January 13, 2012 Approval Letter - ALBAcyte

Our STN: BL 125337/0
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 Reagent Red Blood Cells effective this date. This includes:

Reagent Red Blood Cells	Indication
A1	ABO reverse grouping of patient or donor serum/plasma
A2	ABO reverse grouping of patient or donor serum/plasma
B	ABO reverse grouping of patient or donor serum/plasma
O rr	ABO reverse grouping of patient or donor serum/plasma
Antibody screening panel	The Reagent Red Blood Cells are intended for the detection of unexpected red blood cell antibodies in patient blood samples
Antibody identification panel	The Reagent Red Blood Cells are intended for the identification of unexpected red blood cell antibodies in blood samples
Antibody identification panel (Papain-treated)	The Reagent Red Blood Cells are intended for the identification of unexpected red blood cell antibodies in blood samples

You are hereby authorized to introduce or deliver for introduction into interstate commerce, Reagent Red Blood Cells under your existing Department of Health and Human Services U.S. License No. 1807.

Under this authorization, you are approved to manufacture Reagent Red Blood Cells at your facility in Edinburgh, Scotland, UK. You may label your product with the proprietary name ALBAcyte ® and will be marketed in the following fill sizes:

Reagent Red Blood Cells	Fill Size
A1	10 mL
A2	10 mL
B	10 mL
O rr	10 mL
Antibody screening panel	10 mL
Antibody identification panel	5 mL
Antibody identification panel (Papain-treated)	5mL

We did not refer your application to the Blood Products Advisory Committee because our review of information submitted in your BLA, including the clinical 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 Reagent Red Blood Cells shall be no more than 63 days from the date of donation, or, no more than 50 days from the date of manufacture when stored at 2 – 8 °C. The date of manufacture shall be defined as the date of the initial processing of the liquid or (previously frozen) thawed donation.

You currently are not required to submit samples of future lots of Reagent Red Blood Cells 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.

Please submit all final printed labeling at the time of use and include implementation information on Form FDA 356h and Form FDA 2567 as appropriate. Please provide a PDF electronic copy as well as three original paper copies for circulars and other labels.

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, MD 20852-1448.

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, Maryland 20847-3002.

We acknowledge your written commitments as described in your letter of January 11, 2012 as outlined below:

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

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The information to fulfill this PMC will be submitted as a Final Study Report by May 31, 2012.

W e request that you submit information concerning nonclinical and chemistry, manufacturing, and control postmarketing commitments and final reports to your BLA, STN BL 125337/0.

For each postmarketing commitment not subject to the reporting requirements of 21 CFR 610.70, 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, M.D.

Director

Office of Blood Research and Review
Center for Biologics
Evaluation and Research