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October 16, 2009 Approval Letter - ALBAclone (Alba Bioscience Limited)
October 16, 2009
Alba Bioscience Limited
Attention: Mr. Ian Carmichael
21 Ellen's Glen Road, Liberton
Edinburgh EH17 7QT
Dear Mr. Carmichael:
We are issuing Department of Health and Human Services U.S. License No. 1807 to Alba Bioscience Limited, Edinburgh, U.K., under the provisions of section 351(a) of the Public Health Service Act controlling the manufacture and sale of biological products. The license authorizes you to introduce or deliver for introduction into interstate commerce, those products for which your company has demonstrated compliance with establishment and product standards.
Under this license, you are authorized to manufacture the Blood Grouping Reagents listed below. These products are indicated for the in vitro detection and identification of human blood group antigens by direct agglutination.
|STN||Name of Biological Product||Cell Line|
|BL 125301/0||Blood Grouping Reagent, Anti-A (Murine Monoclonal)||LA2|
|BL 125302/0||Blood Grouping Reagent, Anti-B (Murine Monoclonal)||LB3|
|BL 125303/0||Blood Grouping Reagent, Anti-A,B (Murine Monoclonal)||LA2/LB3/ES15|
|BL 125304/0||Blood Grouping Reagent, Anti-D (Monoclonal) (IgM)||LDM1|
|BL 125304/0||Blood Grouping Reagent, Anti-D (Monoclonal)(IgM)||LDM3|
|BL 125305/0||Blood Grouping Reagent, Anti-E (Monoclonal)||DEM1|
|BL 125306/0||Blood Grouping Reagent, Anti-c (Monoclonal)||H48|
|BL 125307/0||Blood Grouping Reagent, Anti-k (Murine Monoclonal)||LKL1|
|BL 125308/0||Blood Grouping Reagent, Anti-M (Murine Monoclonal)||LM1|
|BL 125309/0||Blood Grouping Reagent, Anti-N (Murine Monoclonal)||LN3|
|BL 125310/0||Blood Grouping Reagent, Anti-Lea (Murine Monoclonal)||LEA2|
|BL 125311/0||Blood Grouping Reagent, Anti-Leb (Murine Monoclonal)||LEB2|
|BL 125312/0||Blood Grouping Reagent, Anti-Lub (Murine Monoclonal)||LU2|
|BL 125313/0||Blood Grouping Reagent, Anti-D (Monoclonal)(IgM Blend)||LDM1/ESD1-M|
|BL 125314/0||Blood Grouping Reagent, Anti-D (Monoclonal Blend)||LDM3/ESD1|
Under this license, you are approved to manufacture Blood Grouping Reagents at your facility in Edinburgh, United Kingdom. You may label your products with the proprietary name ALBAclone® and will market them in 2 mL, 5 mL, or 10 mL screw-cap glass dropper vials, as specified in your applications.
We did not refer your application to the Blood Products Advisory Committee because the mechanisms of manufacturing monoclonal reagents and their use in hemagglutination testing in immunohematology are well-understood. Our review of information submitted in your BLA, including the study design and trial results, did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.
The dating period for the ALBAclone® Blood Grouping Reagents shall be 24 months from the date of manufacture when stored at 2 - 8 °C. The date of manufacture shall be defined as the date of the final filtration of the bulk product. Following the final filtration, no reprocessing is allowed without prior approval from the Agency.
Please submit final container samples of the product in final containers together with protocols showing results of all applicable tests. You may not distribute any lots of product until you receive a notification of release from the Director, Center for Biologic Evaluation and Research (CBER).
You must submit information to your biologics license application for our review and written approval under 21 CFR 601.12 for any changes in the manufacturing, testing, packaging or labeling of Blood Grouping Reagents, or in the manufacturing facilities.
You must submit reports of biological product deviations under 21 CFR 600.14. You promptly should identify and investigate all manufacturing deviations, including those associated with processing, testing, packing, labeling, storage, holding and distribution. If the deviation involves a distributed product, may affect the safety, purity, or potency of the product, and meets the other criteria in the regulation, you must submit a report on Form FDA-3486 to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Rockville, MD 20852-1448.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h and FDA Form 2567 as appropriate. Please provide a PDF-format electronic copy as well as original paper copies (three for circulars and other labels).
In addition, you may wish to submit two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. [FOR DEVICES USE: Two draft copies of the proposed introductory promotional labeling may be voluntarily submitted for advisory comment with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville, MD 20852-1448.]
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have submitted data to support such claims to us and had them approved.
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, PO Box 3002, Rockville, Maryland 20847-3002.
Mary A. Malarkey
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics Evaluation and Research