DEPARTMENT OF HEALTH AND HUMAN SERVICES
TELECONFERENCE MEMORANDUM Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research
Date\Time: April 23, 2007
CBER Representatives: Keith Wonnacott, Malcolm Moos, Lori Tull
Sponsor’s Representative: Elizabeth Smith
STN : 125197/0
Subject: Product Questions
The following requests were conveyed to Dendreon:
- We consider the PA2024 protein to be an active ingredient. Please modify reference to this material to reflect this in future submissions.
- The changes to the b(4) lifetime and process intermediate hold time validation studies proposed in your email of March 26, 2007 were acceptable. Please document them in a future submission.
- With one exception, the revised process control limits proposed in the same communication were acceptable. We request that the upper limit for protein concentration measured by b(4) be set in such a way as to flag a b(4) error or equipment failure. Accordingly, the upper limit should be set to a value consistent with an within the b(4) limit you proposed, whichever is less. We note also that upper and lower limits b(4) for the described in A4-3.2.S.126.96.36.199.1 ( b(4) Part 1 p. 997) should also be specified. Please document the revised limits in a future submission.
- In A4-3.2.S.188.8.131.52.1 (p. 997, paragraph 4), an b(4) is carried out for “b(4)”. Please establish upper and lower limits and include them in a future submission.
- In a future submission, please provide an SOP for the qualitative b(4) for PA2024 described in A4-3.2.P.184.108.40.206.1, including a comparison standard for b(4).