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.

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Bioreactor Simulation illustration

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.

Characterize bioreact samples illustration

Read the Latest
in AAV Development and Manufacturing

Reference 1

FDA CBER Session: “Advanced Manufacturing and Analytical Technologies (AMAT) for Regenerative Medicine Therapies (RMT) Workshop, 2023”

Watch now
Reference 2

ASGCT Training on AAV Vector Biology

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Reference 3

Mol Ther Methods Clin Dev. 2016: “Manufacturing of recombinant adeno-associated viral vectors for clinical trials”

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Form Bio Resources

How a Public Gene Therapy Company Optimized Construct Design

Download Case Study

Distinguishing AAV Empty & Fragmented Capsids

Download Guide

Key Process Development Questions
Form Bio Can Help Answer

How does changing triple transfection molar ratios impact cell titer?

Are there any unexpected side products 
related to vector plasmid?

What is the ideal harvest time for 
chosen bioreactor conditions?

Why won't my vector plasmid 
express as expected?

How will the current process 
scale up to XL volume?

What questions are you interested in answering?

Schedule a Discovery Call

Key Benefits for Vector Design Teams

Simulate bioreactor runs to save time and resources, ultimately reducing COGS

Partner with us to
 influence our downstream
 purification simulations

Optimize bioreactor volume, 
molar ratios, cell density, 
harvest time

Characterize full-length AAV sequences from bioreactor runs

Accelerate development  timelines, reduce costs and improve manufacturability

FORMsightAI models are continuously validated against wet lab data with CDMO and academic partners

Learn More About What You Can Do with FORMsightAI

Product Characterization

Fully understand constructs with automated AAV characterization reporting

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Biomanfuacturing Simulation

Predict manufacturing results relating to truncations and other issues

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Comparative Analysis

Compare an array of
constructs with different design characteristics to find the most promising versions

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Generative Optimization

Enhance constructs to generate de novo designs with the best predicted yield, efficacy and safety characteristics

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Get Your Therapeutic Candidate to Market Faster

TALK TO OUR EXPERTS
Schedule a Discovery Call