Cytotechnology

, Volume 42, Issue 1, pp 21–33

Equipment design considerations for large scale cell culture

  • David M. Marks
Article

DOI: 10.1023/A:1026103405618

Cite this article as:
Marks, D.M. Cytotechnology (2003) 42: 21. doi:10.1023/A:1026103405618

Abstract

Equipment design is frequently recognized as a key component in the success of GMP biologics manufacturing, but is not always implemented with full appreciation of the processing implications. In the case of mammalian cell culture, there are some recognized issues and risks that develop when transitioning to a large scale of operation. The developing demand for cell culture production capacity in the biopharmaceutical industry has led to a progressive increase in the scale of operation in the last decade. This review will provide a high level summary of the documented process difficulties unique to serum-free large scale (LS) cell culture, analyze the engineering constraints typical of these processes, and suggest some practical equipment design considerations to enhance the productivity, reliability and operability of such systems under GMP manufacturing conditions. A systems approach will be used to establish a good LS bioreactor design practice, providing a discussion on gas distribution, agitation, vessel design, SIP/CIP and control issues.

BioreactorCell cultureLarge scaleMass transferMixingScale upStirred tank

Copyright information

© Kluwer Academic Publishers 2003

Authors and Affiliations

  • David M. Marks
    • 1
  1. 1.DME Alliance IncorporatedAllentownUSA (e-mail