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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Telecon with Isolagen, June 1, 2009 - Laviv

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. 

FDA Participants
  Lori Tull
  Terrig Thomas
Gang Wang

Isolagen Participants
  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