The Pilot Bioproduction Facility (PBF) is a cGMP Contract Manufacturing Organization (CMO) that produces bacterial and viral vaccines for use in Phase I and II clinical trials. Over 1750 production lots have been produced during 19 years of continual operation. Products manufactured at the PBF have been submitted in over 100 Investigational New Drug Applications (INDs) and two products initiated at the PBF have achieved FDA licensure. The PBF has a fully developed Quality Assurance (QA) documentation system described in a Quality Manual that is available upon request. For over 10 years, ClinicalRM has provided highly qualified staff to operate the PBF.
The following cGMP services are available at the PBF:
The PBF works to maximum capacity using five clean rooms (CR) for cGMP production. Each CR is fitted for a specific manufacturing segment or campaign (i.e., cell banking, fermentation, purification, aseptic filling, and viral production). The CRs can be used every two weeks for different products, with a one-week down time during which robust cleaning and testing procedures ready the CR for a new campaign. Time in the CR is used efficiently and planned production schedule timelines are met over 90 % of the time.
Production dates are scheduled shortly after clients enter into Cooperative Research and Development Agreements (CRADAs), the agreement required for manufacturing at a government facility. Teleconference and/or face-to-face meetings are scheduled regularly to ensure that the technical aspects required to manufacture the client’s product are fully understood. Batch Production Records (BPRs) are written by the PBF staff, submitted to the client for review, and then signed off by both parties. Production from master cell bank to final finished product can be achieved in six months. The PBF is flexible and can perform not only all manufacturing from master seed to final product, but also specific manufacturing campaigns. For example, the PBF can manufacture a cell bank or perform an aseptic fill of a cGMP bulk product sent by the client to the PBF. The well-trained PBF staff work with every client to produce a product that meets FDA requirements for evaluation in Phase I-II clinical trials.
Vaccine Production on a Deadline
Filling the Gaps