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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Dendreon PLI - Preliminary Report - February 16, 2010

(System Info - 126748 TULL LORI 04/22/2010 18:20:11 TULL)

From:             Melhem, Randa
Sent:             Tuesday, February 16, 2010 11:57 AM
To:                'lsmith@Dendreon.com'
Cc:                Wang, Gang; Finn, Thomas; Oh, Steven; Tull, Lori
Subject:         Dendreon PLI - Preliminary Report

Hi Liz,

Thank you for the preliminary report for the lots processed during the inspection.
For each lot, please provide in a Table format the time for each of the following steps:

  • Collection of APH at the Apheresis Site
  • Receipt of APH at Dendreon, NJ
  • Start of the manufacturing ( b(4) ) – (b)(4)
  • Start of incubation
  • Start of manufacturing of Drug Product – (b)(4)
  • Filling of Drug Product into Sipuleucel-T Primary container
  • Packaging of Drug Product in secondary shipping package
  • Collection of package by courier
  • Receipt of the Drug Product at the clinic
  • Infusion of the Drug product into the patient

Thanks again,

Randa Melhem, Ph.D.
Consumer Safety Officer
FDA/CBER/OCBQ/DMPQ
Phone: 301-827-6999 Fax 301-827-3536

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