Vaccine process & formulation development

Situation

A US site of a multi-national pharmaceutical company required assistance in developing their process and assays to process their viral vaccine that was in phase II clinical trials.  The client wished to identify suitable CDMOs that could be engaged.  In addition, they needed to build their understanding of the process' critical process parameters(CPPs) so that the manufacturing process was suitable for the coming PPO campaign in preparation for phase III clinical trials.

GRA Involvement

1) To identify and engage with a suitable CDMO's for drug product production

2) To support the client in 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 lyophilised product.  In addition, GRA identified and engaged the organisation with a CMO that could produce the drug product for phase III production and from where the product was launched following EMA licence approval in 2023.

GRA also performed risk assessments via FMEA analysis in line with QbD principles on the manufacturing process. This provided information used during the PPQ of the process by identifying critical process parameters (CPPs) that impacted upon product CQAs.

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