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Vaccines, Blood & Biologics

1/18/2008 Telecon - Seraclone Blood Grouping Reagent Anti-S (Monoclonal)



Date/TIme:January 18, 2008 / 11:35 AM
CBER Representatives:Najma Khan, CSO, DRB
Biotest’ Representative:Pamela J. Vaughan
Subject:Discuss additional information required for submission.
To:File of STNs listed below


Submission Tracking Numbers

Product Proper Names

BL 125219/0Blood Grouping Reagent, Anti-A (Murine Monoclonal)
BL 125220/0Blood Grouping Reagent, Anti-B (Murine Monoclonal)
BL 125221/0Blood Grouping Reagent, Anti-A,B (Murine Monoclonal)
BL 125224/0Blood Grouping Reagent, Anti-M (Murine Monoclonal)
BL 125225/0Blood Grouping Reagent, Anti-N (Murine Monoclonal)
BL 125230/0Blood Grouping Reagent, Anti-K (Monoclonal)
BL 125232/0Blood Grouping Reagent, Anti-k (Murine Monoclonal)
BL 125233/0Blood Grouping Reagent, Anti-Le a (Murine Monoclonal)
BL 125213/0Blood Grouping Reagent, Anti-P 1 (Murine Monoclonal)
BL 125216/0Blood Grouping Reagent, Anti-S (Monoclonal)
BL 125217/0Blood Grouping Reagent, Anti-Jkb (Monoclonal)
BL 125222/0Blood Grouping Reagent, Anti-D (Monoclonal) (IgM)
BL 125223/0Blood Grouping Reagent, Anti-D (Monoclonal Blend)
BL 125226/0Blood Grouping Reagent, Anti-C (Monoclonal)
BL 125227/0Blood Grouping Reagent, Anti-c ((Monoclonal)
BL 125228/0Blood Grouping Reagent, Anti-E ((Monoclonal)
BL 125229/0Blood Grouping Reagent, Anti-e ((Monoclonal)
BL 125231/0Blood Grouping Reagent, Anti-Jka ((Monoclonal)
BL 125207/0Reagent Red Blood Cells
BL 125215/0Anti-Human Globulin
BL 125242/0Anti-Human Globulin (Rabbit/Murine Monoclonal)


Introduction: Biotest AG applied for Biological License Applications (BLAs) for Blood Grouping Reagents and Anti-Human Globulin.

Discussion: The italicized texts are the summary of the sponsor. The following issues were discussed:

FDA received a phone call from Biotest’s representative, --------------------, on January 18, 2008. The italicized texts are the summary of the sponsor’s issues. The following issues were discussed:

  1. Biotest representative informed FDA that Diagast does not have samples and lot release ready for submission to CBER. Diagast is planning to have an internal meeting to decide when Blood Grouping Reagents lots and Lot Release Protocols will be available, she further stated that it would probably be second week of February 2008.
  2. Biotest representative also informed FDA ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------.
FDA acknowledged the sponsor’s issues


Prepared by Najma Khan on January 18, 2008



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