Risk-Based Scientific Approach for Determination of Extractables/Leachables from Biomanufacturing of Antibody–Drug Conjugates (ADCs)

Author:

Ding Weibing

Publisher

Humana Press

Reference13 articles.

1. Ritter A (2012) Antibody–drug conjugates. Pharma Technol 36(1):42–47

2. FDA (2006) Code of federal regulations food and drugs title 21, Part 211.65. US Government Printing Office, Washington, DC. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=211.65&utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=211.65&utm_content=1 . Accessed 26 April 2012

3. EMA (1998) EUDRALEX Volume 4, Chap 3–Premise and Equipment, Section 3.39–Revised Directive 2003/94/EC: Good Manufacturing Practices, Medicinal Products for Human and Veterinary Use. European Commission: Brussels, Belgium. http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/cap3_en.pdf . Accessed 26 April 2012

4. BPSA (2010) BPSA Extractables Guide 2010. Recommendations for testing and evaluation of extractables from single-use process equipment. http://www.bpsalliance.org/ . Accessed 26 April 2012

5. Pall Life Sciences (2009) Validation guide. AllegroTM 2D Biocontainers. USTR 2475a.

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