Developing Cell Therapy biomanufacturing processes

Chemical Engineering Progress

Volumn 106, Issue 11, 2010, Pages 50-55

  Rowley, Jon A ^a  

^a Lonza Walkersville Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALLOGENEIC CELLS; BIOMANUFACTURING; BIOREACTOR CULTURES; CELL BANKS; CELL THERAPY; CLINICAL DEVELOPMENT; CULTURED CELL; DOWNSTREAM PROCESS; LIQUID VOLUME; MANUFACTURING PROCESS; PHARMACEUTICAL PRODUCTS; PRODUCT SAFETY; QUALITY ATTRIBUTES; TECHNOLOGY PLATFORMS; UPSTREAM PROCESS;

CELLS; DRUG PRODUCTS; INDUSTRIAL ENGINEERING; MANUFACTURE; PRODUCTION ENGINEERING; SAFETY TESTING;

CELL CULTURE;

EID: 79956020160     PISSN: 03607275     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (5)

1. U.S. Food and Drug Administration, "Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy investigational New Drug Applications (INDs)," U.S. FDA, Center for Biologic Evaluation and Research. Rockville, MD, www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianeeRegulatorylnforination/Guidances/-
2. Xenotransplantation/ucm074131.htm (Apr. 2008).
3. U.S. Food and Drug Administration, "Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products." U.S. FDA, Center for Biologics Evaluation and Research. Rockville, MD, www.fda.gov/ BioIogicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/ Cellularand-GeneTherapy/ucm072571.htm (Oct. 2008).
4. U.S. Food and Drug Administration, "ICH Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process," U.S. FDA, Rockville. MD, www.fda.gov/OHRMS/DOCKETS/98fr/2004d- 0U8-gd10001.pdf (Nov. 13, 2003).
5. Kirouac, D. C., and P. W. Zandstra, "The Systematic Production of Cells for Cell Therapy,'" Cell Stem Cell, 3 (4), pp. 369-381 (Oct. 9, 2008).