DCHAS-L Discussion List Archive
From: "Biersack, Mary" <Mary.Biersack**At_Symbol_Here**WESTPHARMA.COM>
Subject: [DCHAS-L] monoclonal antibody drug products
Date: Tue, 5 Apr 2016 20:25:08 +0000
Reply-To: DCHAS-L <DCHAS-L**At_Symbol_Here**MED.CORNELL.EDU>
Message-ID: AA020255FC11BE4BA08B0AC8248D7B29767EB945**At_Symbol_Here**usvfmbx02
Hello,
Our chemistry lab tests the containers that hold drug products. Most of these drug products are humanized recombinant
monoclonal antibodies like the drug product Avastin. If an FDA registered drug product (ready for human use) is derived from human blood (like a monoclonal antibody) is it considered biohazardous and the blood borne pathogen standard applies when our scientists
test the container that houses this drug product. According to NIOSH drugs are considered hazardous if they have any of the following characteristics:
Carcinogenicity, Teratogenicity or other developmental toxicity, Reproductive toxicity, Organ toxicity at low doses or Genotoxicity but it doesn’t mention anything about Biohazardous.
Thanks,
Mary
Mary Biersack
Lab Safety and Chemical Hygiene Specialist
West Pharmaceutical Services, Inc.
P: +1 610-594-3278
530 Herman O. West Drive
| Exton, PA 19341 | United States
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Find West on
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