Theragent looks to AI as cell therapy CDMO 'game-changer'

CDMO Theragent has signed a multi-year agreement with AI-based software firm Insight68 to streamline and digitalize the cell therapy manufacturing process.

Contract development manufacturing organization (CDMO) Theragent will have access to Insight68’s digital platform to scale manufacturing while managing production schedules with customers’ clinical trial schedules, derisking delivery of treatment to patient.

Insight68’s platform has AI-driven capabilities, and the firm claims it can optimize and predict inventory, logistics, and production. Theragent said the platform tackles issues such as slow processing, inaccurate scaling predictions, and mistakes in paper batch records by providing flexible and compatible solutions that can be developed easily and quickly.

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“It is a secure, AI-driven, cloud-based platform designed for personalized therapy / cell therapy manufacturers. It provides complete chain of custody and chain of identity of patient samples, while its AI-driven capabilities predict and optimize inventory, manufacturing, and logistics to promote ‘right first time’ efficiency,” a spokesperson for Theragent told BioProcess Insider.

Additionally, Theragent says the partnership will support the company’s commitment as a Pharma 4.0 enabled CDMO by significantly reducing paper usage with an aim to becoming completely paperless. CEO of Apprentice Angelo Stracquataniois described Pharma 4.0 in April 2021 as “the intersection to connect your people, to your process, to your physical environment,” as well as new and emerging technologies.

Game changer

The CDMO will also be able to use the platform to coordinate manufacturing schedules with customer clinical trial schedules. In turn, the firm says this reduces the risk of on-time delivery of treatment to the patient.

Insight68 will provide training on each output or product for Theragent’s workforce, and operations will take place at the CDMOs cell therapy facility in Arcadia, California.

“This partnership is driven by our company’s strategic initiatives to reduce documentation errors, decrease delivery time of our therapeutics to patients, and fully integrate our operations with clinical trials scheduling,” said Jeff Masten, COO of Theragent.

“For example, once a patient’s T cell samples are collected and sent to Theragent for processing, we can provide direct feedback to the treating physician as to when they can expect to receive that patient’s CAR-T dose. Additionally, our clients who are sponsoring the clinical trial can see the progress of each therapeutic batch we are producing for them through an online portal, which aligns with our core value of transparency. We believe this is a game changer for our CDMO.”