Characterization of gene therapy products and the impact of manufacturing changes on product comparability

Developments in Biologicals

Volumn 122, Issue , 2005, Pages 139-144

  Simek, S L ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT;

ANIMAL; CONFERENCE PAPER; DRUG APPROVAL; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; GENE THERAPY; HUMAN; METHODOLOGY; STANDARD; UNITED STATES;

ANIMALS; BIOLOGICAL PRODUCTS; DRUG APPROVAL; DRUG INDUSTRY; GENE THERAPY; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33644630952     PISSN: 14246074     EISSN: None     Source Type: Book Series    
DOI: None     Document Type: Conference Paper

References (3)

1. Application of Current Statutory Authorities to Cell and Gene Therapy Products. CBER, October 14, Federal Register 1993, Vol 58, No 1977.
2. FDA Guidance Concerning Demonstration of Comparability of Human Biological Product, Including Therapeutics Biotechnology-Derived Products, CBER, FDA, 1996.
3. Draft Guidance for Industry: Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information, CBER, CDER, CVM, FDA. September 3, 2003.