Current perspectives on the use of ancillary materials for the manufacture of cellular therapies

Cytotherapy

Volumn 18, Issue 1, 2016, Pages 1-12

  Solomon, Jennifer ^a   Csontos, Lynn ^a   Clarke, Dominic ^b   Bonyhadi, Mark ^c   Zylberberg, Claudia ^d   McNiece, Ian ^e   Kurtzberg, Joanne ^f   Bell, Rosemarie ^g   Deans, Robert ^h  

^a StemCell Technologies Inc   (Canada)

^b Charter Medical Ltd   (United States)

^c Juno Therapeutics   (United States)

^d Akron Biotech   (United States)

^e UNIVERSITY OF TEXAS   (United States)

^f DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g QIMR BERGHOFER MEDICAL RESEARCH INSTITUTE   (Australia)

^h Rubius Therapeutics   (United States)

Author keywords

Ancillary materials; Cellular therapy; CGMP; Raw materials; Regulation; Stem cell research; Translational medical research

Indexed keywords

ANCILLARY MATERIAL; REAGENT; UNCLASSIFIED DRUG;

ARTICLE; AUSTRALIA; BIOCHEMICAL COMPOSITION; CELL THERAPY; CLINICAL EFFECTIVENESS; CLINICAL TRIAL (TOPIC); COMMERCIAL PHENOMENA; CONCEPTUAL FRAMEWORK; DEVICE SAFETY; EUROPE; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; GOVERNMENT REGULATION; HUMAN; INTERNATIONAL COOPERATION; JAPAN; MEDICAL RESEARCH; NOMENCLATURE; NONHUMAN; PATIENT SAFETY; PRIORITY JOURNAL; PROCEDURES CONCERNING CELLS; QUALITY CONTROL; RISK MANAGEMENT; STANDARDIZATION; UNITED STATES; BIOLOGICAL THERAPY; PROCEDURES; SOCIAL CONTROL;

CELL- AND TISSUE-BASED THERAPY; HUMANS; INTERNATIONALITY; SOCIAL CONTROL, FORMAL; TERMINOLOGY AS TOPIC;

EID: 84955315968     PISSN: 14653249     EISSN: 14772566     Source Type: Journal    
DOI: 10.1016/j.jcyt.2015.09.010     Document Type: Article

References (19)

1. Alliance for Regenerative Medicine 2014 Regenerative Medicine Annual Industry Report 2014.
2. Schachter B. Therapies of the state. Nature 2014, 32(8):736-741.
3. USP 37 USP <1043> Ancillary Materials for Cell, Gene and Tissue Engineered Products 2014.
4. International Conference on Harmonization (ICH) Harmonised Tripartite Guideline Pharmaceutical Quality System Q10 2008.
5. European Medicines Agency Draft guideline on the risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to Advanced Therapy Medicinal Products 2012.
6. Health Canada Draft guidance document-Guidance for Sponsors: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans 2014.
7. British Standards Institution PAS 84:2012. Cell therapy and regenerative medicine-glossary 2012, British Standards Institution Standards Limited. 2nd ed.
8. USP 37 USP <1046> Cell and Gene Therapy Products: USP 2014.
9. FDA.Guidance for Industry CGMP for Phase 1 Investigational Drugs 2008.
10. ISO Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process 2009.
11. FDA 21 CFR 210 Current Good Manufacturing Practice (Drugs) 2009.
12. FDA 21 CFR 211 Current Good Manufacturing Practice (Drugs) 2009.
13. FDA 21 CFR 610.15: General Biologicals Products Standards; Constituents materials 2009.
14. FDA 21 CFR 820 Quality System Regulation (Devices) 2009.
15. USP 37 USP <90> Fetal Bovine Serum Quality Attributes and Functionality Tests: USP 2014.
16. USP 37 USP <92> Cytokines and Growth Factors Quality Attributes: USP 2014.
17. Therapeutic Goods Administration Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products 2013.
18. Baum E., Littman N., Ruffin M., Ward S., Aschheim K. Key Tools and Technology Hurdles in Advancing Stem-Cell Therapies, A White Paper Sponsored by: California Institute for Regenerative Medicine, Alliance for Regenerative Medicine and Cell Therapy Catapult 2013, June 25, Roundtable.
19. International Conference on Harmonization (ICH) Harmonized Tripartite Guideline Quality Risk Management Q9 2005.