Theragent, a cell therapy CDMO focused on advancing next-generation cancer and rare disease treatments, 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. This partnership reinforces Theragent’s commitment to 100% digital batch record compliance and elevates the company’s reputation as a leading CDMO in the current biopharma manufacturing transformation.
“Theragent set out from the beginning with a mission to be completely paperless as a next generation pharma 4.0-enabled CDMO”, says 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.” 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 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.
Tailored 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. 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.
Theragent is an advanced therapeutics Contract Development Manufacturing Organization in Arcadia, CA, focused on novel cell and gene therapies for the treatment of cancer and rare diseases. The company’s innovative cGMP facility offers comprehensive end-to-end manufacturing and in-house testing capabilities for clinical and commercial purposes. With an emphasis on quality, safety, and manufacturing, Theragent strives to provide value-added solutions for clients with challenging pre-clinical and clinical trial projects.
Theragent. Patients are waiting. For more information, visit www.theragent.com.
Insight68 is an innovative AI-driven platform that drives digital transformation and scales to meet all your logistical needs. Digital transformation is the result of enhancing traditional manufacturing processes with new advancing technologies, driving manufacturing forward and addressing inefficiencies. We embed advanced analytics to help manage key aspects of manufacturing, such as inventory, consignments, production scheduling, and more. Our team has over 25 years of experience delivering innovative regulatory compliant software products for manufacturers. Our products are designed for industries such as Cell and Gene Therapy manufacturers. For more information about Insight68, visit our website at www.insight68.com.
Brian Misiner, Head of Business Development at Theragent
Shari Makishima, CEO of Insight68