
 


Record of Telephone Conversation - Provenge, December 18, 2009


(System Info - 125450 TULL LORI 04/07/2010 12:52:21 TULL)

RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA    Submission ID: 125197/0    Office: OCTGT

Product:
 Sipuleucel-T

Applicant:
 Dendreon Corporation

Telecon Date/Time: 18-Dec-2009 02:00 PM        Initiated by FDA? Yes

Telephone Number: 888-924-9240       #--b(2)-----

Communication Categorie(s):
 1. Information Request

 Author: THOMAS FINN

Telecon Summary:
 Discussion of manufacturing at NJ facility

FDA Participants: Tom Finn
 Gang Wang
 Steven Oh

Non-FDA Participants: Mary Coon, VP Quality
 Michael Covington, Sr. Director, Quality Assurance
 Heidi Hagen, SVP Operations
 Bill Montieth, VP and General Manager of New Jersey Manufacturing Facility
 Connie Spooner, Associate Director, Regulatory Affairs
 Elizabeth Smith, VP Regulatory Affairs

Trans-BLA Group: No

 Related STNs: None

Related PMCs: None

Telecon Body:
 A telecon was held at the request of the FDA to cover how the sponsor 
--b(4)---------------------------------- manufacturing at the NJ facility along 
with other CMC questions.  Dendreon began by provided an overview of their 
current clinical manufacturing activity.  The phase II study P07-1 uses only the 
Seattle facility to perform manufacturing.  For P07-2 the NJ facility was being 
used, but that has now been phased out.  P09-1 is the open label study that is 
ongoing and the NJ facility is being used for that, 
--b(4)---------------------------------------------------------  During the 
transition from clinical manufacturing there would be a short period of time 
where a small number of patients would still receive product labeled according 
to clinical manufacturing.  Dendreon proposes to continue manufacturing these 
lots to treat those patients already part of that study until the commercial 
label is available.

The FDA then asked about SOPs and forms currently in use that may no longer 
apply once the commercial product is being made.  For example placebo product 
does not apply to the NJ facility.  Dendreon stated that some SOPs are global 
and would be used across commercial and clinical manufacturing sites whereas 
others are site specific (such as preventative maintenance).  Each manufacturing 
site has a site code and will specify which SOPs apply to that.  For product 
tracking the clinical product and commercial product have separate part numbers 
and the QC lab processes things by part number.

The FDA then asked since some SOPs may be global and some personnel may move 
from facility to facility and they may have a different manufacturing experience 
then at NJ, is there specific training in place to make sure employees know 
which SOPs to follow and which products and testing they will handle?  Dendreon 
responded that all employees go through site specific full training.

The FDA asked about possible confusion of terminology- AIT is defined 
differently in different documents and may refer to different things at 
different manufacturing sites.  Will SOPs be revised to switch over to 
commercial manufacturing?    The site code defines which SOPs apply.

The Agency questioned whether LIMS is used at other manufacturing facilities and 
are there checks in place to be sure software options for products such as 
placebo cannot be inappropriately used at the NJ facility.  Dendreon responded 
that LIMS will be used at other locations as a universal tool and as such will 
be used at all facilities.  LIMS uses the barcode and sample ID number along 
with the part number.  These define the product and should not allow selection 
of product types not manufactured at the NJ facility.  For manual data entry 
there is a second verifier for every entry.  The Agency then asked if the 
process validation study conduction using the b(4) workstations was conducted 
with the latest SOPs and used the LIMS software.  The sponsor indicated that 
LIMS was used.  The sponsor refers to the validation study not as process 
validation but as capacity qualification.  The sponsor clarified that only QC 
has access to LIMS and that QA and the shop floor manager do not have access to 
this tracking software.

The Agency asked about any changeover procedures that might be used for things 
like incubators as they switch over.  Dendreon responded that they will have a 
small time window where a small number of clinical product lots will be made 
along with commercial product and these would not be segregated, but everything 
is processed and tracked identically and the part number and barcodes will 
distinguish them.

The sponsor was asked about how they define full capacity because that was not 
well described in the BLA resubmission other than statingb(4)workstations will 
be used at full capacity.  Dendreon provided an overview of manufacturing shifts 
and their intended manufacturing scale.  Most of the manufacturing occurs 
--b(4)------------------------------------------------------ ------ shifts go 
across a b(4) day manufacturing schedule.  
--b(4)------------------------------------------------------------------------------------------------------------. 
 The other 
--b(4)--------------------------------------------------------------------------------------------------------------. 
 Many of the shipments go out at b(4), though depending on the business hours of 
the infusion sites some might be earlier and some later.  In general shipping 
occurs during the --b(4)----------.  The upper limit for any given workstation 
is b(4) lots per week. Generally they schedule at b(4) of that capacity which 
works out to be b(4) lots per workstation per week.  They will have -b(4)- of 
the staff idle when things are going smoothly.  Each workstation can handle 
-b(4)- lots/month up to -b(4)- maximum.

A discussion followed on product tracking in the QC lab.   The sponsor confirmed 
that some sample tubes in the QC lab would have two barcode labels on them and 
some have one barcode. 

Dendreon provided a overview of their manufacturing expansion plans.  The -b(4)- 
workstation expansion at the NJ facility is expected to be complete and 
validated by the
 ------------------------------------------------------b(4)----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------a
They do plan to roll out manufacturing in a stepwise fashion but do not yet know 
what the real market demand will be.

The Agency confirmed that the inspection is scheduled to take place starting on 
the last week of January.  An 8:30 start time was set.  The overlap between 
--b(4)-------------- manufacturing would occur on -b(4)------.  Much of the 
manufacturing will start after -b(4)--

Dendreon will be closed for the holidays Dec. 24 through Jan. 4.

The call ended at 2:39 PM.
 

   