Next generation process development

Stop Experimenting. GoSilico.

Monoclonal antibody in blue setting

This publication summarizes successful case studies and application examples of ChromX.

WHEN THE DOE FAILS

In this case study, a high-capacity cation-exchange resin was used. The target component was an intermediately eluting antibody. One low molecular weight (LMW) and two high molecular weight (HMW) species were to be removed. All simulations, parameter estimation and process optimization were performed with GoSilico’s software ChromX.

While the impurities are hardly visible in the chromatogram (right), an SEC fraction analysis (bottom) shows that the LMW impurity strongly overlaps with the target antibody such that LMW removal would result in less than 70% yield.

Protein in blue setting

FROM BATCH-WISE TO CONTINUOUS PRODUCTION

As fully integrated continuous processing is being adopted by the biopharmaceutical industry, the individual batch-wise processes have to be replaced by continuous equivalents.

Periodic counter-current chromatography (PCCC) systems are able to cope with ternary mixtures. PCCC has been successfully employed as first capture step and design charts have been developed for such cases by Carta and Perez-Almodovar. However, intermediate IEX purification steps are much more sensitive to small changes in the process parameters.

Virus VLP in blue setting

MEMBRANE CAPTURE FOR A VLP

VLPs are composed of multiple copies of recombinantly produced viral structural proteins which assemble into empty particles.They can either mimic the structure of viruses or present epitopes of foreign pathogens or tumor cells on their surface. Process development for VLPs is a complicated task, as there are no platform process available, yet. Mechanistic modeling can be used to efficiently identify optimal process conditions.

This poster was presented at the following conferences:

  • 12th European Symposium on Biochemical Engineering Sciences (ESBES) ; 09/2018; Lisbon, Portugal
  • 31st International Symposium on Preparative and Process Chromatography; 07/2018; Baltimore, Maryland, USA
  • BioProcess International European Summit; 04/2018; Amsterdam, Netherlands

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