Resources - Ascend

Rudolph Klementz, Melanie Plath, Johanna Wagner, Matthias Boscher, Jared Babic, Tatjana Fischer, Sebastian Sedlmeier, Christiane Mummert, Julia Trommer, Chris Thorne, John Betts, Ahmed Youssef

Cost effective, seamlessly scalable upstream manufacturing remains a bottleneck in adeno-associated virus production. Ascend Advanced Therapies, in collaboration with Sartorius, demonstrated a scalable upstream manufacturing platform for adeno-associated virus vectors. Using HEK293 cells, proprietary media, and the two-plasmid EpyQ® AAV Production System, consistent productivity, quality, and potency were demonstrated from 250 mL to 200 L across Ambr® 250 Modular, Univessel® SU, Univessel® Glass, and Biostat STR® bioreactors. Successful scale-up has also been achieved with a traditional triple-plasmid transfection approach. Critical quality attributes — including viral genome and capsid titers, host cell and plasmid DNA impurities, and percentage of full capsids — remained consistent across scales. Combining a standardized, fully scalable bioreactor platform with the two-plasmid approach accelerates development timelines and delivers a cost-effective, robust path from laboratory to manufacturing volumes.

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White Papers

1 May 2026

Development of a Closed-System Approach for Downstream Processing of Large Viruses: A Case Study Using Poxvirus as a Model for Preclinical and Clinical Applications

Tingting Ju, Salman Safdar, Ken Bui, Thomas Montague, Nacole Lee

Ensuring sterility during manufacture of virus-based drug products is critical for patient safety, particularly when viral particles are too large to permit filtration through standard 0.2-µm sterilizing-grade filters. Large viruses such as poxviruses require bespoke process adaptations to meet current good manufacturing practice (CGMP) standards while maintaining process integrity. The authors established a fully closed system for downstream processing of poxviruses to minimize manual intervention and contamination risk. The writers outline the design, implementation, and validation of the system, discuss associated challenges and solutions, and present key lessons learned through use of vaccinia virus as a model organism.

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White Papers

18 December 2025

Optimizing AAV Serotype Filtration with Sartoclear Dynamics®️ Lab

Sirri Ndonwi, Beatriz L Carnio, Dila Bitnel, Jared Babic, Tatjana Fischer, Matthias Boscher, Johanna Wagner, Ahmed Youssef, Benjamin Graf, Andreas Pickl

In this application note we present data showcasing the clear filtration of different AAV serotypes using Sartoclear Dynamics®️ Lab in combination with the Sartolab®️ Multistation. Clarification experiments were first optimized in 250 mL batches and further upscaled to 1 L fractions. The production of the AAV material in HEK293 cells as well as the process optimization, analytical measurements and upscaling experiments were designed and performed by Ascend Advanced Therapies, a leading CDMO for high-quality, cost-effective gene and advanced therapy development and manufacturing. The further described results show that Sartoclear Dynamics®️ Lab can be used to simplify and accelerate the process of HEK lysate clarification and allows to reduce the hands-on time for clarification by a factor of ~6x compared to classical centrifugation followed by membrane-based clear filtration.

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White Papers

7 August 2025

B L CARNIO, J WAGNER, NI BOSCHER, J BABIC, D BITNEL, T FISCHER, S NDONWI, H EL RADI, L SAVARY, C ZACH, B HAGER, S RITTER, M GORA, T KLOETZLER, M WEIDLER, A SCHOBERTH, M LANGHAUSER, M HOERER, K HELLER, A YOUSSEF

ASGCT 2025 Poster #1941

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