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Vaccines, Blood & Biologics

Filing Meeting Minutes, June 21, 2011 - HPC Cord Blood


Filing  Meeting Minutes
Applicant:       ClinImmune
BLA #:            BLA 125391
Product:          Hematopoietic stem/progenitor cells, cord (HPC-C)
Review Team:

Product Reviewer/Chair
Yong Fan-manufacture and process validations
301 827 6038
Lilia Bi-Testing and validations
301 827 4016
Safa Karandish-DE
301 827 2477
Fatima Abbasi-Flow
Joydeep Ghosh-Sterility validation
Pharm/Tox Reviewer
Atm S. Hoque
301 827 9071
Clinical Reviewer
Rachel Witten
301 827 9134
Ramani Sista
301 827 5152
Labeling Reviewer
Loan Nguyen/Lisa Stockbridge
301 827 6333
DMPQ Reviewer
Mohammad Heidaran/Marion Michaelis and Sean Belouin
301 827 7186
BIMO Reviewer
Dennis Cato
301 827 2588
Statistics Reviewer
Chunrong Cheng
301 827 6053

Filing Letter Action/Comments: COB, Friday, June 24, 2011
60 day: July 3, 2011 (7/1because 7/3 is Sunday)
74 day/Filing Letter: Friday, July 15, 2011
Mid-cycle Review Meeting: September 30, 2011-Draft review ready
Team Meetings: August 10 and November 16, 2011
Wrap up Meeting: January 5, 2012
Product Filling Issues:
DE (Safa)-Donor ID testing validation data was not provided
Manufacture (Yong)-No filling issues
Testing (Lilia)-Viability, HLA, ABO/Rh and (b)(4) validation data were not provided
(b)(4) (Fatima)-CD34 validation data was not provided
Sterility (Joy)-Validation submitted but deficient, not a filling issue
GMP/Facility (Mo and Marion)-No filling issues
Pre-clinical (Shamsul)-No filling issues
Clinical (Rachel)-Safety data was not submitted
Labeling (Loan)-No filling issues
Discussion of filling issues:
Two t-cons with ClinImmune were held to request the missing elements. ClinImmune agreed to submit everything except donor ID testing validation data because the contract lab is not fully cooperating with this effort.
OCTGT management indicated that we need to prepare for RTF if we don’t receive the requested validation data.
Discussion of other issues:
  1. The NAT testing wasn’t required until August 2007, therefore OCTGT management indicated that the units were not tested using NAT are not licensable. This is not a public knowledge yet. Further discussion is required.
  1. ClinImmune intends to license the units that have been manufactured from July 2005 onward, however, most of the validations were not completed until 2010 and some of them are retrospective validations. The review team needs to decide what can be licensed based on the validations and GMP compliance.
  1. There are some GMP issues which may be filling issues if we consider licensing the units before 2009/2010. We need to discuss this with ClinImmune and agree on what can be licensed.
Action Items:
1.                  Ramani will prepare both filling and RTF letters for the time being.
2.                  Reviewers need to send concurred RTF comments to Ramani by Friday, 6/24/11.
3.                  Ramani will schedule a t-con with ClinImmune on Monday to discuss filling issues.
4.                  Stephanie will discuss with legal regarding the Nat testing issue.

Boguang Zhen
Changting Haudenschild
Kimberly Benton
Keith Wonnacott
Donna Przepiorka
Mercedes Serabian
Atm S. Hoque
Stephanie Simek
Wilson Bryan
Lori Tull
Yong Fan
Lilia Bi
Safa Karandish
Fatima Abbasi
Joydeep Ghosh
Rachel Witten
Loan Nguyen
Mohammad Heidaran
Marion Michaelis
Dennis Cato
Chunrong Cheng

Page Last Updated: 06/19/2012
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