HALIX offers GMP mammalian cell culturing and protein production from recombinant sources
Therapeutic proteins are one of modern medicines most powerful inventions. They are used to treat a great variety of clinical indications (e.g. cancers, autoimmune disorders, infectious agents and genetic disorders). Protein based therapeutics meet unmet medical needs and improve standard of care therapies.
The first therapeutic proteins were extracted from the bodies of animals and humans or made in fermentation by utilizing naturally producing microorganisms. Modern biopharmaceuticals are typically made using bacterial or mammalian cell culture and GMP bioreactor technology.
The Process of Protein Production
The process of protein manufacturing is highly challenging and specialized. Bioreactor based cell culturing requires tight control of all factors that may influence the yield, the quality or the potency of the produced drug substance. Proteins are generated through expression of transgenes in well characterized cell platforms.
HALIX has expertise in protein production using different cell types:
Mammalian cells (e.g. CHO and HEK 293 cell production)
Protein Production at HALIX
HALIX provides small to large-scale protein expression and purification services for recombinant proteins. We can produce therapeutic proteins such as antibodies, intercellular enzymes, other hard-to-express proteins and cytokines to support your clinical studies using mammalian cell culturing and downstream processing of CHO cells.
In our BSL2 manufacturing cleanrooms the bioreactor capacities are:
Small capacity up to 50 liter or less
Midsize capacity up to 250 liter
Large scale up to 1.000 liter
HALIX Full Service Offering
Outsourcing to HALIX, a dedicated Contract Development Manufacturing Organization (CDMO), increases first time right production and speeds up the market entry while minimizing operational costs, and ensuring high quality. Protein production at HALIX is very efficient and can reach high product titers. With our expertise we keep costs manageable, timelines tight and ensure a safe and well defined final product.
Therefore, our full service offering includes:
High quality therapeutic proteins
A swiftly move through clinical trial phases to commercial manufacturing.
Individual adapted GMP manufacturing design based on the specific drug product quantity and quality needs (CQAs)
State-of-the-art GMP bioreactors, using fully disposable, single use technology
The culturing process can be performed in shaking or stirred bioreactor systems.