(System Info - 118078 TULL LORI 01/22/2010 14:42:21 TULL)
RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125197/0 Office: OCTGT
Telecon Date/Time: 21-Jan-2010 02:00 PM Initiated by FDA? Yes
1. Information Request
Author: THOMAS FINN
Discuss process capacity at the NJ facility
FDA Participants: None
Non-FDA Participants: None
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
1-21-10 Telecon to discuss process capacity at NJ facility
Mary Coon, Quality
Michael Covington, Quality
Heidi Hagen, Operations
Bill Montieth, GM New Jersey
Georgeta Puscalau, Quality
Connie Spooner, Regulatory
Elizabeth Smith, Regulatory
Dendreon requested a telecon to go over their intended manufacturing capacity. The FDA had previously requested more information about how much product would be made in the facility and what a typical production week would look like. No information had been provided either in the BLA, the BLA resubmission, or any of the BLA amendments to date. In response to the Agency’s clarification on manufacturing capacity Dendreon had provided a summary diagram representing a full week’s worth of manufacturing. On that figure ----------------(b)(4)-------------------------------------------------------------------------------------------. Dendreon also provided an additional 5 page document that included tables of theoretical maximums and intended maximum capacities. Those numbers were consistent with the previous figure.
During the telecon Dendreon described how they would reserve (b)(4) of their manufacturing capacity from the theoretical maximum to allow for things like patient rescheduling and manufacturing problems/delays. A discussion of the various figures and tables took place. The Agency then asked about what is the maximum throughput per day per workstation would take place. The sponsor responded by saying maximum ---------(b)(4)------------------- but then they went on to say that they would never process at that level because it would be a force fit. However, on the color figure they provided a week or so ago and then again on Fig 2 (page 2) of the document they sent last night they listed for -------------------(b)(4)--------------- as part of their intended capacity.
They go on to say they will purposely target (b)(4) of that. Fig 2 of the 5 page document shows that up to ------(b)(4)--------------- lots per workstation per week is their intended operating maximum. That figure still lists (b)(4) lots ------(b)(4)------- on ----(b)(4)-----so on the busiest day of the week they will be operating at the theoretical maximum workstation capacity for that day. Dendreon does not normally consider production on a (b)(4) basis but on a (b)(4) basis- this may be because on any one day an -(b)(4)- number of -----(b)(4)------ lots are generated, but over the course of a week it evens out.
The discussion continued by re-examining their capacity study. Although they did not generate that level of throughput in any one day, if you fit all the b(4) day production that was executed it into a single (b)(4) hour shift, then you could say they were processing ------(b)(4)----- per workstation per day. Dendreon also confirmed that the targeted capacity takes into account all the processing times, set up times, change over procedures, line clearance, monitoring etc.
Another question raised by FDA was whether the schedule factors in normal rescheduling patients. If during week ------(b)(4)------- lots are made then according to clinical protocol (b)(4) weeks later the next lot needs to be generated. That would be another (b)(4) total lots produced for the same patients, which would occupy all of a full week’s capacity so no new patients could be scheduled. Dendreon first clarified that all the scheduling for the 3 leukapheresis and 3 infusions is done at the same time so the full manufacturing calendar for that patient is known from the start. The scheduling of new and existing patients is staggered so that during a given week 9 of the patients are new and 2 are reschedules.
The last point raised was how the QC testing overlaps with the manufacturing. The capacity study provided in BLA amendment 17 included QC testing, but it was not indicated on the diagram or described in the text. The more recent diagrams and tables Dendreon provided also did not indicate QC testing. Dendreon was asked to overlay QC testing with the GMP manufacturing so that a more complete picture was provided. Dendreon agreed to provide such a diagram.
Dendreon had no questions for the FDA.