Record of Telephone Conversation, March 28, 2014 - Eloctate
 
RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA    Submission ID: 125487/0    Office: OBRR
Product:
Antihemophilic Factor (Recombinant), Fc Fusion protein
Applicant:
Biogen Idec Inc.
Telecon Date/Time: 28-Mar-2014 11:00 AM        Initiated by FDA? Yes
Telephone Number: 18663093684
Communication Categorie(s):
1. Information Request

Author: JIE HE
Telecon Summary:
DMPQ discussed lyophilizer validation issues with the firm
FDA Participants: 
Jie He, Ellen Huang, Destry Sillivan
Non-FDA Participants: 
Biogen Idec
Suzanne Stella, Regulatory Affairs
Elijah Tan, Regulatory Affairs
Mariana Dimitrova, Technical Development
Eliana Clark, Technical Development
Edward Goodreau, Manufacturing Sciences
Alasdair Shepherd, International Quality
Bruce Madsen, Contract Mnufacturing

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

Telecon Body:
FDA requested this telecon to discuss lyophilizer validation studies submitted in Amendment 36.

FDA discussed the empty chamber study results, particularly the –b(4)-------- locations that have failed to meet acceptance criteria.  FDA stated that the Agency expects tight control of shelf temperature during the lyophilizer empty chamber mapping study in order to ensure temperature uniformity throughout the entire lyophilizer chamber during all stages of the lyophilization cycle, and reiterated that the –b(4)- acceptance range from the set point used by –b(4)- in the empty chamber study –b(4)------------- is not normally seen in the industry, and the Agency prefer to see it to be tightened to –b(4)-.  FDA asked Biogen Idec to provide data for –b(4)---------------------------------------- lyophi9lization steps from the technical runs, and also to clarify if only the –b(4)------------ will be used in minimum load at –b(4)------

Biogen Idec and –b(4)--- confirmed that for the lyophilizer minimum loads, only the b(4)  ---------------- will be used.  Biogen Idec agrees to monitor the worst case locations within the lyophilizer during the –b(4)--- requalification for potential –b(4)------------------- from these locations.  Biogen Idec commits to initiating a CAPA to evaluate the –b(4)----- qualification strategy of the b(4) lyophilizer related to the agency expectations to tighten the acceptance criteria.  Biogen Idec agreed to submit these agreements in amendment to the BLA.

Biogen Idec agreed to provide the following additional information regarding the validation study:
1. ---b(4)-----------------------------------------------------------------------------------------------------------------------------------------.
2.---------------b(4)------------------------------------------------------------------------------------------------------------------------------------.
