Setting Specifications for a Biotech Therapeutic Product in the Quality by Design Paradigm - Manufacturing using meaningful, science-based specifications will ensure that we attain the optimal balance

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Setting Specifications for a Biotech Therapeutic Product in the Quality by Design Paradigm
Manufacturing using meaningful, science-based specifications will ensure that we attain the optimal balance between manufacturing flexibility and product safety.


BioPharm International
Volume 23, Issue 1

9. Harms J, Wang X, Kim T, Yang J, Rathore AS. Defining design space for biotech products: case study of pichia pastoris fermentation. Biotech Prog. 2008;24:655–62.

10. Rathore AS, Branning R, Cecchini, D. Design space for biotech products. BioPharm Int. 2007;20(4):36–40.

11. Mire-Sluis AR, Barrett YC, Devanarayan V, Koren E, Liu H, Maia M, et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods. 2004;289:1–16.

12. Klakamp SL, Lu H, Tabrizi M, Funelas C, Roskos LK. Application of analytical detection concepts to immunogenicity testing. Anal Chem. 2007;79:8176–84.

13. Barrett YC, Ebling W, Pieniaszek H, Billheimer J, Seiffert D. Validation and implementation of drug-dependent antibody assays in clinical trials for safety monitoring of patients dosed with roxifiban, an orally bioavailable glycoprotein IIb/IIIa antagonist. J Pharmaceut Biomed Anal. 2007;44:938–46.

14. Gupta S, Indelicato SR, Jethwa V, Kawabata T, Kelley M, Mire-Sluis AR, et al. Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. J Immunol Methods. 2007;321:1–18.

15. Schenerman MA, Sunday BR, Kozlowski S, Webber K, Gazzano-Santoro H, Mire-Sluis A. CMC Strategy Forum Report: Analysis and structure characterization of monoclonal antibodies. BioProcess Int. 2004 Feb;42–54.

16. Guideline on development, production, characterization and specifications for monoclonal antibodies and related products. Committee for Medicinal Products for Human Use (CHMP). European Medicines Agency (EMEA). 2008.

17. Wang X, Germansderfer A, Harms J, Rathore AS. Using statistical analysis for setting process validation acceptance criteria for biotech products. Biotech Prog. 2007;23: 55–60.


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