Disposable Components Enable a New Approach to Biopharmaceutical Manufacturing

BioPharm International

Volumn 17, Issue 3, 2004, Pages 38-49

  Hodge, Geoffrey ^a  

^a Quality and Regulatory Affairs   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT; BIOPHARMACEUTICAL PRODUCT; MONOCLONAL ANTIBODY; RECOMBINANT PROTEIN; STAINLESS STEEL; UNCLASSIFIED DRUG;

BIOPROCESS; BIOREACTOR; COST; DISPOSABLE EQUIPMENT; DRUG MANUFACTURE; ECONOMIC ASPECT; ENGINEERING; EQUIPMENT; INSTRUMENT STERILIZATION; LABORATORY; PILOT STUDY; QUALITY CONTROL; REVIEW; VALIDATION PROCESS; WASTE DISPOSAL;

EID: 1542328141     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (5)

1. Bennan J, Bing F, Boone H, Fernandez J, Seely B, van Deinse H, Miller D. Evaluation of extractables from product-contact surfaces. BioPharm International 2002;15(12):22-34.
2. Jenke D. Extractable/leachable substances from plastic materials used as pharmaceutical product containers/devices. PDA Journal 2002;56(6):332-370.
3. Sinclair A, Monge M. Quantitative economic evaluation of single use disposables in bioprocessing. Pharmaceutical Engineering, 2002;22(3):20-34.
4. Hodge G. Economics of disposable process components for the manufacture of monoclonal antibodies. IBC: Antibody Production and Downstream Processing Conference; 2002 September 24; London, England.
5. Hodge G. Use of disposable bioprocess equipment for antibody production. Waterside Conference; 2002 May 20; Savannah, Georgia.