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Memorandum: Recommendation to Waive Pre-Approval Inspection - Seraclone Blood Grouping Reagent Anti-Fya (Monoclonal)

MEMORANDUM: Recommendation to Waive Pre-Approval Inspection

Date:           July 29, 2008
From:           Marion Michaelis, Reviewer, OCBQ/DMPQ/MRB II, HFM-676
To:              Administrative Bundled File, Biotest AG (LIC #1702):

Products for use on the Tango Automated Blood Group Analyzer

(STN) Biological Products Cell Line(s) Strip Proprietary Name
BL 125097/10Blood Grouping Reagent, Anti-D (Monoclonal)(IgM)
(Formulated for Automated Testing)
BS226
Component of
Erytype S Rh+K
Blood Grouping Reagent, Anti-D (Monoclonal)(IgM)
(Formulated for Automated Testing)
BS232
Component of
Erytype S Rh+K
BL 125206/0Blood Grouping Reagent, Anti-C (Monoclonal)
(Formulated for Automated Testing)
MS24/P3x25513G8
Component of
Erytype S Rh+K
BL 125202/0Blood Grouping Reagent, Anti-E (Monoclonal)
(Formulated for Automated Testing)
MS260/MS12
Component of
Erytype S Rh+K
BL 125205/0Blood Grouping Reagent, Anti-c (Monoclonal)
(Formulated for Automated Testing)
MS33
Component of
Erytype S Rh+K
BL 125203/0Blood Grouping Reagent, Anti-e (Monoclonal)
(Formulated for Automated Testing)
MS16/MS21/ MS63
Component of
Erytype S Rh+K
BL 125204/0Blood Grouping Reagent, Anti-K (Monoclonal)
(Formulated for Automated Testing)
MS56
Component of
Erytype S Rh+K

NOTE- Erytype S are strip wells (eight wells per strip) containing: Anti-D, Anti-D, Anti-C, Anti-c, Anti-E, Anti-e and Anti-K+ Neg Cont

BL 125208/0Reagent Red Blood Cells For Use in Automated SystemsCell Line(s)
Erytypecell A 1 and BN/A
Biotestcell Pool; Biotestcell 1, 2; Biotestcell 3N/A
Biotestcell I8; Biotestcell I11N/A
BL 125218/0Blood Grouping Reagent Anti-D (Monoclonal) (IgG Blend)BS221/H4111B7

Seraclone- Liquid BGR for manual tube testing :

(STN)Biological ProductsCell Line(s)
BL 125222/0Blood Grouping Reagent, Anti-D (Monoclonal) (IgM)BS226
BL 125223/0Blood Grouping Reagent, Anti-D (Monoclonal Blend)BS232/BS221/H4111B7
BL 125226/0Blood Grouping Reagent, Anti-C (Monoclonal)MS24
BL 125227/0Blood Grouping Reagent, Anti-c (Monoclonal)MS33
BL 125228/0Blood Grouping Reagent, Anti-E (Monoclonal)MS12/MS260
BL 125229/0Blood Grouping Reagent, Anti-e (Monoclonal)MS16/MS21/MS63
BL 125212/0Blood Grouping Reagent, Anti-Fy a (Monoclonal)GD-FYA-02
BL 125214/0Blood Grouping Reagent, Anti-s (Monoclonal)P3YAN3
BL 125216/0Blood Grouping Reagent, Anti-S (Monoclonal)MS94
BL 125217/0Blood Grouping Reagent, Anti-Jk b (Monoclonal)MS8
BL 125231/0Blood Grouping Reagent, Anti-Jk a (Monoclonal)MS15
BL 125219/0Blood Grouping Reagent, Anti-A (Murine Monoclonal)A003
BL 125220/0Blood Grouping Reagent, Anti-B (Murine Monoclonal)B005
BL 125221/0Blood Grouping Reagent, Anti-A,B (Murine Monoclonal)BS63 and BS85
BL 125224/0Blood Grouping Reagent, Anti-M (Murine Monoclonal)BS57
BL 125225/0Blood Grouping Reagent, Anti-N (Murine Monoclonal)BS41
BL 125230/0Blood Grouping Reagent, Anti-K (Monoclonal)MS56
BL 125232/0Blood Grouping Reagent, Anti-k (Murine Monoclonal)Lk1
BL 125233/0Blood Grouping Reagent, Anti-Le a (Murine Monoclonal)LEA2
BL 125213/0Blood Grouping Reagent, Anti- P 1 (Murine Monoclonal)650

Other Reagents for Manual Tubes Testing

(STN) Anti-Human Globulin Cell Line(s) 
BL 125242/0Anti-Human Globulin (Rabbit/Murine Monoclonal)BRIC-8
BL 125215/0Anti-Human GlobulinN/A
BL125098/8 Anti-Human Globulin (Formulated for Automated Testing)N/A 
(STN) Reagent Red Blood Cells Cell Line(s) 
BL 125207/0Biotestcell A 1 and BN/A
Biotestcell A 2N/A
Biotestcell Pool; Biotestcell 1, 2; Biotestcell 3N/A
Biotestcell I8; Biotestcell I11N/A
Applicant:Biotest AG, Dreieich, Germany location.
Products:See above bundled file listing.
Through:Chiang Syin, Ph.D., Branch Chief, OCBQ/DMPQ/MRB II, HFM-676

Concurrent Clearance Routing

________________________________________________________________
John A. Eltermann, Jr., R.Ph., M.S.                                                 DateCONCUR
Director, Division of Manufacturing and Product Quality, HFM-670
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research 
________
DO NOT CONCUR
________________________________________________________________
Elizabeth Callaghan                                                                         DateCONCUR
Acting Director, Division of Hematology, HFM-370
Office of Blood Research and Review
Center for Biologics Evaluation and Research
________
DO NOT CONCUR

Summary

We recommend waiver of the pre-approval inspection, BLAs and BLS for Biotest AG, for manufacturing multiple new Blood Grouping Reagents, Anti-Human Globulin, and Reagent Red Blood Cells (specified above).

Brief History

Biotest AG, U.S. License 1702, Dreieich, Germany, submitted a bundle consisting of 30 new BLAs and 2 BLSs in September 2006 (see above). Biotest is currently licensed to manufacture several Erytype S Blood Grouping Reagents are for use on the TANGO Automated Blood Bank System. The purpose of this submission is to obtain approval for additional monoclonal antibodies as components of Erytype S plates, to update the CMC with information related to sublotting and testing of bulk antibodies, and to obtain approval for a complete line of liquid reagents for use in manual immunohematology tube tests.

This bundle is a companion submission to 4 BLAs for Blood Grouping Reagents (Monoclonal)(For Further Manufacturing Use)(FFMU) submitted by DIAGAST, U.S. License 1744; and 10 BLSs and 2 BLAs for Blood Grouping Reagents (Monoclonal)(For Further Manufacturing Use)(FFMU)and Anti-Human Globulin (Murine Monoclonal)(For Further Manufacturing Use)(FFMU) submitted by Millipore (Celliance) U.S. License 1721. The BLAs/BLSs were submitted by DIAGAST and Millipore in September 2006.

Description of Change:

  • BLAs  for manufacturing new Blood Grouping Reagents, Anti-Human Globulin, and Reagent Red Blood Cells (specified above) and associated process and manufacturing changes to previously licensed BGR’s.

Basis for the Waiver:

This waiver is based on criteria outlined in Center wide SOPP 8410 “Determining When Pre-Licensing/Pre-Approval Inspections are Necessary.”  As stated in that SOPP, it is CBER’s policy that a pre-license or pre-approval inspection will generally be necessary for an application if any of the following criteria in bold are met:

  • The facility does not hold an active US license.

    Biotest AG, Dreieich, Germany does hold U.S. license No. 1702.
     
  • The FDA has not inspected the facility in the last two years.

    This facility ( Dreieich, Germany) in the last two years was inspected by:
  1. The first inspection was conducted by Team Biologics (Jacqueline Diaz Albertini) during the time period of 19-28 September 2006 and was a GMP inspection done as part of the Team Biologics work-plan for FY 2006.
     
  2. The second inspection was conducted by CBER (Susan Yu and Joanne Pryzbylik) during the week of June 28 through July 6, 2004 and was a Pre-Licensing Inspection (PLI) for the manufacture of Blood Grouping Reagents (BGR) and Anti-Human Globulin (AHG) for use on the TANGO, an automated blood bank analyzer.
  • The previous inspection(s) revealed significant GMP violations in areas related to the processes in the submission (similar processes) or systemic problems, such as QC/QA oversight.
  1. The inspection in September 2006 was classified VAI. The GMP inspection was done as part of the Team Biologics work-plan for FY 2006.
     
  2. The inspection in June-July 2004 was classified VAI. The PLI inspection was conducted for the manufacture of Blood Grouping Reagents (BGR) and Anti-Human Globulin (AHG) for use on the TANGO, an automated blood bank analyzer.
  • The establishment is performing significant manufacturing step(s) in new (unlicensed) areas using different equipment (representing a process change).  This would include areas that are currently dedicated areas that have not been approved as multi-product facilities/buildings/areas.

    All areas used for the manufacturing are licensed areas.
     
  • The manufacturing process is sufficiently different (new production methods), specialized equipment or facilities) from that of other approved products produced by the establishment.

    The production process is similar to other immunohematology reagents and systems for blood grouping, phenotyping, and antibody screening products produced at the facility.

    Waiver Recommendation:

    Based on the information provided in the BLA and related correspondence supporting the overall compliance status of the license holder, the review committee recommends waiving the pre-approval inspection for the facility changes associated with these supplements.
_____________________________ 07/29/08_ 
Marion Michaelis, HFM-676Date
Reviewer, DMPQ 

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