Continuing challenges for leachables characterization of materials used in biopharmaceutical manufacturing

American Pharmaceutical Review

Volumn 11, Issue 4, 2008, Pages

  Strong, Richard ^a   Hurst, Chris ^a  

^a BIOGEN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOMATERIAL; POLYPROPYLENE;

CELL LINE; CHROMATOGRAPHY; DRUG INDUSTRY; FERMENTATION; GOOD MANUFACTURING PRACTICE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LEACHING; MASS SPECTROMETRY; PURIFICATION; QUALITY CONTROL; REVIEW; ULTRAVIOLET RADIATION;

EID: 55849117347     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (12)

1. U.S. Food andDrug Administration, Center for Biologics Evaluation and Research, "Guidance for Industry: Container Closure Systems for Packaging HumanDrugs and Biologics, Chemistry,Manufacturing and Controls Documentation", 1999.
2. U.S. Food andDrug Administration, Code of Federal Regulations, CFR Title 21, §211.65.
3. D. R. Jenke, "Extractable/Leachable Substances fromPlasticMaterials Used as Pharmaceutical Containers/Devices", PDA Journal of Pharmaceutical Science and Technology, 2002, 55(6), pp. 332-371.
4. J. Bennan et. al. "Evaluation of Extractables fromProduct-Contact Surfaces", BioPharmInternational,Dec. 2002, pp. 22-34.
5. D. L. Norwood et. al. "Application ofModern Analytical Technologies to the Identification of Extractables and Leachables", American Pharmaceutical Review, 2005, 8(1), pp. 78-86.
6. D. R. Jenke, "Linking Extractables and Leachables in Container/Closure Applications", PDA Journal of Pharmaceutical Science and Technology, 2005, 59(4), pp. 265-281.
7. K. Nicholas, "Extractables and LeachablesDetermination: A Systematic Approach to Select and Qualify a Container Closure Systemfor a Pharmaceutical Product", American Pharmaceutical Review, 2006, 9(3), pp. 21-27.
8. R. Colton et. al. "Recommendations for Extractables and Leachables Testing: Part I", BioProcess International, 2007, 5(11), pp. 36-44.
9. R. Colton et. al. "Recommendations for Extractables and Leachables Testing: Part II", BioProcess International, 2008, 6(1), pp. 44-52.
10. I. C.Munro, et. al."Correlation of structural class with no-observed-effect levels: a proposal for establishing a threshold of concern" Food Chem. Toxicol., 1996, 34(9), pp. 829-867.
11. I. C.Munro, et. al."A procedure for the safety evaluation of flavouring substances. Joint FAO/WHOExpert Committee on Food Additives", Food Chem. Toxicol., 1999, 37(2-3), pp. 207-232.
12. R. Kroes, et. al. "Threshold of toxicological concern for the chemical substances present in the diet: a practical too for assessing the need for toxicity testing" Food Chem. Toxicol., 2000, 38(2-3), pp 255-312.