BIOCULT BV supply non-GMP contract manufacturing services for Monoclonal Antibodies. We conduct our operations through an independent contract manufacturing facility based in Leiden, The Netherlands. Our company was NEN-EN-ISO-9001:2008 certified in the year 2002.
BIOCULT was established in 1992 and its core business specialises in the In Vitro upscaling of immortalized cells for monoclonal antibody production and purification.
BIOCULT facilitates companies that have a lack of manufacturing capacity to achieve their targets for pilot production and the manufacture of diagnostic grade products and products for clinical (Phase 1) studies. Currently, BIOCULT only offer non-GMP services.
Reasons for using BIOCULT:
- Tailor made product with regards to both volume and price.
- BIOCULT uses Hollow Fiber Bioreactor Systems as well as other batch and perfusion systems and has successfully processed over 150 different cell lines e.g. hybridoma, transfectoma, BHK, CHO, PerC6.
- Our certified (NEN-EN-ISO 9001:2008) quality system guarantees the production of your monoclonal.
- Our Production Facility is equipped with classified “clean rooms” (class A/B/C) to meet the standards for Good Manufacturing Practices (GMP).
- Our facility is now able to support the manufacture of (Master) Cell Banks and for the production of antibodies for use in pre-clinical studies in accordance with GMP guidelines.
- BIOCULT’s R&D comprises of optimisation of culture conditions, media and serum requirements, selection of “high producers” and product purification.
In order achieve the best results BIOCULT believe in offering a personalised and flexible service to all our customers, and our clients can be assured that all projects are dealt with in full confidence.Contact
To learn more about BIOCULT's services and capabilities and how they can assist your business, please contact BIOCULT directly.
- CRO, CMO, CRAMS & CDMO
- Drug Discovery
- Manufacturing & Production