Veterinary Vaccine: Process Development sub map

Once lead candidates are identified, most vaccines will undergo process development in order to create a scalable, GMP, manufacturing process. In order to reduce costs, process development is generally a non-GMP operation. This stage identifies tolerances of the manufacturing process and its robustness, reproducibility and scalability are defined and tested. This can take several months to conduct. Therefore, if possible, Early Process Development studies should be conducted in parallel with Lead product(s) identification. However, at these early stages there may be insufficient material to test, thus identification of appropriate tools for early process development remains a limitation.

process development sub map

  1. Process Design
    1. Process Analytics (1. In process controls, 2. Product/Impurities Characterisation, 3. Release Assays (QA/QC) )
    2. Process Flowsheet and optimisation (1. Process Flow sheet, 2. Critical Process Parameters (CPP)/Critical Quality Attributes (CQA)s, 3. SOPs and sample data, 4. Master Seed Bank transfer and testing)
  2. Pilot scale-up studies
  3. Use of pilot lots in developmental studies

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