Vaccine production manufacturing

Biological medicinal products manufactured by these methods include vaccines, immunosera, antigens, hormones, cytokines, enzymes and other products of fermentation (including monoclonal antibodies and products derived from rDNA). 

The market for vaccines is not working well currently. In recent years shortages of vaccines have occurred with alarming frequency. Moreover, there is a widespread view among the experts that existing levels of investment in vaccine R D are insufficient to exploit the many opportunities that exist for vaccine innovation that could save millions of lives as well as reduce losses from morbidity that could potentially be averted. Concerns about insufficient investment and ultimately suboptimal levels of vaccine production have led to two major proposals, which represent substantial departures from current practice (1) policies to encourage entry of nonprofit vaccine manufacturers and (2) new financial incentives to elicit innovative activity. 

The skills and knowledge of those in all chentical and chentical engineering disciplines are needed for these processes. Additionally, collaboration among the disciplines must be cultivated—especially between researchers who synthesize new chenticals and materials and those who develop new processes to manufacture them. There must be parallel integration of fields, so that discoveries quickly lead to useful technology. In a terrorist attack, a quick response is essential, whether it be decontamination of a site or scale-up of drug or vaccine production. 

Second, the vaccine industry is small and unstable. It basically consists of four major pharmaceutical firms many smaller, older vaccine manufacturers and a number of biotech firms. In 2001, the dominant vaccine manufacturers in the U.S. market were Merck, Aventis Pasteur, Glaxo, and Wyeth-Ayerst (now Wyeth). Annual vaccine sales for these four firms are in the 1 billion range for each of the first three companies and around 500 million for Wyeth. Recent reports, such as those on the shortage of influenza vaccine, indicate that these firms confront a number of problems in vaccine production. A number of smaller firms hold FDA licenses for vaccines based on technology from earlier eras and face disincentives, including prohibitively high capital costs, to upgrade production capabilities to... 

The contrast between vaccine production in prior years and today is substantial. John Dingerdissen, former senior director of Viral Vaccine Manufacturing at Merck, characterized it in the following way ... 

Likewise, each unit of blood or blood component remains highly controlled through control of manufacturing, often more to control or prevent infectious disease transmission than to protect the red blood cells or platelet products from degradation. Just as plasma or vaccine products are controlled from the very start of manufacture or collection of source material, so is blood for transfusion or further manufacture. 

The definition of a process based on biotechnology is sufficiently broad to capture a wide arrange of medicinal products, such as recombinant proteins and gene-based therapeutics, and prophylactics, such as gene transfer medicinal products and DNA vaccines. Medicinal products manufactured by biotechnological processes as defined in the Annex to Regulation (EC) 726/2004 must be authorized centrally pursuant to article 3 of the Regulation. 

Adverse events secondary to vaccine products have inspired lawsuits against vaccine manufacturers. Two theories of tort (duties created by law regarding professional conduct) are reviewed when litigation against a vaccine manufacturer ensues. The first regards safe vaccine development, with a vaccine manufacturer strictly liable for defective vaccine products. Liability cases involving defective vaccines rarely occur, and manufac-... 

Health care practitioners administering vaccines covered by the NCVIA are required to record pertinent information in either a permanent patient record or a vaccine log. The patient s name, date of administration, vaccine name, manufacturer, lot number, provider name, address, and title are all required. Administration of a NCVIA-co-vered vaccine also requires practitioners to give vaccine information statements (provided by state health departments and the CDC at www.cdc.gov/nip/publications/VIS/ default.htm) to patients or guardians outlining product use, benefits, risks, and warnings.Pharmacists involved with the administration of pneumococcal, influenza, and other vaccines should also adopt this practice. 

In fact, pharmaceutical biotechnology is one of the key industries today. Recombinant DNA technologies have entered drug discovery and all fields in the development and manufacture of therapeutic proteins and nucleotides. Biotechnology has a major impact on pharmaceutical industry because recent advances in recombinant protein chemistry, vaccine production, and diagnostics have and will revolutionize the... 

In many countries an inactivated mouse brain-derived Japanese encephalitis vaccine (JE-MB), manufactured in Japan by The Research Foundation for Microbial Diseases of Osaka University (Biken, Osaka, Japan), has been licensed and used since the 1990s. In 2006, production of JE-MB was discontinued, and supplies are limited. Other JE vaccines, including live-attenuated JE vaccine, are manufactured and used in Asia, but are not licensed for use in the USA and the EU. In 2009, the Food and drug Administration (FDA) and the European Medicines Agency (EM. approved the inactivated JE vaccine Ixiaro for use in people aged 17 years and over. Ixiaro is a Verocell-derived JE vaccine developed by Intercell. The vaccine was... 

Medical and diagnostic products, such as monoclonal antibodies, insulin, interferon, various cell-line stimulating factors, anti-clotting agents, enzyme inhibitors, steroids, antibiotics as well as bacterial and viral vaccines, are manufactured by means of aseptic fermentation from different raw materials by microbial and animal cell cultures. 

VelUnga J, Smith JP, Lipiec A et al (2014) Challenges in manufacturing adenoviral vectors for global vaccine product deployment. Hum Gene Ther 25 318-327... 

The problem of cost has been direcdy reflected in the loss of American companies involved in vaccine production. In 1967, thirty-seven companies in the United States manufactured vaccines, but by 1984, less than half of those companies continued to manufacture vaccines, and by 2005, only three companies remained in the business. During the same period, the actual number of licensed vaccines fell from 380 to fewer than 40. The reluctance of companies to engage in vaccine production and the long production... 

Challenges are also posed in bringing existing vaccines to technologically undeveloped nations, where they are needed most. This problem is almost exclusively dominated by the cost of vaccine manufacture and the reliability of distribution. Hence it is fertile ground for engineering improvements in vaccine production. 

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