• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

July 19, 2013 Approval Letter - Anti-A (DAM1, LA2) Murine Monoclonal Igm

Alba Bioscience Limited
Attention:  Mr. John Allan
21 Ellen's Glen Road
Edinburgh  EH17 7QT
United Kingdom

Dear Mr. Allan:

We have approved your biologics license application for the following biological products effective this date:

STN                           Name of Biological Products 
                     


BL125438/0

Blood Grouping Reagent (For Further Manufacturing Use) Anti-A (DAM1) Murine Monoclonal IgM
Blood Grouping Reagent (For Further Manufacturing Use) Anti-A (LA2), Murine Monoclonal IgM

BL125440/0

Blood Grouping Reagent (For Further Manufacturing Use) Anti-c (H48) Human/Murine Monoclonal IgM

You are hereby authorized to introduce or deliver for introduction into interstate commerce, the biological products listed above under your existing Department of Health and Human Services U.S. License No. 1807.  The Blood Grouping Reagents (For Further Manufacturing Use) listed above are indicated for use in the manufacture of in vitro product Blood Grouping Reagents, Anti-A and Anti-c  by Diagnostic Grifols S.A. (Spain) U.S. License No. 1887, under a shared manufacturing arrangement.

Under this authorization, you are approved to manufacture the products listed above at your facility in Edinburgh, United Kingdom.  You may label your products with the names Blood Grouping Reagent(For Further Manufacturing Use) Anti-A (DAM1) Murine Monoclonal IgM, Blood Grouping Reagent (For Further Manufacturing Use) Anti-A (LA2), Murine Monoclonal IgM and Blood Grouping Reagent, (For Further Manufacturing Use), Anti-c (H48) Human/Murine Monoclonal IgM.

We did not refer your application to the Blood Products Advisory committee because our review of information submitted in your BLA, did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.

The dating period for Blood Grouping Reagents Anti-A (Murine Monoclonal)(For Further Manufacturing Use) and Anti-c (Human Monoclonal)(IgM)(For Further Manufacturing Use) shall be 24 months from the date of manufacture when stored at 2-8 °C.  The date of manufacture shall be defined as the last date of pre-fill potency testing. 

You currently are not required to submit samples of future lots of Blood Grouping Reagents, Anti-A (Murine Monoclonal)(For Further Manufacturing Use) and Anti-c (Human Monoclonal) (IgM)(For Further Manufacturing Use) to the Center for Biologics Evaluation and Research (CBER) for release by the Director, CBER, under 21 CFR 610.2.  We will continue to monitor compliance with 21 CFR 610.1 requiring completion of tests for conformity with standards applicable to each product prior to release of each lot.

Two draft copies of the proposed introductory promotional labeling may be voluntarily submitted for advisory comment with a Form FDA 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448.

ADVERSE EVENT REPORTING

You must submit adverse experience reports in accordance with the Medical Device Reporting requirements for medical devices (21 CFR 803) as required by 21 CFR 600.80(k)(2).  Since your product is characterized as a device as well as a biological, submit these reports to the MedWatch System using MedWatch Reporting Form 3500A.  Required reports should be submitted to the Food and Drug Administration, Center for Devices and Radiological Health, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002.

We acknowledge your written commitments as described in your letter of December 5, 2012, March 20, 2013 and July 11, 2013, as outlined below:

Postmarketing Studies not subject to reporting requirements of 21 CFR 601.70.

  1. Alba commits to complete validation of ----------------------------------------------------------------(b)(4)----------------------------------------------------------------------------------.  Alba will submit the results to FDA as a Postmarketing Study Commitment – Final Study Report by December  2013.
  1. Alba commits to complete --------------(b)(4)------------- testing of Anti-A (clone DAM1 and clone LA2) and Anti-c (clone H48) blood grouping reagents FFMU.  Alba will submit the results to FDA as a Postmarketing Study Commitment – Final Study Report by June 30, 2013.  Please provide updated date on this Postmarketing Study Commitment in your written commitment letter.
  1. Supporting documentation should be provided to demonstrate that CCIT has been adequately assessed on the ---(b)(4)--- storage container as discussed in CR response #3; Alba Bioscience Limited commits to provide the requested information on completion of the study, i.e. to coincide with the shelf-life of the product by mid- year 2015.
  1. Supporting documentation should be provided to demonstrate that an effective transportation study was conducted at or simulating seasonal and condition temperature ranges and using the adequate transportation configuration for the monoclonal antibody FFMU that is shipped to Diagnostic Grifols S.A as discussed in CR response #4; Alba Bioscience Limited commits to provide the requested information by December 31, 2013.
  1. Validation data should be provided to demonstrate that an effective ---------(b)(4)--------- Study was conducted for -----------------------------------------------------(b)(4)------------------------------------------------- as discussed in CR response #5.a., #5.c. and #5.d.; Alba Bioscience Limited commits to provide the requested information by December 31, 2013.

We request that you submit information concerning nonclinical and chemistry, manufacturing, and control postmarketing commitments and final reports to both your BLAs, STN BL 125438/0 and STN BL 125440/0.

Please use the following designators to label prominently all submissions, including supplements, relating to these postmarketing study commitments as appropriate:

  • Postmarketing Study Correspondence
  • Postmarketing Study Commitment – Final Study Report
  • Supplement Contains Postmarketing Study Commitment – Final Study Report

For each postmarketing commitment not subject to the reporting requirements of 21 CFR 601.70, you may report the status to FDA as a “PMC Submission – Status Update.”  The status report for each commitment should include:

  • The original schedule for the commitment, and
  • The status of the commitment (i.e., pending, ongoing, delayed, terminated, or submitted).

When you have fulfilled your commitment, submit your final report as PMC Submission – Final Study Report or Supplement Contains Postmarketing Study Commitment – Final Study Report.

Sincerely yours,

 

Jay S. Epstein, MD
Director
Office of Blood Research and Review
Center for Biologics

  Evaluation and Research