Regulatory considerations for raw materials used in biological products

PDA Journal of Pharmaceutical Science and Technology

Volumn 64, Issue 5, 2010, Pages 451-457

  Khan, A S ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Adventitious agents; Cell substrates; Product safety; Raw materials

Indexed keywords

BIOLOGICAL PRODUCT; BOVINE SERUM ALBUMIN; TRYPSIN;

BLOOD; BODY FLUID; CELL DIFFERENTIATION; CELL GROWTH; CELL SELECTION; CHO CELL; GOOD MANUFACTURING PRACTICE; HOST CELL; HUMAN; HYBRIDOMA CELL CULTURE; NONHUMAN; REVIEW; RISK REDUCTION; VIRAL CONTAMINATION; VIRUS;

BIOLOGICAL PRODUCTS; HUMANS; VIRUSES;

EID: 78149352540     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (45)

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