

Using our robust downstream purification platforms, Bioworkshops can develop an efficient downstream process for most mAbs and many other therapeutic proteins in weeks. We offer the flexibility to transfer, develop and optimize client-specific processes for either monoclonal antibodies and recombinant proteins, and can customize processes to meet clients’ special requests. Our goal for downstream process development is to deliver a robust, scalable and cost-effective purification process through yield optimization and product purity improvement.
Fast platform for downstream process development and standardized downstream unit operations
Intermediate depth filtration development(include membrane selection and sizing)
Column purification optimization (Affinity, IEX, SEC, HIC and Mixed Model )
In-process sample holding-time study
Chromatography resin dynamic binding capacity studies
Chromatography resin lifetime, aging and cleaning
Viral inactivation and virus clearance studies (using approved subcontractors)
Technology transfer and scale-up to support for GMP DS manufacturing
Risk analysis & Scale-down process characterization
Scale-up & Process validation

Bioworkshops Platform Process
Resin/membrane screening
Specific process parameters optimization

Using materials from 15L run
Process confirmation study
In process materials hold time study
Down-stream process development report

non-GMP and GMP run
Provide materials for toxicology studies, VC studies, reference and IND filing
provide materials for clinical trials
上海总部:中国上海市浦东新区锦绣东路2777弄2栋601室
market@biobetta.com
电话:+86 21 6165 6502 (上海)