


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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