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

ADVERTISEMENT

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.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

First Biosimilar Application Kicks Off Legal Battle
October 31, 2014
FDA Approves Pfizer's Trumenba for the Prevention of Meningitis B
October 30, 2014
EMA: Extrapolation Across Indications for Biosimilars a Possibility
October 30, 2014
Bristol-Myers Squibb Announces Agreement to Acquire HER2-Targeted Cancer Treatment
October 29, 2014
Amgen, Sanofi, and Ono Pharmaceuticals Partner with Universities on Transmembrane Protein Research
October 28, 2014
Author Guidelines
Source: BioPharm International,
Click here