Fed-batch or perfusion for the production of biopharmaceuticals by animal cell cultivation?
2009 (English)Other (Other academic)
Fed-batch or perfusion modes are today’s options for the cultivation process development of new candidates drugs. In the cases of unstable proteins, perfusion is the obligatory choice. Otherwise, this choice is dictated by the need of simplicity, the existing technical know-how in the company and the available equipment (e.g. bioreactor size, perfusion device, etc.). The higher risk of contamination and higher technical challenge of perfusion processes lead often to the selection of fed-batch for commercial processes. This is reinforced today in the case of antibody production in established biotech companies by the use of generic fed-batch processes with high yield production and low accumulation of toxic by-products (e.g. lactate, ammonia). However perfusion can be a valuable option due to the usage of smaller bioreactors, today’s availability of scalable low shear force perfusion system (e.g. ATF) and potentially the lower requirement of process development for perfusion. Perfusion can therefore be an attractive choice for instance for the production of glycoproteins, which are not antibody, and/or for small companies, which do not have generic process.
Place, publisher, year, edition, pages
perfusion, fed-batch, animal cell culture
Research subject SRA - Molecular Bioscience
IdentifiersURN: urn:nbn:se:kth:diva-87478OAI: oai:DiVA.org:kth-87478DiVA: diva2:501692
Invited speaker at the workshop Securing Quality in Bioanalysis and Production, CELS, CEFFORT, Nov 25, 2009, Stockholm, Sweden. QC 201202142012-02-142012-02-142012-02-14Bibliographically approved