HALIX uses a BSL2 facility for mammalian cell culturing in (fed-)batch and perfusion single-use bioreactors. Our capabilities cover both recombinant proteins (including antibodies), and viral vectors/vaccines. The controlled GMP environment offers two independent culturing suites and a downstream processing and purification suite.
We can perform batch, fed-batch or perfusion culture manufacturing GMP processes. We base this on your manufacturing design, desired drug product quantity and specific quality needs (CQAs). The process is implemented in close cooperation with you.
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.
HALIX is specialized in production of viral vectors and viral vaccines (both live and inactivated).
HALIX’ production facility supports flexible production scenarios. HALIX can provide adherent cell based and suspension cell based processes. Viral vector purification can be performed by classic ultracentrifugation based processes or state-of-the-art and scalable chromatographic processes.
HALIX performs aseptic filling and lyophilization activities in class A clean room conditions. We use the automated filling line with validated vial sizes of 2RDIN, 6RDIN, 10RDIN, 15RDIN and 50ml.
Our freeze dryer has a capacity of 5.2 m2, which can lyophilize up to 20.000 vials per batch. The freeze dryer has a vial plate surface of 5.2 m2.
In line with EMA requirements for injectables, 100% of the vials are subject to a visual inspection. Our operators are qualified for the visual inspection of suspensions and clear solutions, using polarized light.
Cell banks (MCB/WCB) and Seed Banks (MVS/WVS)
HALIX offers production, safety testing and characterization for master- and working cell banks and master- and working virus seed banks. The banks and seeds are produced in our GMP clean rooms using roller bottles or cell factories. After harvesting, the product is filled in cryo-vials and stored frozen in our vapour phase liquid nitrogen storage.
Tech and TOX Batch Manufacturing
HALIX performs upscaled production for evaluation of technological capabilities. We use tech batches as a step before GMP production, to make sure the process is well controlled and well executed.
In order to determine the toxicological profile of a product the manufacturing of a TOX batch is a necessary step in the development of biopharmaceutical products. HALIX can upscale the current production to deliver material for use in toxicological studies.
We also provide regulatory support in the pre-clinical phase, by assisting you in dossier development pre-IND and IMPD.