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. 

QUALITY SYSTEMS

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 >>

PROCESS DEVELOPMENT OF MABS

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 >>

CLINICAL MANUFACTURING OF MABS

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 >>