaluate the safety, tolerability and immune response to NanoFlu formulated together with NVX-CoV2373 and Matrix-M adjuvant in 640 healthy adults 50 to 70 years of age. Participants will have been either previously infected with the […]
In October 2020, the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) announced that from January 1, 2021, the Rules of Good Manufacturing Practice of the Eurasian Economic Union, approved by the Resolution of the Council of the Eurasian Economic Commission of November 3, 2016 No. 77, will come into force, in relation to medicinal products for veterinary use. Compliance with these Rules will be taken into account when issuing permits (licenses) to manufacturers of medicinal products for animals for these activities, as well as when inspecting them . In this short overview, we’ll look at some of the articles, presentations and documents that veterinary manufacturers may find useful. EAEU GMP rules The text of the Rules of Good Manufacturing Practice of the Eurasian Economic Union (the EAEU GMP Rules) is published on the website of the Eurasian Economic Commission (EEC) in the section “Resolutions of the Council of the Eurasian Economic Commission” . The EAEU GMP rules were approved in 2016. They entered into force in 2017, with the exception of the provisions of these Rules concerning the requirements for the production of veterinary medicinal products. The requirements of the EAEU GMP Rules for the manufacture of veterinary medicinal […]
The Chumakov Center plans to double the production of the CoviVac whole-virion vaccine against the coronavirus to 2.5 mln doses per month in October 2021, Director General Aidar Ishmukhametov said in an interview aired by the Rossiya-24 TV news channel on Tuesday, TASS reports. We spoke for three months about the technical upgrade we expected, and finally, we received reactors two weeks ago. Two reactors mean a breakthrough for us, a principal modernization. We managed to install them properly. Basically, we will use them for the first time since the creation of the vaccine as early as the end of this week. We suggest that we will be able to plan at least a doubling of the production to 2.5 mln [doses of CoviVac vaccine] per month starting October. It will be clear at the end of September. The inactivated whole-virion CoviVac vaccine was developed by the Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (known as the Chumakov Center) was registered with the Russian Health Ministry on February 19. Whole-virion vaccines are based either on artificially weakened viruses incapable of causing a disease or killed (inactivated) viruses. Four coronavirus vaccines have […]
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.
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 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 […]
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 […]
The R&D centre is tasked to optimise its substance manufacturing process and develop new unique molecules. The complex has modern and high-precision equipment that allows to: optimise technologies for synthesising generic drugs, develop synthesis methods and produce substance samples for clinical and preclinical studies, validate analytical procedures to control the quality of active pharmaceutical ingredients. The laboratory is also unique since it is in touch with production, which allows transferring laboratory scale developments faster to the industrial level. It is also possible to carry out advanced multi-stage syntheses, which helps reduce substance prices and import dependence. More than 20 synthetic chemists, analytical chemists and operators work in the laboratory that is in active search for personnel and recruitment.
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 […]
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 […]
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.
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 […]
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 […]
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 […]
The FDA evaluated information on the use of a third dose of the Pfizer-BioNTech or Moderna Vaccines and determined that the administration of third vaccine doses may increase protection in this population.