Manufacturing models permitting roll out/scale out of clinically led autologous cell therapies: Regulatory and scientific challenges for comparability

Cytotherapy

Volumn 16, Issue 8, 2014, Pages 1033-1047

  Hourd, Paul ^a   Ginty, Patrick ^a   Chandra, Amit ^a   Williams, David J ^a  

^a LOUGHBOROUGH UNIVERSITY   (United Kingdom)

Author keywords

Autologous cell therapy; Comparability; GMP; Manufacturing; Point of care; Scale out

Indexed keywords

AUTOLOGOUS CELL THERAPY; CELL COMPOSITION; CELL EXPANSION; CELL FUNCTION; CELL LINE; CELL THERAPY; CELL TRANSFORMATION; COMPARATIVE STUDY; CONSENSUS; EPIGENETICS; GOOD MANUFACTURING PRACTICE; HUMAN; LICENSING; MEDICAL TECHNOLOGY; PRIORITY JOURNAL; PRODUCT SAFETY; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SCIENTIFIC LITERATURE; UNITED KINGDOM; UNITED STATES; BIOLOGICAL THERAPY; ECONOMICS; EUROPE; STANDARDS; TRENDS;

CELL- AND TISSUE-BASED THERAPY; EUROPE; HUMANS; UNITED STATES;

EID: 84903820011     PISSN: 14653249     EISSN: 14772566     Source Type: Journal    
DOI: 10.1016/j.jcyt.2014.03.005     Document Type: Review

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