PCS has helped a U.S.-based manufacturer of a novel protein platform with full GMP implementation for it's manufacturing sites in the U.S.
The consultancy services were rendered over a number of years, including support for re-construction and setting up the manufacturing process - including tech transfer.
PCS assisted with (at least) the following activities for the client;
- Supply an interim vice president corporate Quality Assurance,
- Drawing up plans for the reconstruction of a facility,
- Create a manufacturing strategy,
- Supervising clean construction management,
- Selection of contractors,
- Budgets,
- Equipment purchase,
- Validation, qualification,
- Quality system implementation and supervision.
Other support included mapping the full production process, drawing up a production schedule, developing the cell bank and liaising with the U.S. FDA as well as suppliers and clients worldwide.