The Pre-GMP Team provides a smooth transition of novel products from academic research groups and collaborators to GMP manufacture. Pre-GMP processes are performed in dedicated laboratory spaces using dedicated equipment and materials for production of Pre-GMP Starting Materials.
The production of a viral vector Pre-GMP Starting Material, the precursor to vaccine production, takes place over several months during which the Pre-GMP Team will:
- Begin the process working with DNA in the early stages of vaccine development
- Recover and propagate the adenoviral vector in cells in a controlled environment, producing larger quantities while ensuring the quality and stability of the adenoviral vector by thorough testing throughout the process
- Purify the adenoviral vector to create the Starting Material for the CBF’s Production Team to begin GMP manufacture
- Perform genetic stability studies of the Pre-GMP Starting Material to ensure the highest quality vaccine is being produced
Process Development is a critical aspect of product development that aims to reduce the costs, risks and timelines for projects entering GMP manufacture. Process Development studies can involve:
- Technical transfer of an existing process from research project to GMP manufacture
- Optimisation of an existing process to improve product yield or to decrease time spent in the cleanrooms during GMP Manufacture
- Development of a new process for GMP manufacture
- Assay development and optimisation to improve process knowledge
- Assay qualification to ensure that assays used for product release testing are accurate, precise and reproducible.