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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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01/06/2009 Telecon - RiaSTAP

Memorandum

Date:January 6, 2009
To: File, BL 125317/0
 From:Rebecca Olin, CBER/OCBQ/DMPQ/MRBII
Subject:Memo of Telecon with CSL Behring

On January 6, 2009 Dave Doleski, Branch II Team Leader, and I called CSL Behring and requested a telecon to discuss the validation of the lyophilization cycle. We spoke with the following CSL representatives:

  • David Desris, PharmD, Sr. Manager Regulatory Affairs (CSL Behring LLC, US)
  • Kathryn Gray, Manager, Regulatory Affairs (CSL Behring LLC, US)
  • Thorston Keller, Manager, Regulatory Affairs/Establishment) (CSL Behring GmbH, Germany)

I asked them the following question:

  1. Were temperature probes placed within the product during the process validation of the lyophilization cycle? If not, please provide a PMC in which you commit to performing one validation run using probes within the product.

Dave Doleski explained that the validation run could be a combination of product and placebo but that probes should be included in the product containers.

Thorson Keller stated he would check with the validation department. Dave Desris stated that if the validation was not conducted using product probes then they would commit to conducting an additional validation run using them.

Dave Doleski provided additional guidance by stating that the probes should be external probes and that there should be at least five probes per shelf. The telecon was ended.