Theragent, a cell therapy contract development and management organization (CDMO) focused on advancing next-generation cancer and rare disease treatments, 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 partnership bolsters Theragent’s commitment to 100% digital batch record compliance.

“Theragent set out from the beginning with a mission to be completely paperless as a next generation pharma 4.0-enabled CDMO”, said Jeff Masten, COO of Theragent. “Theragent and Insight68’s exclusive agreement will give Theragent a profound ability to eliminate manufacturing inefficiencies and provide vein-to-vein transparency to our clients, unlike other cell and gene therapy CDMOs.”

Although 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 will be able 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.

Insight68’s platform 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.

Customized for cell and gene therapy CDMOs, Insight68’s AI-driven capabilities are embedded in a digital platform to predict and optimize inventory, manufacturing, and logistics.

The platform is fully compliant with FDA 21 CFR Part 11, GDPR, and HIPAA. All products, modules, and applications are configurable and user-friendly.

According to the company, while many CDMOs face issues with slow processes, inaccurate scaling predictions, and mistake-prone paper batch records, Insight68’s novel platform will allow Theragent to move past those challenges and provide flexible and compliant solutions that are quickly and easily deployed.