BIOCULT - Monoclonal Antibody Contract Manufacturing

BIOCULT BV is a leading contract manufacturing company, offering a range of manufacturing services for monoclonal antibodies. We are ISO NEN-EN-9001:2000 certified and are operating a small independent contract manufacturing facility in Leiden, The Netherlands.

BIOCULT helps companies with a shortage of manufacturing capacity to meet their pilot production needs, establishing cell banks and manufacturing the product for clients (Phase I studies) in accordance with cGMP guidelines.

MONOCLONAL ANTIBODY OUTSOURCING

As an independent outsourcing partner, BIOCULT can advise on your own manufacturing processes, storage, and cell bank testing. Our focus is on production of small to medium size batches in the 1g to 25g range, with the possibility of upscaling to batches of 100g or more. If you have a temporary issue with production, then we can help!

CELL CULTURE TECHNOLOGY

Cell culture technology has proven over the years to be a robust and suitable technology for the production of pharmaceutical grade proteins. Especially for in vivo studies, cell derived proteins behave more 'naturally,' e.g. produce the correct glycosilation pattern with a higher efficacy, compared with other production systems using bacterial or yeast cells.

MONOCLONAL ANTIBODY MANUFACTURING SERVICE TAILORED TO THE CLIENT

BIOCULT has successfully processed over 100 different cell lines, using various batch and perfusion systems, and hollow fiber bioreactor systems. Our cell lines include:

• Hybridoma
• Transfectoma
• BHK
• CHO
• PerC6

Because our methods are flexible and we command international resources, we can respond quickly to your contract manufacturing needs for monoclonal antibodies.

Our production facility is equipped with certified cleanrooms (class A/B/C) to meet our cGMP standards.

MASTER CELL BANKS AND CLINICAL GRADE ANTIBODIES

Our manufacturing facility is now suitable for master cell banks according to cGMP guidelines. It is also suitable for the preparation of pre-clinical grade antibodies for use in pre-clinical studies.

MONOCLONAL ANTIBODIES - CONTRACT RESEARCH SERVICES

If your cell is not yet an optimal producer, we can also provide contract research. Our R&D expertise includes optimisation of culture conditions, media and serum requirements, selection of 'high producers' and product purification.

CLIENT RELATIONSHIPS

In order to develop lasting relationships with our contract manufacturing clients, BIOCULT seeks to know all its clients on a personal basis and fully understand their project needs. This enables a free flow of information and attains optimal project results.

Needless to say, we handle all our contracts with the utmost discretion. Please do not hesitate to contact us to discuss how we can assist you with your monoclonal antibody production or research needs.