CMO - Clinical Manufacturing of Monoclonal Antibodies

BioVolutions is a Clinical Manufacturer of therapeutic monoclonal antibodies (Mabs) from gram to kilogram quantities. Thanks to BioVolutions' innovative continuous biomanufacturing solutions we can manufacture GMP-compliant, high quality monoclonal antibodies faster and cheaper than traditional fed-batch production methods. We can provide clinical as well as research grade material and will work with you from development to clinical manufacturing in a timely fashion. 


BioVolutions quality systems are accredited

Our quality systems encompass two main areas: Quality Control and Quality Assurance. BioVolutions quality systems are accredited by the authorities according to 21CFR Parts 210 and 211 and ICH guidelines. Learn more >>


Cell culture development process

During cell culture process development, continuous biomanufacturing conditions are studied and optimized to determine the effects of multiple variables on growth and viability, specific productivity , protein yields, capture chromatography, filtration and impurity levels. Learn more >>


Our facility uses flexible disposable equipment


The modular concept of the facility using flexible disposable equipment in Alternating Tangential Flow (ATF) Continuous Perfusion mode synchronized to Continuous Protein A purification  (Patent Filed) allows an order of magnitude faster production runs and an order of magnitude smaller equipment footprint compared to conventional fed-batch systems. The Clinical Manufacturing platform at the 1kg protein production level is available in skid format for easy deployment around the world.  Learn more >>