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

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:1994-02 Issue:1-3 Volume:15 Page:365-372
ISSN:0920-9069
Container-title:Cytotechnology
language:en
Short-container-title:Cytotechnology

Author:

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

Publisher

Springer Science and Business Media LLC

Subject

Cell Biology,Clinical Biochemistry,Biomedical Engineering,Bioengineering,Biotechnology

Link

http://link.springer.com/content/pdf/10.1007/BF00762411.pdf

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 contamintion 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 theLimulus 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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