Document text
From: Gottschalk, Laura
Sent: Friday, July 16, 2021 3:29 PM
To: [email protected]
Cc: 'Aghajani Memar, Neda' <[email protected]>; [email protected]; Naik,
Ramachandra <[email protected]>; Smith, Michael (CBER) <[email protected]>;
[email protected]
Subject: STN 125742/0: IR RE sterility a nd endotoxin methods
Dear Ms. Harkins,
Additional information is needed to complete our review of the sterility and endotoxin methods. Please
submit your responses to the following requests by July 30, 2021.
1. Regarding the sterility method:
a. Please confirm that both PGS -Puurs and PGS -KZO testing facilities will conduct
of sterility tests since test results for were not optimal during the
validation study.
b. Please confirm that both PGS -Puurs and P GS-KZO testing facilities will conduct visual inspection
for growth during the
.
2. Regarding the endoto xin test:
a. Please submit complete verification reports of the endotoxin tests for interfering factors from
both the PGS -Puurs and PGS -KZO facilities. These reports should include positive product control
(PPC) percent recoveries for all drug product sample dilutions tested and the selected testing
dilution that provided the optimal PPC percent recovery. In addition, the reports should identify
the product lot numbers tested instead of referring to them as Trials 1, 2 and 3, as in the
submitted summarized ve rification of bacterial endotoxins report.
Please confirm receipt of this message and let us know if you have any questions.
Best,
Laura
Laura Gottschalk, PhD
Regulatory Project Manager/Primary Reviewer
Center for Biologics Evaluation and Research
Office of Vaccines Research and Review
U.S. Food and Drug Administration
Tel: 301 -796- 0798
laura.gottschalk@fda hhs.gov
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FDA-CBER-2021-5683-1150186