Record of Telephone Conversation, October 18, 2013 - ALPROLIX

Submission Type: BLA    Submission ID: 125444/0    Office: OBRR
Product:          Coagulation Factor IX (Recombinant), Fc Fusion Protein
Applicant:       Biogen Idec Inc.
Telecon Date/Time: 21-Oct-2013 1:00 pm        Initiated by FDA? Yes

Communication Category:     1. Other - Facility Issues

Author: Edward Thompson
Revised: Ellen Huang

Telecon Summary:     Discussed CCIT issues

FDA Participants: 
Destry Sillivan, MS, OCBQ/DMPQ
Ellen Huang, OCBQ/DMPQ 
Edward Thompson, OBRR

Non-FDA Participants: 
Biogen Idec
Amin Abujoub, VP, Global Quality Control
Eliana Clark, CMC Team Director 
Olivia Henderson, Principal Scientist, Technical Development
Denise Schultz, Associate Director, CMC Regulatory Affairs 
Suzanne Stella, Director, CMC Regulatory Affairs
Sherry Tamura, Senior Manager, Analytical Technology
Andrew Weiskopf, Director, Technical Development

 

Telecon Body:
On October 15, 2013 CBER received additional information regarding container closure integrity test (CCIT) methods in amendment STN 125444/0/37. FDA initiated this teleconference to clarify issues with the CCIT for the vials and syringes.

FDA asked if the firm had any additional CCIT data for the diluent syringes [similar to what the firm submitted for the drug product (DP) vials]. The firm stated that they had sterility data for three lots that were placed on stability and -(b)(4)- lots for release. Besides the CCIT data from -(b)(4)- (where the positive control was -(b)(4)-), the firm did not have additional CCIT data for the diluent syringes. FDA explained that sterility testing can be used as supportive data, but cannot be used as a substitute for CCIT.

FDA noted that in Amendment STN 125444/0/37 the firm --------------(b)(4)----------------------------------------------------------------------------------------------------------------------------

------------------------------------------------------(b)(4)-----------------------------------------------------------------------------------------------------------------------------------------------------------

FDA explained that the CCIT was found acceptable for the DP vials given the large amount of data provided from --(b)(4)--- (where the positive control was -(b)(4)-). FDA clarified that their concerns about CCIT were around the diluent syringes.

FDA asked the firm when they would be able to repeat container closure qualification studies with a validated method capable of detecting breaches -(b)(4)- for the diluent syringes. -----------------------------------------(b)(4)---------------------------------------------------------------

FDA stated that if everything else is approvable in the submission, this could be a PMC in the approval letter. However, if there are other issues, this would be included in the CR letter. The firm stated they understood.
