Qualification of academic facilities for small-scale automated manufacture of autologous cell-based products

Regenerative Medicine

Volumn 9, Issue 6, 2014, Pages 799-815

  Hourd, Paul ^a   Chandra, Amit ^a   Alvey, David ^b   Ginty, Patrick ^a   McCall, Mark ^a   Ratcliffe, Elizabeth ^a   Rayment, Erin ^a   Williams, David J ^a  

^a LOUGHBOROUGH UNIVERSITY   (United Kingdom)

^b Kitenics Ltd   (United Kingdom)

Author keywords

ATMP; autologous; automation; cell therapy; GMP; manufacturing; qualification; regulation; validation

Indexed keywords

ARCHITECTURE; ARTICLE; AUTOMATION; CELL THERAPY MANUFACTURING FACILITY; GOOD MANUFACTURING PRACTICE; HEALTH CARE FACILITY; ORGANIZATIONAL EFFICIENCY; ORGANIZATIONAL STRUCTURE; QUALITY CONTROL; STRATEGIC PLANNING; VALIDATION PROCESS; AUTOTRANSPLANTATION; BIOLOGICAL THERAPY; HUMAN; LEGISLATION AND JURISPRUDENCE; REGENERATIVE MEDICINE; STANDARDS; UNIVERSITY HOSPITAL;

ACADEMIC MEDICAL CENTERS; AUTOMATION; CELL- AND TISSUE-BASED THERAPY; HUMANS; REGENERATIVE MEDICINE; TRANSPLANTATION, AUTOLOGOUS;

EID: 84913610220     PISSN: 17460751     EISSN: 1746076X     Source Type: Journal    
DOI: 10.2217/rme.14.47     Document Type: Article

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