

Record of Telephone Conversation - Provenge, January 21, 2010


 
(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

Product:
 Sipuleucel-T

Applicant:
 Dendreon Corporation

Telecon Date/Time: 21-Jan-2010 02:00 PM        Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):
 1. Information Request

 Author: THOMAS FINN

Telecon Summary:
 Discuss process capacity at the NJ facility

FDA Participants: None

Non-FDA Participants: None

Trans-BLA Group: No

 Related STNs: None

Related PMCs: None

Telecon Body:
 1-21-10 Telecon to discuss process capacity at NJ facility   
 2:00 PM

FDA participants:
 Gang Wang
 Randa Melham
 Thomas Finn
 Steven Oh
 Barbara Wilimczky

Dendreon:
 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.
 
