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Subject: Fwd: [DCHAS-L] [New post] Journal of Chemical Health & SafetyÕs March-April issue
Date: Tuesday, April 5, 2016 7:38:45 AM
Author: "Secretary, ACS Division of Chemical Health and Safety" <secretary**At_Symbol_Here**DCHAS.ORG> 		Next by Date:
Subject: [DCHAS-L] Chemical Safety headlines from Google (14 articles)
Date: Wed, 6 Apr 2016 06:10:12 -0400
Author: "Secretary, ACS Division of Chemical Health and Safety"

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

 

Find West on Twitter and LinkedIn.

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Find West on Twitter and LinkedIn.

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