Sterility testing of minimally manipulated cord blood products: validation of growth-based automated culture systems

Author:

Akel Salem1,Lorenz Joan1,Regan Donna1

Affiliation:

1. St Louis Cord Blood Bank and Cellular Therapy Laboratory; SSM Cardinal Glennon Children's Medical Center; St Louis Missouri

Publisher

Wiley

Subject

Hematology,Immunology,Immunology and Allergy

Reference29 articles.

1. US Food and Drug Administration General Biologics Standards (21 CFR parts 600, 610 and 680) and Sterility Testing (section 610. 12) 2008

2. United States Pharmacopeia United States Pharmacopeia 28 and National Formulary 23 (USP 28 NF 23) 2005 1 13

3. US Food and Drug Administration Draft guidance for industry. Validation of growth-based rapid microbiological methods for sterility testing of cellular and gene therapy products 2008

4. United States Pharmacopeia General Information Chapter <1223>, Validation of alternative microbiological methods 2009

5. Food and Drug Administration Amendments to Sterility Test Requirements for Biological Products 2011 76 36019 36027

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