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Vaccines, Blood & Biologics

Review Memorandum - Biotest AG, License Number 1702 (6/30/2008) - Seraclone Blood Grouping Reagent Anti-S (Monoclonal)

Date: June 30, 2008

To: File STN 125097/10, 125098/8, 125202/0, 125203/0, 125204/0, 125205/0, 125206/0, 125207/0, 125208/0, 125212/0, 125213/0, 125214/0, 125215/0, 125216/0, 125217/0, 125218/0, 125219/0, 125220/0, 125221/0, 125222/0, 125223/0, 125224/0, 125225/0, 125226/0, 125227/0, 125228/0, 125229/0, 125230/0, 125231/0, 125232/0, 125233/0, 125242/0

From: Chiang Syin, Ph.D., Chief, DMPQ, MRB II, HFM-676

Through: John A. Eltermann, Jr., Director, DMPQ, HFM-670

Subject: Review Memorandum – Biotest AG, license number 1702. Response (submitted November 30, 2007) to our CR letter (issued July 30, 2007).


The DMPQ reviewer, George Gentile, has left for a position in the Immediate Office of CBER Director in 2007. He stated on several occasions since his departure from DMPQ that Biotest has addressed all his CR questions in their November 30, 2007 response. I've drafted this memo based on his verbal comment to close out this submission.

Action Recommendation

Approval. The firm has satisfactorily addressed DMPQ comments within the Complete Response (CR) letter dated 7/30/2007.

Manufacturer's response to CR comments

  1. Please define and specify the range of room temperature in the Standard Operating Procedures. Reference is only made to “RT”.
Biotest defines room temperature as -----------.
  1. The Description of the Container Closure system states that the potency data provides evidence that there are no adverse effects, nor interfering substances that leech out of the container/stopper system during the prolonged storage interval. Please provide an explanation of how no traces of escaped reagent is determined.
Biotest stated that the container closure integrity testing included --------------------------------------------------------------------------------------------------------------. Results of the potency, pH and protein testing were within the specifications at all time points.
  1. The submission includes transport stability data that was simulated. Biotest AG should design and perform a shipping study that validates the transport of the product from the manufacturing facility in Germany to the United States end-user.
Biotest evaluated -- shipments from Germany to the U.S. using -------------------- instead of the packaging material that have been in use for licensed products since 2005. The results demonstrated that the -------------- is capable of maintaining the temperature of the package contents between ----------------. As a result of this evaluation, Biotest will perform a new shipping study and submitted the protocol for the transport validation of diagnostic products for overseas shipment. Biotest USA will perform a second shipping study to validate the shipment of the products from Biotest USA to the customer. Biotest submitted the shipping study protocols.
  1. Please provide your process for revalidation to establish ongoing evidence that all specific processes will consistently produce a product meeting its pre-determined specifications and quality characteristics.
Biotest utilizes statistical analysis, trending of relevant process parameters and regular review of data to assure the production of product that consistently meets their pre-determined specifications and quality characteristics. Biotest referenced the SOPs pertaining to revalidation.
  1. Please provide your process for Continuous Environmental Monitoring to demonstrate that environmental quality is consistently within specified levels.

    Biotest provided a procedure for Continuous Environmental Monitoring with specific room classification indicated.

  2. Operational Qualifications were not submitted with the ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.

    Biotest provided adequate response in submitting a summary of the OQ report.

  3. An additional package integrity/stability testing on ---------------------------------------------------------------------------------- is currently in progress. Biotest AG should submit the data/results at the completion of the study.

    Biotest states that the study is ongoing. A report will be submitted upon completion.

  4. An additional study on -------------------------------------------- is currently in progress for package integrity and stability. Biotest AG should submit the data/results at the completion of the study.
Biotest states that the study is ongoing. A report will be submitted upon completion.

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