Ascend is the partner for AAV vector design, manufacturability, scale-up and quality assurance. From early pre-clinical phases into the clinic and out on the market, we understand that consistent product quality is not negotiable and work to get it right early on. Our team is always thinking about the scalability of a product to ensure it can have the greatest impact on the patients that need it.
Even before process development starts, we use a suite of in-silico tests to screen client vectors for problematic sequences linked to secondary structure, transgene expression and other genetic control elements.
Platform Innovation
One of our most critical differentiators is the unmatched flexibility of our technical platform solutions. Together we can conduct side-by-side comparisons of your platform operations with ours to ensure the best aspects are carried forward. Optimization of the process is then achieved using DoE methodology.
Process Development
Having a wide range of bioreactor sizes including shake flasks and stirred tank reactors, as well as Ambr15 and Ambr250 systems for design of experiment work flows and scale up verification means that we can very quickly identify optimal conditions for your AAV vector manufacturing.
Formulation
We perform high throughput and focused formulation screening to deliver the best formulation for any target product profile. High-end, low volume analytical methods and automated rebuffering decrease the AAV starting material needed. Close collaboration with the downstream processing team enables a smoother transition to manufacturing with in-use testing services to assess the suitability of preclinical and clinical dosing procedures.
Manufacturing
With the upstream process set, we can run larger bioreactors to provide you with the amount of AAV vectors you need. This could be from 2L to 10L, 50L or 200L scales, but when using our proprietary split 2 plasmid system, you can be sure that particle quality will not suffer as production scales increase. Our robust downstream processing workflows can also be tailored to your requirements.
Analytics
Producing high quality AAV vectors is only possible because we have world-leading analytics systems in place to confirm this. In addition to VG/mL and %full capsid measurements, we look at encapsidated genome length (NGS), particle aggregation, visible and sub-visible particles, potency and levels of packaged contaminant DNA (plasmid and host cell derived).
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