FDA encourages cell-based vaccine production
pharmafile | March 5, 2010 | News story | Manufacturing and Production |Â Â h1n1, swine fluÂ
The US Food and Drug Administration has issued a new guidance document designed to help encourage the adoption of cell-based vaccine production.
The move comes in the wake of the difficulties experienced by vaccine manufacturers in generating sufficient quantities of the influenza vaccine for the H1N1 pandemic – thankfully not a serious issue as the virulence of the virus was much less than feared.
The lessons learnt from H1N1 make it clear, however, that traditional production methods in chicken eggs are unlikely to meet the expected demand for vaccination in the event of a serious pandemic.
“This final guidance recognises that a new generation of medical products using innovative methods is needed to ensure we are better prepared today than we were yesterday,” said US Health and Human Services Secretary Kathleen Sebelius.
Cell-based production cuts the time it takes to produce the antigens used in vaccines from months to weeks compared to chicken egg-based production, allowing a more rapid response to emerging flu strains.
Currently, all licensed influenza vaccines in the US are produced in chicken eggs, although Novartis, Sanofi Pasteur, GlaxoSmithKline, MedImmune and Solvay have all put influenza vaccines made via cell-based production technology into trials. Solvay and Novartis have also launched cell-based flu vaccines in some European markets, including Germany, Switzerland and Russia.
The guidance – available to download here – covers elements such as the evaluation and testing of cell substrates, viral seeds and biological intermediates, cell banking, and test methods for use during production and to identify cell properties and adventitious agents.
The document is the culmination of more than 10 years’ work by FDA scientists and a major consultation exercise, according to the agency, which notes that it “outlines the best practices using current and emerging science to safely expand the types of cells that may be used to produce vaccines”.
The guidance is intended to sit alongside recommendations found in the International Conference on Harmonization (ICH) document Q5a (Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin) and Q5 (Quality of Biotechnological Products).
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