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Media formulation options and manufacturing process controls to safeguard against introduction of animal origin contaminants in animal cell culture.

Authors :
Jayme, David
Smith, Shawn
Source :
Cytotechnology; Jul2000, Vol. 33 Issue 1-3, p27-36, 10p
Publication Year :
2000

Abstract

Technical limitations and evolution of therapeuticapplications for cell culture-derived products haveaccelerated elimination of animal-derived constituentsto minimize inadvertent introduction of adventitiousviral or prion agents. Practical considerationsdemand adequate emphasis both on design of theserum-free/protein-free culture environment and onnutrient media manufacturing process controls. Protein components may be acceptable, given adequateattention to synthetic process, sourcing (e.g.,geographic location and endemicity, species andtissue/organ) and validated treatment method. Variousoptions exist for re-engineering of traditionalserum-free formulations (containing insulin,transferrin and other protein factors) withnon-protein substitutes. Caution must also beexercised with sourcing of non-protein additives,particularly amino acids and lipids, to avoidintroducing adventitious contaminants. Simpleguidelines facilitate adaptation, cryopreservation andrecovery of many cell types within a protein-freeculture environment. Scrupulous maintenance offacility and equipment and monitoring of processwater, air handling systems and technical personnelare required to ensure that approved raw materials arecorrectly formulated and dispensed. Validatedsanitization processes provide additional assuranceagainst cross-contamination from previous batches ina multi-use facility. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
09209069
Volume :
33
Issue :
1-3
Database :
Complementary Index
Journal :
Cytotechnology
Publication Type :
Academic Journal
Accession number :
50024121
Full Text :
https://doi.org/10.1023/A:1008133717035