HPA Case Study: Development of a Manufacturing Process for a Biodefence Vaccine

19 December 2011 by Health Protection Agency

The Process & Analytical Development Group (PADG) has recently completed the final development of a manufacturing process for an important biodefence vaccine on behalf of a US contractor. The vaccine's active ingredient was a recombinant fusion protein of two key antigens expressed in a bacterial host. The manufacturing process for this protein entailed batch fermentation followed by extraction of the product from the cells and purification. When originally transferred to the HPA, the process was low yielding, complex and presented scale-up difficulties impacting upon commercial viability.

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