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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)---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 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.