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Vaccines, Blood & Biologics
Submission Type: Original Application Submission ID: 125335/0 Office: OBRR
Centruroides (Scorpion) Immune F(ab)2 Intravenous (Equine)
Instituto Bioclon, S.A. de C.V.
Telecon Date/Time: 29-JAN-2009 12:00 AM Initiated by FDA? Yes
Author: DEBRA CORDARO
FDA Participants: Nancy Waites, Robert Fisher, Debbie Cordaro
Non-FDA Participants: -------------------(b)(4)---------------
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
FDA indicated the purpose of the call was to determine if information was omitted from the submission or identify where in the submission needed information can be located.
FDA referred the firm to the meeting minutes of April 10, 2008 and December 12, 2008. FDA commented that information we requested during those meetings do not appear to be included in the BLA.
Regarding the water system, Bioclon commented that they will be purchasing --(b)(4)--- water ----(b)(4)----for using in the drug product compounding production. When asked if this purchased water would also be used in the (b)(4) processes, Bioclon indicated they would need to verify this answer and respond to the FDA.
Since it has been stated that the equipment to manufacture this product is used for the production of other IND products, Bioclon will need to specify which pieces of equipment and which rooms are shared.
Bioclon will provide:
1. a list of steps in the manufacturing and indicate which type of water will be used for each step
2. information on their manual cleaning process since it was omitted from the BLA
3. the leak testing procedure
4. the vial with stopper container closure, integrity test validation
5. shipping validation
6. a statement that no computer systems are used
7. batch record validation
8. cleaning agent validation, demonstrating that it is effective against organisms
Bioclon was informed that FDA will provide a complete list of information needed.
Note: The information request was sent February 6, 2009.