TxCell to continue improving Ovasave production network post-suspension

09-Mar-2016 - Last updated on 12-Dec-2023 at 15:56 GMT

Image: iStock/jarun011

New facilities and a successful CMO tech transfer have helped turnaround the manufacturing of cell therapy product Ovasave, says TxCell after production was suspended last year.

In June last year, T cell immunotherapy developer TxCell suspended operations at its plant in Besancon, France, after the French regulator ANSM (Agence nationale de sécurité du medicament) raised concerns about the potential of microbial contamination.

The firm contracted Belgian CMO MaSTHerCell to make the therapy, and last month announced the initial test batches had been completed. Concurrently, the firm announced it had set up manufacturing process development laboratories and a technology transfer academy at a site in Sophia Antipolis, France.

And according to Miguel Forte, TxCell’s Chief Operating Officer, the firm “is continuing to improve the manufacturing process of its platform ASTrIA in order to reduce production time and cost and increase automation of the process,” though – he told Biopharma-Reporter – this will require “new and additional technical solutions and equipment.”

Hybrid autologous model

Ovasave is the firm’s lead candidate for the treatment of Inflammatory Bowel Disease (IBD) produced using the peripheral blood of patients and TxCell’s ASTrIA (Antigen Specific Treg for Inflammation and Autoimmunity) cellular immunotherapy product platform.

The platform “educates” antigen-specific regulatory cells (Ag-Tregs) from the patient’s own blood sample to target autoimmune inflammatory diseases. Harvested white blood cells are taught to recognise disease targets, multiplied by TxCell and then reinjected into the patient.

“From a single blood collection the manufacturing process of Ovasave delivers multiple doses allowing for chronic treatment of that specific patient,” Forte said. “This represents what is described as a hybrid autologous model, since a single batch, once produced, provides off-the-shelf multiple treatments for that specific patient.”

He added that Ovasave has a stability of at least five years when frozen.

Japan

In related news, Ovasave is on the verge of being granted a key patent in Japan in relation to its application to inflammatory bowel disease (IBD), TxCell announced yesterday.

The patent which has already been granted in the US, Australia and Russia, covers the administration of a composition that consists of at least one human Type 1 Treg cell population directed against a food antigen from the common human diet.

“The grant of this latest key patent in Japan will help to achieve TxCell’s ambitious objectives in expanding our global reach,” said CEO Stéphane Boissel.

“In addition, TxCell has dedicated years of effort in research and development to establish a robust international intellectual property portfolio. This patent coverage will be critical for our ongoing efforts to make cellular immunotherapies available to the large number of patients with a variety of conditions with unmet medical need.”