GMP Biomanufacturing
Production in Pichia pastoris
Pichia pastoris (also known as Komagataella or Hansenula) is a widely used expression system for the production of complex recombinant proteins for clinical and commercial human use.
We offer significant experience in the design, optimization, scale-up and GMP manufacturing of products based on the secretion of correctly folded recombinant proteins.
The advantages of using Pichia pastoris
P. pastoris offers high growth rates using simple and inexpensive fermentation media.
The short manufacturing times ensure a cost-effective production approach.P. pastoris offers a viable alternative
to mammalian expression systems when mammalian glycosylation is not required for product activity.
Folded proteins
P. pastoris is advantageous for the production of complex proteins containing disulphide bridges.
P. pastoris secretes the correctly folded protein extracellularly into the fermentation media.
Low contaminants
P. pastoris does not contain a lipopolysaccharide outer membrane responsible for endotoxin contamination and can secrete protein extracellularly.
There is very little contamination in the fermentation media. Host cell proteins and residual DNA and RNA remain inside the cell.
These characteristics allow to provide highly pure product.
Highly scalable
Fermentation conditions are highly scalable such as for E.coli.
P.pastoris is routinely used for the production of commercial eukaryotic biopharmaceuticals such as insulin.
Regulatory
All GMP material is produced in accordance to FDA 21 CFR Part 210 & 211, EU 2003/94/EC, Eudralex Vol 4, and relevant ICH; the regulatory requirements for sterile injectable products intended for human clinical trials and commercialization.