Record of Telephone Conversation, July 31, 2012 - HPC, Cord Blood BLA 125432
HPC, Cord Blood
LifeSouth Community Blood Centers, Inc.
Telecon Date/Time: 31-Jul-2012 02:00 PM Initiated by FDA? Yes
Telephone Number: -----(b)(4)-------
1. Information Request
Author: CANDACE JARVIS
Additional information requested regarding manufacturing capacity, product labeling (ISBT-28) and stability data issues.
FDA Participants: Grace M.B. Deneke, CSO (CBER/OCBQ/DMPQ)
Marion Michaelis, Team Leader (CBER/OCBQ/DMPQ)
Mohammad Heidaran, Ph.D., Biologist (CBER/OCTGT/DCGT)
Eric Dollins, Ph.D., Biologist (CBER/OCTGT/DCGT)
Loan Nguyen, Ph.D., Regulatory Reviewer (OCBQ/DCM/APLB)
Candace Jarvis, RPM (CBER/OCTGT)
Non-FDA Participants: Jill Evans, Vice President of Quality
Nancy Eckert (CEO)
Kathleen Sazama (Medical Officer)
Lori Masingil (Technical Communications Manager)
Tammy Lawson, (Validation Coordinator)
Amy Lambert, (Manager Cellular Therapies)
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
FDA requested a brief teleconference with the sponsor to discuss items regarding product labeling, stability data expiration and manufacturing capacity.
FDA wanted to clarify with the sponsor that they are indeed requesting barcode exemption and that they would like to use the ISBT-128 labeling requirements. The sponsor stated that yes, they are requesting barcode exemption and that they are going to comply with ISBT-128 requirements for labeling. FDA replied that there would be later discussions regarding their exemption request. FDA noted that the sponsor’s partial container label that was submitted in their application did not have a product code and asked if they could include that on the label as it and the unit identifier are required components of the product label. The sponsor replied that they will add the product code to the label and asked if the label needed to be scanable. FDA replied yes that the label needed to be scanable. With regard to the package label, FDA noted that the label doesn’t look to be ISBT-128 compliant and asked if that was the sponsor’s intention. The sponsor replied yes that the package label will be ISBT-128 compliant and will update to reflect such.
FDA asked the sponsor to define the expiration date for the product as it stands now with manufacturing. The sponsor stated that they have a 4 month expiration date and a 2 hour expiration date post thaw that they can substantiate right now. FDA stated that they will need to have supporting data to reflect that information. The sponsor stated that they will submit the information they have regarding the 4 month expiration date and will submit the data from their 6 month expiration in September. FDA stated that they would like to review the information that they have collected to establish the initial expiration date for the product. Sponsor may extend the expiration date going forward.
FDA requested clarification on the sponsor’s maximum capacity and overall workflow for the number of products and personnel during the manufacturing process. FDA discussed with the sponsor their previous statement that their maximum capacity was (b)(4) but then stated that during the time of inspection they would only be able to manufacture (b)4 units. The sponsor stated that their maximum workload currently is(b)4 units processed a day but they have the capacity for processing (b)(4). The firm indicated they mostly process (b)(4) units a day, but at times it could be (b)4. They stated that in the future they anticipate manufacturing up to --(b)(4)-- a day once they get licensed and there could possibly be more units coming in. The sponsor also stated that they have the personnel to manufacture –(b)(4)-- concurrently but often the manufacturing is performed consecutively. FDA stated that the sponsor’s process validation should simulate the worst case condition which in this case would be the concurrent manufacturing. The sponsor stated that the process validation (media simulation) submitted does not reflect the concurrent manufacturing, therefore they will repeat the study.
FDA asked the sponsor what was their expected time line to respond to the deficiencies outlined in the July 16, 2010 filing letter. The sponsor responded that they anticipate submitted responses within the next 3 weeks and asked if they were to send the responses in as an amendment. FDA replied yes.