Teknova and Sartorius BIA Separations Share Data Demonstrating Reliable and Scalable Approach for the Enhancement of AAV Full Capsid Enrichment with an Optimized AEX Platform

HOLLISTER, Calif., July 20, 2023 (GLOBE NEWSWIRE) -- Alpha Teknova, Inc. (“Teknova”) (Nasdaq: TKNO), and Sartorius BIA Separations, which is part of the international life science group Sartorius, today shared new data that demonstrates the ability to improve the recovery of full AAV capsids during anion-exchange (AEX) purification, which will help gene therapy companies streamline the downstream processing workflow. Teknova is a leading producer of critical reagents for the discovery, development, and commercialization of novel therapies, vaccines, and molecular diagnostics, and Sartorius BIA Separations is a leading developer of monolith-based technologies for the separation and analysis of large biomolecules and viral particles.

Teknova presented the findings from the companies’ first collaboration earlier this week during a presentation entitled, “Enhancing AAV Full Capsid Enrichment with an Optimized AEX Platform: A Case Study." After identifying capsid enrichment as a critical pain point in the AAV gene therapy workflow, Teknova and Sartorius BIA Separations began working together to address the challenges gene therapy developers face. By using a robust design of experiments (DOE) approach, the companies were able to achieve more than 85 percent full capsid enrichment with 80-95 percent recoveries using custom Teknova buffers along with the Sartorius BIA Separations CIMmultus® QA monolith for the polishing step, given a specific starting material of AAV8 that contained 46 percent full capsids. The buffers and parameters discovered in this study were then further optimized to create a first-of-its-kind product available off-the-shelf for gene therapy developers: Teknova’s AAV-Tek AEX Buffer Screening Kit for AAV8.

“The findings from our first DOE with Sartorius BIA Separations indicate a real advantage for gene therapy development when leveraging a combination of Teknova’s proprietary reagents and BIA’s AAV monolith platform,” said Stephen Gunstream, Teknova’s President and Chief Executive Officer. “We’re committed to finding new tools to help our customers streamline the development of AAV therapies and these results illustrate how we can help accelerate the discovery of novel breakthroughs to improve the health of patients.”

“Our collaboration with Teknova has demonstrated two essential components for the successful separation of AAV empty and full capsids during the downstream polishing step: the purification platform and the buffer composition,” said Aleš Štrancar, Managing Director at Sartorius BIA Separations. “By combining our strengths, we’ve been able to consistently reproduce results that indicate the use of Teknova’s high-quality, custom buffer formulations with our CIMmultus QA monolith increases the yield and purity of full AAV particles.”

Gene therapy companies focusing on AAV8 now have a reliable and scalable option for the enhancement of AAV full capsid enrichment during the downstream purification process that could help save months in process development. Teknova and Sartorius BIA Separations continue to develop data demonstrating improvements in AAV purification, and plan to share additional findings in the future.

To see the data from the companies’ recent DOE, watch the webinar here.

Consumables used during the DOE are now available through each company’s website:

For information about Teknova’s AAV-Tek AEX Buffer Screening Kit or to purchase it online, visit teknova.com.

For information about Sartorius BIA Separations CIMmultus QA monoliths or to purchase one online, visit sartorius.com.

Teknova makes solutions possible. Since 1996, Teknova has been innovating the manufacture of critical reagents for the life sciences industry to accelerate the discovery and development of novel therapies that will help people live longer, healthier lives. We offer fully customizable solutions for every stage of the workflow, supporting industry leaders in cell and gene therapy, molecular diagnostics, and synthetic biology. Our fast turnaround of high-quality agar plates, microbial culture media, buffers and reagents, and water helps our customers scale seamlessly from RUO to GMP. Headquartered in Hollister, California, with over 200,000 square feet of state-of-the-art facilities, Teknova’s modular manufacturing platform was designed by our team of scientists, engineers, and quality control experts to efficiently produce the foundational ingredients for the discovery and commercialization of novel therapies.

Sartorius BIA Separations develops and manufactures market-leading CIM® monolithic chromatographic columns for the purification and analysis of large biomolecules, such as viruses, plasmids, and mRNA, which are applied in cell and gene therapies. The company’s Cornerstone® Biomanufacturing Development Services are the result of more than 20 years of hands-on experience with the most challenging biopharmaceutical products and offer a comprehensive approach of integrated process development solutions and novel technology designed to improve the robustness and yield of large biomolecules production while improving the safety of therapeutic products. Sartorius BIA's technology for manufacturing-scale purification is already used in the production of the first commercialized advanced therapeutics; the company also has a keen presence with novel drug candidates in the clinical pipeline.

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