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Improving mAb capture productivity on batch and continuous downstream processing using nanofiber PrismA adsorbents.

Ryan R Davis1, Fletcher Suber1, Ian Heller1

  • 1Ology Bioservices, Process Development, 13200 NW Nano Ct., Alachua, FL, 32615, USA.

Journal of Biotechnology
|June 12, 2021
PubMed
Summary
This summary is machine-generated.

Continuous chromatography using cellulose nanofibers significantly boosts biotherapeutic agent purification productivity and lowers costs. This advancement addresses upstream process gains, enabling efficient monoclonal antibody capture and high-throughput purification.

Keywords:
Continuous chromatographyMonoclonal antibodyNanofiberProcess intensificationProductivityPurification

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Area of Science:

  • Biotechnology and biopharmaceutical manufacturing
  • Downstream processing and purification technologies
  • Protein chromatography and separation science

Background:

  • Upstream bioprocessing advancements have increased titers, creating a bottleneck in downstream purification of biologics, particularly monoclonal antibodies (mAbs).
  • Traditional batch chromatography methods face limitations in meeting the growing demand for efficient and cost-effective purification.
  • Continuous chromatography offers potential advantages such as automation, reduced labor, and improved product consistency.

Purpose of the Study:

  • To enhance productivity and reduce costs in both batch and continuous purification processes for biotherapeutic agents.
  • To evaluate the performance of cellulose nanofibers functionalized with a Protein A ligand for monoclonal antibody capture.
  • To develop a scale-down model for high-throughput purification using periodic countercurrent technology.

Main Methods:

  • Utilized cellulose nanofibers functionalized with a Protein A ligand for purification.
  • Employed periodic countercurrent technology with multiple column chromatography setups.
  • Developed and validated a scale-down model to predict high-throughput purification performance (grams of mAbs/day).

Main Results:

  • Achieved over 30-fold higher productivities compared to traditional resin-based chromatography using cellulose nanofibers.
  • Demonstrated the efficiency of smaller columns enabled by convective mass transfer and faster processing times.
  • Successfully developed a scale-down model capable of achieving high throughput purification.

Conclusions:

  • Cellulose nanofibers with Protein A ligand offer a significant improvement in productivity and cost-effectiveness for mAb capture.
  • Continuous chromatography, particularly using periodic countercurrent technology, is a viable strategy to manage increased upstream titers.
  • These advancements are crucial for the evolution of downstream operations towards more efficient and economical biologic manufacturing.