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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

  • Scale-up & Process validation

  • Risk analysis & Scale-down process characterization

  • Technology transfer and scale-up to support for GMP DS manufacturing

  • Viral inactivation and virus clearance studies (using approved subcontractors)

Case Study

Due to the structure and impurities of bispecific antibodies are more complicated, the experience of downstream purification technicians and the company's platform technology are more critical. A full understanding of the structural characteristics of BsAbs and its major impurities can help to develop effective purification process. Our unique platform process and technicians with extensive experience in the development of BsAbs help our clients in the whole process of biopharmaceutical development. Our goal is to deliver a robust, scalable and cost-effective purification process for our clients by optimizing yields and improving product quality.

  • Sample:

    BsAb, Fraction from Protein A, 16mg/ml

  • Equilibration buffer :

    50 mM NaAc-HAc, pH 5.5

  • Flow rate:

    35 ml/min

Background:

The case demonstrates a process to improve the purity of BsAbs by mixed-mode chromatography.

The purity of the sample before purification was 91.5%. Based on the extensive experience of the purification process development team and the unique platform process of BWKS, the purity of the sample was improved to 99.3% (Detection by SEC-HPLC) after process optimization.

  • Sample:

    BsAb, Fraction from Protein A, 13mg/ml

  • Equilibration buffer :

    50 mM NaAc-HAc, pH 5.5

  • Flow rate:

    5 ml/min

Background:

The case demonstrates a process to improve the purity of BsAbs by CEX.

The purity of the sample before purification was 87.4%. Based on the extensive experience of the purification process development team and the unique platform process of BWKS, the purity of the sample was improved to 99.0% (Detection by SEC-HPLC) after process optimization.

Downstream Workshops

Step 1

8~12 weeks

Process Development & Optimization

Bioworkshops Platform Process

Resin/membrane screening

Specific process parameters optimization

Step 2

2~4 weeks

Process Confirmation

Using materials from 15L run

Process confirmation study

In process materials hold time study

Down-stream process development report

Step 3

~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

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