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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation - Hizentra, January 20, 2010

Submission Type: BLA    Submission ID: 125350/0    Office: OBRR

Product:
Immune Globulin Subcutaneous (Human), 20% Liquid

Applicant:
CSL Behring AG

Telecon Date/Time: 20-Jan-2010 10:00 AM        Initiated by FDA? Yes

Communication Categorie(s):
1. Information Request

Author: SARAH TANKSLEY

Telecon Summary:
DMPQ information request

FDA Participants: Sarah Tanksley

Non-FDA Participants:

Christoph Zahnd, Head of Engineering, E&S
Rainer Kraus, Head of Qualification, E&S
Michel Baur, Head of Quality Control, QM
Jonathan Imhof, Head of Validation, QM
Roland Portmann, Head of Environmental Monitoring, QM
Arnold Nigsch, Head of IgPro10/IgPro20 Manufacturing, PRO
Beat Wanner, Head of Aseptic Filling, PRO
Andreas Wicki, Head of Final Product Manufacturing, PRO
Martin Hobi, Head of Transport & Distribution, Logistics
Florian Lüders, Regulatory Affairs Manager, R&D
Dominique Schaller, Regulatory Affairs Manager, R&D
Urs Meyer, Head of Product Licensing, R&D

Paula Hines, Sr. Manager, Regulatory Affairs

Trans-BLA Group: No
Telecon Body:

I asked for details of the CCIT test procedure for the IgPro20 container closure presentation because only a generic SOP was given in the BLA.  The firm briefly described the --------(b)(4)------ test they perform.  -------------------(b)(4)-----------------     ----------------------------------------------(b)(4)---------------------------------------------------     -----------------------------------------------.  The vials are visually inspected.  The contaminated vials ---------(b)(4)----------. 

I asked for the validation of this method, and the sensitivity. The firm does not have the information and as of right now, it appears they have not validated the ------(b)(4)-------- method.  The firm does not perform any other test for CCIT, such as dye leak.  The firm contends that the initial -------(b)(4)------ test, the successful media fill, and the sterility results from the stability data demonstrate that their container closure is adequate. 

I asked for the results of the latest media fill using this container presentation.  The firm responded that the results from the last media fill were in the BLA.  The firm has not performed an additional media fill with this presentation in two years.  When asked why, the firm responded that once the product is approved, they will add the container closure system to the repertoire of those tested during the routine -(b)(4)- media fills.

The firm agreed to provide me as much information as they have regarding the CCIT       -------(b)(4)------- ingress test.

I asked about the filter used for the -------(b)(4)------- on the filling line.  The -(b)(4)- is a new process for IgPro20.  The firm did not know what kind of filter is used for the           --(b)(4)--.  The filter is ---------------------------------(b)(4)------------------------------------, but filter validation studies were accepted from the vendor.  I advised the firm that FDA would normally expect the firm to have performed their own study or at least referenced a DMF for the filter on a filling line.  I asked for information regarding the type of filter, and the integrity testing performed on the filter.

I reviewed the shipping validation with the firm.  The firm explained that after performing a risk assessment they determined that the shipping validation performed for IgPro10 applies to IgPro20, because the packaging is the same.  Also, the stopper neck is identical for the vials and closures are very similar.  I told the firm that I found this acceptable.

I also asked for clarification on the visual inspection process. The firm uses manual visual inspection, and the defects and parameters are exactly the same as for IgPro10.  A risk assessment was performed and it was determined that the visual inspection qualification would not need to be repeated for IgPro20.