Situation

An international biotech company headquartered in the United States required assistance in developing their process and assays to process their viral vaccine that was in phase II trials.  This included a wish to identify suitable CMOs that could be engaged.  In addition, they wished improve their understanding of critical process parameters for the manufacturing process in preparation for phase III clinical trials.

GRA Involvement

1) To identify and engage with a suitable CMO for drug product production, 2) To assist in the development of a lyophilised product, 3) To improve their understanding of the process critical process parameters (CPPs).

Value Added

Assisted the organisation in developing a lyophilised product, working with a number of organisation to develop a commercially scalable lyophlised product.  In addition, GRA identified and engaged the organisation with a CMO that could produce the drug product for phase III production and product launch.

GRA also performed risk assessment and FMEA analysis on the manufacturing process providing information that was used in the PPQ of the process through the identifying critical process parameters (CPPs) impacting upon product CQAs.

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