Situation

A multinational pharmaceutical organisation required assistance in developing, optimising and validation of their assay in preparation for phase III clinical trial.  In addition, they required a comprehensive characterisation package for the product to provide greater insight into the vaccine and its mechanism of action that can be used in understanding product Critical Quality Attributes (CQAs).

GRA Involvement

• To understand what assays are required and advise on their vaccine development.
• Ensure that assays are robust and reliable prior to validation.
• Oversee validation of bulk and drug product assays.
• To oversee a comprehensive product characterisation package.

Value Added

• Assisted in identifying and helping in the development and optimisation of release and in process assays.
• Led the Design of Experiments (DoE) approaches for the optimisation of a plaque based potency assay.
• Oversaw successful validation of all assays at a commercial launch scale CMO.
• Generated a comprehensive characterisation package that was submitted to regulatory agencies and provided product understanding in support of phase III process validation.

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