Best Practices for Formulation and Manufacturing of Biotech Drug Products - How to maintain product stability and prevent particulates. - BioPharm International

ADVERTISEMENT

Best Practices for Formulation and Manufacturing of Biotech Drug Products
How to maintain product stability and prevent particulates.


BioPharm International
Volume 22, Issue 6

16. Matveev YI, Ablett S. Calculation of the Cg' and Tg' interaction point in the state diagram of frozen solutions. Food Hydrocolloids. 2002;16:419–22.

17. Strambini GB, Gabellieri E. Proteins in frozen solutions: evidence of ice-induced partial unfolding. Biophys J. 1996;70:971–76.

18. Shalaev E, Franks F. Solid-liquid state diagrams in pharmaceutical lyophilisation: crystallisation of solutes, progress in amrophous food and pharmaceutical systems. Levine H, editor. UK: The Royal Society of Chemistry; 2002. p. 200–15

19. Chang BS, Randall CS. Use of subambient thermal analysis to optimize protein lyophilization. Cryobiol. 1992;29:632–56.

20. Carpenter JF, Pikal MJ, Chang BS, Randolph TW. Rational design of stable lyophilized protein formulations: some practical advice. Pharm Res. 1997;14:969–75.

21. Webb SD, Webb JN, Hughes TG, Sesin DF, Kincaid AC. Freezing biopharmaceuticals using common techniques—and the magnitude of bulk-scale freeze-concentration. BioPharm Int. 2002;15:22–34.

22. Lashmar UT, Vanderburgh M, Little SJ. Bulk freeze-thawing of macromolecules. Effect of cryoconcentration on their formulation and stability. BioProcess Int. 2007;5:44–54.

23. Peters EN. Plastics: thermoplastics, thermosets and elastomers. In: M Kutz, editor. Handbook of materials selection. New York: John Wiley and Sons; 2002. p. 336–37.

24. Eisai Machinery U.S.A. Inc. [homepage on the Internet]. Available from: http://www.eisaiusa.com/

25. Brevetti CEA [homepage on the Internet]. Available from: http://www.brevetti-cea.com/

26. Seldenader [homepage on the Internet]. Available from: http://www.seidenader.de/

27. Knapp JZ, Abramson LR. Automated particulate inspection systems: strategies and implications. J Pharm Sci Technol.1990;44:74–107.

28. Knapp JZ. Overview of the forthcoming PDA task force report on the inspection for visible particles in parenteral products: practical answers to present problems. J Pharm Sci Technol. 2007;75:131–47.

29. Cromwell MEM, Hilario E, Jacobson F. Protein aggregation and bioprocessing. AAPS J. 2006;8(3):E572–79.

30. Sharma DK, et al. Flow microscopy for particulate analysis in parenteral and pharmaceutical fluids. Euro J Parent Pharma Sci. 2007;12(4):97–101.

31. Jones LS, Kaufmann A, Middaugh CR. Silicone oil induced aggregation of proteins. J Pharm Sci. 2005;94(4):918–27.


blog comments powered by Disqus

ADVERTISEMENT

Moscow Hosts IFPMA Biosimilars Conference
May 17, 2013
AbbVie and Alvine Will Collaborate on Celiac Disease Therapy
May 15, 2013
FDA Issues Pharmacoepidemiologic Safety Study Guidance
May 14, 2013
USP Launches Initiative to Fight Counterfeit Drugs in Sub-Saharan Africa
May 13, 2013
Amgen Forms New Joint Venture to Commercialize Vectibix in China
May 13, 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