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Form Bio Announces AI Solution Set for Predicting and Optimizing Cell and Gene Therapy Manufacturability

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Form Bio has announced the launch of FORMsightAI – a new, AI-based solution set for predicting and optimizing manufacturing outputs of cell and gene therapy constructs. Form Bio FORMsightAI is generally available to cell and gene therapy companies as well as CDMOs.

Form Bio FORMsightAI is a full service solution that incorporates advanced, customizable AI models, Form Bio’s underlying platform and the company’s experienced team of computational life sciences professionals with expertise spanning biology, bioinformatics and data science.

FORMsightAI addresses common issues faced by cell and gene therapy developers of construct truncations and manufacturing contaminations, which are key contributors to unsustainably low manufacturing yields, delayed times-to-market and therapeutic safety issues. Using patent-pending large language models, in conjunction with the Form Bio platform, cell and gene therapy developers can now, for the first time, predictively analyze and avoid key manufacturing risk factors before scaling up manufacturing.

“Nearly every cell and gene therapy company we talk to faces the extremely challenging issues of capital burn, time-to-market and cost per dose. But few of them, until now, have been able to fully recognize the staggering costs of underaddressing manufacturing issues at the earliest stages of therapy development,” said Andrew Busey, co-founder and co-CEO for Form Bio. “Now, with our FORMsightAI solution, cell and gene therapy companies can not only measure this multi-billion dollar problem, but also minimize it,” he added.

The FORMsightAI offering is comprised of two core components:

  • FORMsightAI SIMULATE for predicting key metrics of bioreactor run outputs including capsid fill statistics, truncation propensities, regional truncation contribution and more.
  • FORMsightAI OPTIMIZE for generating an optimal payload construct design with the ideal predicted capsid fill metrics, full reads and minimized truncations.

By utilizing FORMsightAI solutions, cell and gene therapy companies, as well as CDMOs, can recognize these powerful benefits:

  • Reduce manufacturing costs by simulating the therapeutic output of a construct before spending millions of dollars on bioreactor runs.
  • Reduce time-to-market by minimizing manufacturing trial-and-error relating to identifiable construct contamination propensities.
  • Improve safety by predicting and optimizing capsid fill rates before expending time and resources on test production.
  • Extend IP protection by filing fresh patents on newly optimized constructs generated by FORMsightAI.

In addition, a publicly traded gene therapy company has used the solution and was able to predictively reduce truncations of one of its candidates by 70% and increase full reads by 18%.

“As a customer, we are thrilled with the uniquely valuable AI-driven insights Form Bio has contributed to our research and development efforts,”said Jenny Marlowe, Chief Scientific Officer for Solid Biosciences. “By working closely with Form Bio’s world class team and cutting edge technology, we can clearly see that applying innovative AI solutions to pre-clinical cell and gene therapy development offers exciting potential for CGT companies’ economics, market timing and ability to impact human health,” she added.