Date: 6-1-09 Time 2:00pm
A telecon was convened to inform Isolagen that a pre-license inspection (PLI) will be conducted at their Exton, PA facility from Aug. 31 to Sept. 4, 2009.
The sponsor was informed that the CBER inspection team will include:
Dr. Gang Wang (Lead), Biologist, OCBQ/DMPQ
Dr. Randa Melhem, CSO, OCBQ/DMPQ
Dr. John Thomas, Biologist, OCTGT/DCTG
Dr. Donald Fink, Biologist, OCTGT/DCTG
The Inspection team may also include an inspector from the PA District Office, ORA upon confirmation.
A list of Information Request related to the PLI will be provided to the sponsor at least two weeks prior to the inspection.
With regard to manufacturing the sponsor was informed that the following would be required to be observed during the period of inspection:
- Biopsy receipt/processing – ---------(b)(4)------------------------
- Harvesting of bulk Drug Substance – ----------(b)(4)-----------------
- A fully operational QC lab running various lot release tests
- Drug Product-Injection – --------(b)(4)-------------- and final container filling procedures
The sponsor agreed to provide for the above requirements and would submit a proposed manufacturing schedule to the inspection team for review and approval. The sponsor will attempt to stagger the major processing steps described above so that each will be available for inspection.
Jeanne Novak, Ph.D., Authorized Regulatory Representative
Kevin Hennegan, M.A., Regulatory/Scientific Consultant
Jessica Allmond, M.A.S., RAC, Clinical/Regulatory Consultant
Declan Daly, CEO, Isolagen
John Maslowski, M.S., CQA, VP Operations, Isolagen
Karen Donhauser, Director of Quality, Isolagen