Cell Line Development Cell Culture Purification Formulation Analytical Development
Home / Development / Purification
Purification
Purification

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.

Services

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

Downstream Workshops

  • 8~12 weeks

    Process Development & Optimization

    Bioworkshops Platform Process

    Resin/membrane screening

    Specific process parameters optimization

  • 2~4 weeks

    Process Confirmation

    Using materials from 15L run

    Process confirmation study

    In process materials hold time study

    Down-stream process development report

  • ~12 weeks

    Pilot Scale Manufacturing

    non-GMP and GMP run

    Provide materials for toxicology studies, VC studies, reference and IND filing

    provide materials for clinical trials