PDA published the subject document for access by industry personnel. The case study was developed to identify the differences in approach to QBD between a monoclonal antibody and a vaccine. The five companies, GSK, MedImmune, Merck, Pfizer, and Sanofi Pasteur – responded to the solicitation and committed to participate in the Vaccine Working Group (VWG). The main objective of the VWG was to work together to see if and how QbD could be applied to vaccine development and manufacturing.
As has been noted by FDA in ICH Q8, Quality by Design, and stated by the CMC working group, the value in implementing a QbD approach during development will result in the following:
- Better understanding of the product and process, considering the different implementation tools and approaches available to attain this understanding
- Robust and consistent processes with clear understanding of the impact of future process changes
- Expedited development and regulatory review
- Cost- benefit analysis framework
The document is lengthy with many tables, figures and charts. It provides a methodical, logical and thorough model to serve as an approach to vaccine development. It is certainly worth a look when you have a lot of spare time on your hands to digest the contents. Don’t take it on vacation.
Companies need to start using the terminology that FDA has identified in the ICH Q8, Q9 and Q10 documents. Words like: Target Product Profile, Critical Quality Attributes (CQAs), and Product Risk Assessment need to become everyday terms within the development arena, including the QA and QC groups. The establishment of CQAs and Control Strategies need to be more scientifically based and backed by experimental data. And, we need to relate the CQAs against a risk model (see pages 34-42 of the case study for a great example of how that is done).
The working group should be commended on doing an outstanding job in assisting our industry to take the guidelines from a theoretical to a practical position. It is evident that a lot of intelligent thought and work went into preparing this case study so that we may all benefit and comply with the FDA’s expectations for pharmaceutical manufacturing for the 21st century.