Process Development
USP & DSP
Integrated Upstream and Downstream Processes for yield-maximisation of biologics. With desired quality, purity and scalability.
Upstream Process Development
And Manufacturing
Mammalian-based upstream process development, optimization and characterization in controlled bioreactors
Seamless and straightforward USP process, scaleup from small bench scale up to 250 L scale of operation.
Protein production from 3L STR up to 250L STR, based on transient transfection process, stable pools or stable clones from both CHO and HEK 293 cells.
Generation of purified material to support client’s development program: from mg to kg of purified protein to support e.g. lead candidate optimization, analytical development, formulation development, execution of toxicologic studies and more.
Preparation of extensive process development report and final process description to facilitate upstream process tech transfer.
Protein material production for IND-enabling Tox studies (> 1.5 kg of purified protein).
Downstream Process development and manufacturing
Optimization and characterization tailored to your specific project needs
From simple purification with one single chromatography step to fully optimized process, intended for industrial manufacturing, based on multiple chromatography steps (affinity, IEXs, HIC, SEC) with viral inactivation and viral filtration step to satisfy any client’s requirement.
Scale-down model development and validation, and viral clearance study.
Cutting-edge technologies and approaches together with know-how and experience for robust, scalable, cost-effective processes, characterized by high protein yield (≥ 75%) and desired protein purity (≥ 99.8%).
Process development and protein purification for both tag-containing and tag-free proteins.
Seamless and straightforward DSP process scale-up from small bench scale up to 200 L scale of operation.
Protein purification from few milligrams (mgs) up to several kilograms (kgs) based on transient transfection process, stable pools or stable clones.
Generation of purified material to support client’s development program: from mg to kg of purified protein to support e.g. lead candidate optimization, analytical development, formulation development, execution of toxicologic studies and more.
Protein material purification for IND-enabling Tox studies (> 1.5 kg of protein).
Preparation of extensive process development report and final process description to facilitate downstream process tech transfer.