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

Lonza Introduces Risk Assessment Platform for Biopharmaceuticals
June 19, 2013
GSK Receives Offer for its Thrombosis Brands and Related Manufacturing Site
June 19, 2013
Elan Proceeds with Formal Sale Process of Company; Royalty Pharma Drops Bid
June 19, 2013
RAME-HART Technology Helps Boost Vaccine Production in Emerging Markets
June 19, 2013
Pfizer Wins Multibillion-Dollar Settlement from Teva and Sun for Infringement of Protonix Patent
June 19, 2013
Upcoming Conferences
UPCOMING CONFERENCES

Access Programs for Investigational and Pre-Launch Drugs
Philadelphia, PA | July 17-18, 2013
Request Brochure

Strategic Pipeline Planning & Portfolio Valuation
Philadelphia, PA | August 13-14, 2013
Request Brochure

MES 2013 - Forum on Manufacturing Execution Systems
Philadelphia, PA | August 14-15, 2013
Request Brochure

Mobile Innovation for the Life Sciences Industry
Philadelphia, PA | August 20-21, 2013
Request Brochure

See All Conferences >>

ADVERTISEMENT

Author Guidelines
FindPharma
Source: BioPharm International,
Click here