Optimization, scale-up, and validation issues in filtration of biopharmaceuticals, part I

BioPharm International

Volumn 17, Issue 8, 2004, Pages 50-58

  Rathore, Anurag S ^a   Wang, Alice ^b   Menon, Manoj ^b   Riske, Frank ^b   Campbell, Jennifer ^b   Godrich, Elizabeth ^b   Martin, Jerold ^b  

^a AMGEN INC   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

CROSSFLOW FILTRATION; DEVICE; DIAFILTRATION; DRUG MANUFACTURE; FILTRATION; FLOW RATE; HEPATITIS B VIRUS; HEPATITIS C VIRUS; HERPES SIMPLEX VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS 1; POLIOMYELITIS VIRUS; PROCESS DEVELOPMENT; REVIEW; SCALE UP; SIMIAN VIRUS 40; SINDBIS VIRUS; ULTRAFILTRATION; VALIDATION PROCESS;

EID: 4043097858     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (7)

1. A Wang, L Russell, T Tressel, A S Rathore, ACS Poster # 263, 227th ACS National Meeting, Anaheim, CA, 2004.
2. Millipore Application Note, Filter Sizing Methods- for Normal Flow Filtration Applications, Document # AN1512EN00.
3. D Uavorsky, S McGee, Selection and Sizing of Clarification Depth Filters, Genetic Engineering News, Vol. 22, No. 9, May 1, 2002.
4. Sterilizing Filtration of Liquids, Technical Report No. 26, PDA, 1998.
5. Note of Guidance on Virus Validation Studies: The design, contribution and interpretation of studies validating the inactivation and removal of viruses, CPMP EMEA, 1996.
6. Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, ICH Harmonized Tripartite Guideline, 1997.
7. Guideline on Sterile Drug Products Produced by Aseptic Processing, FDA, 1987.