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Design and operation of a current good manufacturing practices cell-engineering laboratory

  • Published:2000-02 Issue:2 Volume:2 Page:111-122
  • ISSN:1465-3249
  • Container-title:Cytotherapy
  • language:en
  • Short-container-title:Cytotherapy

Author:

Burger Scott R.

Publisher

Elsevier BV

Subject

Cancer Research,Transplantation,Cell Biology,Genetics(clinical),Oncology,Immunology,Immunology and Allergy

Reference26 articles.

1. Proposed approach to regulation of cellular and tissue-basedproducts. Docket Number 97N-0068, February 28, 1997.

2. FDA's proposed regulatory approach to regulation of hematopoietic stem/progenitor cell products;Harvath;Cytotherapy,1999

3. Current good manufacturing practice for finished pharma-ceuticals. 21CFR211.

4. Current good manufacturing practices;Zuck;Transfusion,1995

5. Big biotech: designing the plant of the future;Williams;Bio Pharm,1997

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