Downstream Development

MABION has experience in developent of downstream processes for biotherapeutics, especially recombinant antibodies. Our experienced personnel, plus our strong focus on integration of analytical and protein/process characterization methodolgies into the process development program is unique on the market.
With our experience on all the familiar and industry-wide applied purification technologies, and with some processing technologies that are less conventional but highly effective in an industrial setting, we have bioprocessing solutions to the downstream process development challenges of numerous clients.

Our downstream platform includes the following:

Antibody Processing
•    Standard Protein A-based process platforms
•    Mixed mode reisins based process platforms
•    Chromatography polishing steps, e.g. anion exchange, cation exchange,
hydrophobic interaction and hydroxyapatite
•    Membrane chromatographies

Non-antibody Proteins
•    Process development for any protein

Viral Clearance
•    Development of viral inactivation and clearance steps by three independent
methods
•    Broad experience with all avaliable viral filters
•    Viral clearance strategies, protocols and execution

Process Characterization

•    Product and process related impurities identification and clearence
•    Broad analytics during downstream process development
•    Stability assessments
•    Process ranging and robustness studies to support process optimization and
validation
•    Extensive documentation

Protein Refolding
•    Development of solubilization and refolding processes for target proteins
expressed as inclusion bodies