HALIX offers GMP mammalian cell culturing and protein production from recombinant sources
Therapeutic protein use
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.
Currently, CHO cells are the most typically used cell for GMP production of therapeutic monoclonal antibodies and other recombinant proteins.
Protein Production at HALIX
HALIX produces drug substance of therapeutic proteins and glycoproteins using mammalian cell culturing and downstream technology. CHO cell 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. If CHO is not the platform of choice, HALIX can work with alternatives for recombinant protein production such as HEK 293 cell.
Recently, biosimilars have started to replace originator molecules as they come off patent. These biologicals are carefully designed copies of blockbuster molecules which have proven to be able to generate huge revenues.
HALIX offers biosimilar production according to exacting specifications and quality standards. As biosimilars face a highly competitive market, cost reduction without quality loss is key to commercial success.
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.
HALIX Full Service Offering
HALIX is your partner for GMP bioreactor production and mammalian cell culturing of drug substance. In our BSL2 manufacturing cleanroom areas, we offer small (50 liter or less), midsize (250 liter) and large scale (1.000 liter) bioreactor capacity.
We can provide you with high quality therapeutic proteins, allowing you to proceed through clinical trial phases and move swiftly to commercial manufacturing. The provided GMP manufacturing design can be individually adapted based on the specific drug product quantity and quality needs (CQAs). Our GMP bioreactors are state of the art, using fully disposable, single use technology.
For the processing of drug substance, we use a broad spectrum of purification techniques. This includes chromatographic separation, filtration, tangential flow filtration, dead end filtration, low speed gradient centrifugation as well as virus inactivation and removal.