Layer resins bring new perspective for purification

In the sector of large molecule preparation including vaccine, gene therapy and exosomes, efficient removal of impurities, while keeping high recovery and easy scale-up remains a key challenge in the development of downstream processing.

Diamond Layer mixed-mode resins, are born as a solution to this.

The working mechanism of double-layer structure

Layer resin beads consist of two parts: core bead and a porous shell:

• Core bead: highly rigid agarose beads with ligands being coupled, possessing both IEX and HIC interactions.
• Porous shell: ligand-free, function as size exclusion chromatography(SEC), control the sizes of molecules entering into pores based on molecular weights of bio-molecules.

Double-filtration mechanism’ in purification:

• Large bio-molecules(e.g. viruses, VLP, plasmid)---blocked by shell and flow through.
• Small molecule impurities----enter into pores of beads, interact with ligands and bind.

The core-shell design provides Layer resins with dual functions of SEC+chemical adsorption.

Core advantage

Compared with traditional SEC or single-mode resins, Layer resins enjoy advantages as following:

• Impurity removal via single-step operation, wide condition

• Target molecules flow through, impurities bind via HIC/IEX interaction.
• Suitable for wider range of pH and salinity, higher adaptability.

• High throughput, high efficiency

• High flow, low back pressure, no need to have high bed height (compared with SEC resin), applicable for large scale production.
• Large sample volume, adsorption of high volume of impurities, effectively cut CV and operation time.

• Stable structure, better tolerance to cleaning using common chemical reagents.

High mechanicastrength, good chemical stability, can tolerate CIP with 1M NaOH + 30% isopropano

• Better scalability

Easy to scale up from lab experiment to commercial production, shorten up production process development period.

Applications

Layer resins enjoy outstanding performance in the downstream bioprocessing:

• Vaccines for human: widely applicable to the purification of viruses, plasmid and VLPs.

• Cell and gene therapy: efficient removal of impurities from the extraction of plasmid to capture of viral vectors. A good replacement for conventional SEC resins.

• Vaccines for animal and other sectors: 90% and above recovery for PRRSv (Porcine Reproductive and Respiratory Syndrome virus ) vaccine. Suitable for extraction of exosomes from different sources, suitable for large volume feedstock, easy scale-up.

Case Study

• Inactivated COVID-19 vaccine: remove HCP and DNA via single-step purification, keep activity of antigen.

• AAV vaccine: High flow operation, shorter purification time.

• Lentivirus purification: when level of impurity is low, recovery of 60% and above is achievable via single-step purification using Layer resins.

Conclusion

Layer mixed-mode resins combine the SEC interaction and chemical adsorption, realizing efficient impurity removal and easy scale-up while ensuring high recovery of target molecules. All these provide new options for the preparation of vaccine, gene therapy and exosomes.

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