BioPharmaceuticals Production
GMP Recombinant Proteins
We develop processes and manufacture GMP recombinant proteins for clinical trial and commercial uses.
All GMP material is produced in accordance to US, EU and Japanese regulatory requirements for sterile injectable products.
All Expression Strategies
We are focused on microbial production systems and have experience in the manufacturing of proteins using all expression strategies: refolding of inclusion bodies, selective periplasmic expression, secreted into the media and soluble cytoplasmic.
Processes are designed using scalable high yielding fed-batch fermentation and purification methods to generate process that can go from clinic to commercial.
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batch released
Significant Experience
We have developed over 150 different GMP processes and release over 650 batches of GMP material. To date we have produced a large variety of molecules such as enzymes, cytokines, growth factors, antibody fragments, fusion proteins, recombinant vaccines, DNA binding proteins, core antigens, and inhibitors.
We produce in all the important microbial strains
- E. coli
- P. pastoris
- H. polymorpha
- S. cerevisiae
- Biosafety level 2 micro-organisms that are non-sporulating
Highly flexible approach
We understand that all customer projects are unique and have adapted development strategies and project management approaches to match your needs.
Development, transfer and process optimization approaches from your research or GMP cell bank are all possible.
Process development
We offer process development strategies in line with our customer’s business model.
We understand that small biotech companies often need to generate clinical data quickly
while other companies such as big pharma like to establish reproducibility and scalability early in the development process.
Accordingly, we develop process following the FastTrack or OptiTrack method, both offering GMP material suitable for clinical trials.
The FastTrack process development consists of using our platform fermentation technology
and developing the purification conditions as well as the quality controls.
This approach focuses on the delivery of GMP material in the shortest time.
The OptiTrack process development is based on optimizing
the fermentation conditions before developing the purification conditions.
This approach focuses of the delivery of GMP material with the highest yield.
