Henogen’s service offer in brief
Why is it interesting to you?
Henogen proposes to manufacture your recombinant macromolecules and viral vectors according to GMP standards in different expression systems (mammalian cells, yeasts, etc...) at a 300L pilot scale. A batch release certificate will be delivered with all the QA/QC test results with the final product.
Henogen can also help you :
- Upstream to optimise your manufacturing process: procedure transposition for production according to GMP standards: from R&D process to GMP, choice of expression system, cell line development, serum-free adaptation, media screening, (fed)-batch and perfusion processes, development and assays.
- Downstream to take care of your clinical trials up to phase III: Writing of the regulatory documents, management of phase I to III clinical trials.
- With 20 years of experience in industrial processes, Henogen, a spin-off of the ULB (Free University of Brussels), controls all the steps of recombinant macromolecule and viral vector manufacturing.
- Henogen has expertise in organizing clinical trials and writing regulatory documents.
- Henogen has in house expertise and qualification in Immunology.
- A product in phase II clinical trials has increased value for the industry.
- Henogen could partner with you from a very upstream development stage (procedure transposition) up to a very downstream stage (follow up of phase I to III clinical trials).
- You access, through only one subcontractor, to all the required services for your project, including the delivery of a complete file covering the manufacturing procedures of your clinical grade recombinant macromolecule or gene therapy vector and the results of clinical trials.
- Under mutual confidentiality agreements, Henogen includes one member of your team in the project management and execution. This is a valuable asset for your company when going from pilot to large-scale production for phase III clinical studies.
