Overview of a quality assurance/quality control compliance program consistent with FDA regulations and policies for somatic cell and gene therapies: a four year experience-Reference-Cited by-同舟云学术

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Overview of a quality assurance/quality control compliance program consistent with FDA regulations and policies for somatic cell and gene therapies: a four year experience

Published:1994 Issue: Volume: Page:365-372
ISSN:1386-2928
Container-title:Cell Culture Engineering IV
language:
Short-container-title:

Author:

du Moulin Gary C.,Pitkin Zorina,Shen Yuan-Jin,Conti Evelyn,Stewart Jean Ko,Charles Carla,Hamilton Dylan

Publisher

Springer Netherlands

Link

http://link.springer.com/content/pdf/10.1007/978-94-011-0257-5_39

Reference15 articles.

1. Aliski WE, Cashon GW, and Osband ME (1991) The regulation of living cell therapies (Biocare). Regulatory Affairs 3: 639–650.

2. Arnow PM, Houchins SG, Richards JM, and Chudy R (1991) Aspirgillus fumigatus contamination of lymphokine — activated killer cells infused into cancer patients. J. Clin. Microbiol. 29: 1038–1041.

3. du Moulin GC, Hamilton DL, Price JE, Kosik ZJ, Liu VYS, Osband ME (1990) Quality assurance and quality control (QA/QC) in biocare. Autolymphocyte therapy as a model. Biopharm. 3: 30–35.

4. du Moulin GC, Price JE, Shen YJ, and Osband ME (1992) Use of the Limulus amebocyte lysate (LAL) assay in living cell therapies. Biopharm. 5: 32–54.

5. du Moulin GC, Liu V, and Osband ME (1992) Implementation of an effective program for quality assurance and quality control in living cell therapy: A two year experience with autolymphocyte therapy. Transplantation Proceedings 24: 2803–2808.

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