Vaccines, Blood & Biologics
Team Meeting 4, November 26, 2012 - HPC, Cord Blood BLA 125432
DATE: November 26, 2012
Time: 12:00 -1:00 PM EST
BLA #: BLA 125432
Product: HPC, Cord Blood
FDA Attendees: Candace Jarvis, Mohammed Heidaran, Juanita Williams-Gould, CHad Burger, Atm S.Hoque, , Stan Lin, , Karoll Cortez, Keith Wonnacott, Lisa Stockbridge, , Joydeep Ghosh, Wilson Bryan, Kimberly Benton, Lillian Ortega, , Fatima Abassi, Eric Dollins, Stephanie Simek, Celia Witten, Mark Borigini, Changting Haudenschild, Raj Puri,
Call in information: -------------(b)(4)------------------------
1. Administrative Updates
- None at this time
2. Review Updates
- Donor screening SOPs need to be revised to provide detail information regarding review of the medical and physical examination records
- Collection validation information not adequate. The applicant has not provided all the data; doable in a short period of time
- The applicant must provide information regarding the assignment of unique donor identification and maintaining linkage between the collected unit and the birth mother; doable in a short period of time
- The applicant must provide analytical specificity and analytical sensitivity for CD34 and nRBC enumeration laboratory validated tests; (higher limit of detection need to be shown); doable in a short period of time
- In regard to ---(b)(4)--- sterility test method validation, the adequacy of the sampling plan for the final product has not been adequately established; sponsor to submit validation plans for preview/comments; need to determine if the sponsor plans to exclude birth mothers on antibiotics.
- Package label is not in compliance with ISBT requiring bar codes
Update: Sponsor plan to fully implement ISBT 128 by 12/30/12
- Request for proprietary name is outstanding
Update: Sponsor plan to submit proprietary name request after approval.
- Revalidation of the Emergency recovery remains to be performed.
b. DMPQ :
- Sponsor states that they are planning renovation of clean rooms on 11/27/12. Not too sure of flooring they are going to use as it is listed as industrial grade clean room flooring from a tile company; however, the owness for their choice of flooring belongs to them. Once renovations are complete, they will need to re-qualify the room.
- Main issue: seems to be executing the qualifying of the cleaning and identifying organisms and growth promotion; they also need to qualify new equipment.
- End of January beginning of February seems to the target for resolving the facility issue
- No new updates
- Sponsor submitted the appropriate HLA matching data, appears to be adequate.
- Created a table showing the number of subjects achieving ANC>500 by day 42 cross classified by HLA match and TNC Dose (X107/kg).
- No new updates
3. Upcoming Dates:
Next team Mtg: January 7, 2013
Completed Review Due: January 17, 2013
Wrap-Up Mtg: February 19, 2013 (Date subject to change)
Labeling Mtg: TBD
4. Other Issues
- Timelines submitted by sponsor-Upper Mgmt discussion needed
- Determination of Major Amendment for outstanding items submitted by sponsor and clock extension option
- Determination of CR letter issuance.
5. Issues/Questions for sponsor discussion
- Inform sponsor that when submitting amendments to the BLA, inspectional findings need to be separated from review related issues.
Update: sponsor informed in 11/28/12 t-con