Is cell culture to replace microbial fermentation in the biologics arena ?
This question is certainly a common one for those looking at the industry overall and trying to decide where they want to invest their efforts. Traditionally microbial fermentation operations had been focused on the food and beverage industry starting centuries ago, and over the past couple of decades the method of production evolved into a biologics production vehicle, with the advent of new technologies to manipulate genes, we have started to find new use for microbial fermentation.
Why microbial fermentation for biologics production continues to grow
The use of microbial fermentation in the production of pharmaceuticals includes various therapeutic peptides, insulin, vaccines and even cancer therapeutics which is one of the areas of much attention in late! This method presents a lot of advantages in that production can happen over a short period of time, microbes are robust and as such can be cultured in a high density producing high yields of the target. At the same time microbial fermentation also has its limits, and generally speaking, this has to do with the complexity of the target molecule. As you start into more complex molecules like monoclonal antibodies, antibody fragments, larger antigens, antibody-drug conjugates, the requirements to produce the molecule in its useful conformation (ie. Folded and structured to be useful) cannot be addressed by microbial fermentation and then must be tackled with cell culture.
Though cell culture is a lot more challenging to carry out, requires more time and takes significantly more resources as the yields are lower, the complexity of the cells themselves offer up the capability of the necessary post translation modifications to produce the target.
Biodextris continues to offer its expertise in microbial fermentation as this market evolves
At Biodextris we originally started exclusively in the arena of microbial fermentation as a vehicle but over the past few years we recognized the ever growing arena of complex biologics and have adapted by outfitting our facilities with GMP cell culture production infrastructure to address our clients in both arenas, microbial fermentation and cell culture alike. Considering recent data would indicate that Europe and North America will capture more than 80 percent of the estimated $9.3 billion dollar microbial fermentation market by 2030, it’s no wonder there is no immediate plans to discontinue these services.
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Published online 2009 Dec 2. doi: 10.4161/bbug.1.3.10903
PMCID: PMC3026423 PMID: 21326924 Microbial-based therapy of cancer
Current progress and future prospects Nuno Bernardes,1 Raquel Seruca,2 Ananda M Chakrabarty,3 and Arsenio M Fialho1