With abundant experience in Current Good Manufacturing Practice (cGMP) bioprocess, Creative Biogene has the capability to implement fermentation projects using different yeast strains.
Two common species of the yeasts have been commercially utilized to manufacture well-folded recombinant proteins and they are Pichia Pastoris and Saccharomyces cerevisiae respectively.
• Comprehensive strain development and cGMP production of pre-master cell bank
• Bioprocess development under cGMP regulations
• Downstream process development including harvest, purification and quality control methods
• cGMP pre-clinical and commercial manufacturing of pharmaceutical proteins
• State-of-the-art cGMP fermentation facility and experienced scientists
• Pharmacopoeia (EP/USP) methods and ICH guidelines
Compared with other cell factories, Pichia pastoris is well established to produce human-like proteins that can be glycosylated intracellularly with appropriate folding. It has a rapid growth rate and can produce high yields of recombinant proteins. Pichia pastoris is suitable for production of recombinant proteins and is a viable alternative to mammalian cells.
Overall, the advantages of Pichia pastoris include time saving, cost-effective properties, and the secretion system. The secretion of recombinant proteins into the extracellular environment enables the high quality of the products and simplified downstream process with a low cost.
Historically, Saccharomyces cerevisiae was utilized as a host for various pharmaceutical protein production. For example, the hormones insulin and glucagon have been commercially manufactured by using Saccharomyces cerevisiae.
As one of the leading microbial fermentation service providers, Creative Biogene is evaluating new development projects to improve our capacity for Saccharomyces cerevisiae production platform and we are pleased to talk about your fermentation projects using the strain.
• QC release testing
• QP certification and full GMP documentation
• Storage and stability testing
• State-of-the-art heat ventilation and air conditioning
Pichia Pastoris and Saccharomyces cerevisiae are widely used for the production of pharmaceutical proteins, monoclonal antibody (mAb), peptide fragments. All above of the bioprocesses can be operated using Creative Biogene's cGMP facilities under strict guidelines and regulations.
With years of experience in cGMP fermentation, we believe that our professional and extensive cGMP fermentation services using yeasts would meet your needs and help with your promising projects a lot.
If you have any requirements about yeast cGMP fermentation,please contact us with no hesitation.
1. Huang, M., Bao, J., & Nielsen, J. (2014). ‘Biopharmaceutical protein production by Saccharomyces cerevisiae: current state and future prospects.' Pharmaceutical Bioprocessing, 2(2), 167-182.
2. Tran, A. M., Nguyen, T. T., Nguyen, C. T., Huynh-Thi, X. M., Nguyen, C. T., Trinh, M. T., Tran, L. T., Cartwright, S. P., Bill, R. M., & Tran-Van, H. (2017). ‘Pichia pastoris versus Saccharomyces cerevisiae: a case study on the recombinant production of human granulocyte-macrophage colony-stimulating factor.' BMC research notes, 10(1), 148.