PDA Technical Report No. 42: Process validation of protein manufacturing

PDA Journal of Pharmaceutical Science and Technology

Volumn 59, Issue SUPPL. 4, 2005, Pages 1-28

  Bussineau, Chris ^a   Seely, Robert ^b   Lovitt, Genevieve ^c   Fernandez, James ^d   Blank, Greg ^e   Brandreth, E J ^f   Conrad, Doris ^g   Devine, Rebecca A ^o   Ferris, Robert J ^a   De Heyder, Koen ^g   Juffras, Robert W ^h   Levy, Peter ⁱ   List, Wolfgang ^j   Munk, Morten ^k   Neely, Brian C ^l   Notarnicola, Stephen ^m   O'Leary, Rhona ^e   Van Deinse, Harold ⁿ  

^a NOVARTIS PHARMA AG   (Switzerland)

^b AMGEN INC   (United States)

^c Lovitt and Associates

^d Fernandez and Associates LLP   (United States)

^e GENENTECH INC   (United States)

^f Favrille Inc   (United States)

^g GLAXOSMITHKLINE   (United Kingdom)

^h Wyeth BioPharma   (United States)

ⁱ MILLENNIUM PHARMACEUTICALS INC   (United States)

^j Aventis Behring

^k CMC Biopharmaceuticals A/S   (Denmark)

^l Don Hill and Associates Inc   (United States)

^m BIOGEN   (United States)

ⁿ BAXTER HEALTHCARE CORPORATION   (United States)

^o NONE

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; DOCUMENTATION; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; PRACTICE GUIDELINE; PROCESS MONITORING; PROCESS TECHNOLOGY; PROTEIN ANALYSIS; REVIEW; VALIDATION PROCESS;

EID: 27744595813     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

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