FORM BIO FOR PROCESS DEVELOPMENT
Scale-Up for Higher Yield and Lower COGS
Reduce your AAV gene therapy cost of goods (COGS) and optimize process development with in silico bioreactor simulations.
Optimize Bioreactor Runs in silico
Running an AAV construct through a bioreactor can be highly unpredictable. Using Form Bio’s in silico methods, process developers can quickly simulate the impact of changing triple transfection molar ratios, bioreactor volume, HEK cell density and harvest time. This process enables the identification of optimal conditions for bioreactor scale-up. By doing so, process developers gain deeper insights into the effects of these iterations on crucial factors, such as resulting viral genome and capsid titer, empty/fill capsid ratios and other critical quality attributes (CQAs). These in silico methods have been replicated and validated on existing literature data.
Characterize Bioreactor
Samples with Confidence
While essential for optimizing rAAV bioreactor runs, integrating long read sequence data remains uncommon among drug companies. In collaboration with PacBio, we’ve created an end-to-end workflow that combines HiFi sequence data with AI technology, in order to reveal hidden issues that may affect gene therapy’s safety, efficacy and manufacturability. Researchers are able to pinpoint fragmentation and truncation issues, verify desired transcript expression and detect impurities and host events. This instills process confidence for seamless transition to GMP manufacturing.
