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Understanding the Impact of Osmolality on Upstream AAV Manufacturing

The Importance of Osmolality in the Cell & Gene Workflow

Osmolality, a measure of solute concentration, is a critical attribute in the bioprocess workflow, whether one is manufacturing therapeutic antibodies or in the production of viral vectors for use in Cell & Gene Therapy applications. Understanding the osmolality of solutions used in each step provides critical information on culture conditions, material quality at each step of purification, and final formulation composition.

AAV Upstream Process Study Conducted by Cell & Gene Therapy Catapult

The Advanced Instrument (AI) and CGT Catapult collaboration focused on three projects that were focused on understanding the impact of osmolality on AAV1 upstream manufacturing.

Project one focused on determining the impact of osmolality on transfection efficiency, using an array of markers including, Cell viability, transfection efficiency, daily metabolites (glutamine, glucose, lactate, and ammonia), and osmolality using the AI OsmoTECH®PRO technology. Viral genome (Vg) and Capsid titers were assessed at 72 hours post-transfection.

Project two assessed the use of osmolality as a decision tool to trigger a feeding regime during AAV1 manufacturing, while project three focused on the scale-up and use of osmolality to inform optimal time of harvest. The final project in the collaboration utilized the Cell and Gene Therapy Catapult suspension-based platform and benchmarked against optimal parameters identified in the first two projects at a 250ml scale using the Ambr®250 system. The same parameters were assessed as previously mentioned, and the data portrayed in the graphs found on this site.

What Is The Cell and Gene Therapy Catapult?

The Cell and Gene Therapy (CGT) Catapult was established in 2012 as an independent center of excellence to advance the growth of the UK cell and gene therapy industry by bridging the gap between scientific research and full-scale commercialization. With its focus on cell and gene therapy technologies, CGT Catapult works with partners in both academia and industry. CGT Catapult offers a full range of capabilities with state-of-the-art technologies to enable companies to take products into clinical trials. The CGT Catapult works with Innovate UK. For more information, go toct.catapult.org.ukor visitwww.gov.uk/innovate-uk.

Cellular therapy. 3d illustration

病毒载体基本提高质量与产量ring Using Osmolality: Unveiling Exciting New Data from Cell Gene Therapy Catapult

In this on demand presentation, you will hear the latest fromKendal Studd of Advanced Instrumentsabout the range of ways in which osmolality can improve efficiency and recovery within the CGT manufacturing process both for AAVs and Lentiviruses.

Dr. Adrien Soula of the Cell and Gene Therapy Catapult将全新的数据研究完成in June 2021 that showed a significant increase in yield and quality of an AAV resulting from a timed osmolality shift. Additionally, his data will show how the shift had a profound effect on the relative extracellular vs. intracellular vector yield with exciting implications.

Lucia Marani from Oxford Biomedica’s Analytical Development teamwill discuss their recent and innovative use of osmolality as a product stability indicator, further augmenting its commonly adopted use for formulation and QC applications.


Interested in learning more about this data?

Request a meeting with our expert scientific staff now for an overview of this study. Gain insight into the importance and relevance of osmolality in the bioproduction workflow and how this data could improve your AAV manufacturing.

Interested in learning more about our technology?

Request a virtual demonstration of the instrument used in this study with our team today!

Mark Rothenberg, Ph.D.
Associate Director, Scientific Applications

Optimizing Viral Vector Production and Efficiency While Saving Potential Costs with Osmolality (Poster)

This scientific poster presents data from a study done in collaboration with the Cell and Gene Therapy Catapult, completed in June 2021. It shows that a significant increase in yield and quality of an AAV was realized from a timed osmolality shift.

Coming Soon!

Available soon, an in-depth application note detailing the methods, data, and findings of this study, as well as how you can increase your AAV yield and quality while potentially saving time during your manufacturing process. Learn the methods and details behind this captivating study as well as where this new application can plug into and make an immediate impact on your workflow.

Streamlining YourProcessesand Workflows:
The instrument used to complete this study

Designed to meet the high sample throughput, regulatory compliance (including 21 CFR part 11), and data management needs of busy bioprocessing and biomanufacturing labs, the OsmoTECH PRO Multi-Sample Micro-Osmometer combines ease-of-use with accurate and precise osmolality measurements for reliable and reproducible results. Optimize and ensure the quality and consistency of buffers, media, product, excipients, and process parameters to maximize biologic yield, quality, and purity.

Interested in being on the forefront of scientific discovery?

We are actively looking for partners to help support projects that will drive new and exciting applications for the use of osmolality in the bioprocess workflow.

Work with us to find ways to develop data that not only has the potential to improve your workflows and manufacturing processes, but also serve as a powerful piece of content that can be turned into captivating whitepapers or presented at conferences to increase your company’s exposure.

Contact us today and see how we can support your scientific studies.