Theragent commits to 100% digital batch record compliance as it teams up with AI software firm: ‘This will elevate our reputation as a leading CDMO’

By Jane Byrne

- Last updated on GMT

© GettyImages/Vertigo3d
© GettyImages/Vertigo3d

Related tags AI Cell therapy Artificial intelligence CAR-T CDMO

California based, Theragent, a cell therapy CDMO, has signed a multi-year exclusive contract with Insight68, an AI-driven software provider that aims to digitalize and streamline the cell therapy manufacturing process.

The company said the partnership reinforces Theragent’s commitment to 100% digital batch record compliance and elevates its reputation as a leading CDMO in the current biopharma manufacturing transformation.

The deal with give it a profound ability to eliminate manufacturing inefficiencies and provide vein-to-vein transparency to our clients, which it said is not the case with many other cell and gene therapy CDMOs.

“While many manufacturers still largely rely on paper records, Theragent will bypass both paper and paper on glass records and move straight to digitalized records, which can be tracked in real-time in a fully transparent manner.”

In addition to significantly reducing paper usage, Theragent said the partnership will enable it to accurately scale production while coordinating production schedules with the sponsor’s clinical trial schedules, thereby de-risking on-time delivery of treatment to the patient. The AI-based platform also fully automates Theragent’s ordering, production planning, scheduling, and execution processes, while giving each client real-time access to batch runs. In addition to electronic batch records, Insight68 will provide Theragent with cGMP electronic equipment use, facility cleaning e-logbooks, and electronic lab notebooks.

Additionally, the platform provides complete chain of custody and chain of identity of patient samples, offering transparency to sponsor clients, said the CDMO.

‘A game changer’

Theragent's COO, Jeff Masten, said the tie-up with Insight68 is a game changer for the company:

"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. 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.”

When asked whether Theragent believes the CDMO sector has been somewhat of a laggard when it comes to adoption of pharma 4.0 linked ​technologies, and digitalization models, a spokesperson told BioPharma-Reporter: “In the past, CDMO investments have been rightfully focused on capacity - namely capital expenditures such as clean rooms and process equipment - at the expense of Pharma 4.0 digitalization. Automation investments were focused on standard yet unlinked ERP and MES platforms.

“In contrast, from the beginning Theragent believed that it could stay ahead of the curve by not only providing manufacturing capacity, but by empowering that capacity with a fully paperless platform whose AI-driven capabilities predict and optimize inventory, manufacturing, and logistics to promote ‘right first time’ efficiency.”

In terms of whether it sees contract development and manufacturing organizations (CDMOs) becoming more digitally integrated with their originator clients, the representative said: “Theragent believes it is a ‘must,’ particularly for cell and gene therapy CDMOs that produce small-batch or even personalized-batch therapeutics.”

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