June 4, 2018
Lacking the resources to manufacture in-house, French biotech firm TxCell has chosen Lonza to produce its HLA-A2 CAR-Treg cellular product, TX200.
In February, TxCell finalized its manufacturing process to make Tx200, and began transferring tech to its contract manufacturing organization (CMO). Now the French biotech has revealed the CMO is Lonza, which will manufacture clinical batches of the CAR-Treg product from its production site in Geleen, the Netherlands.
TxCell CEO Stephane Boissel told Bioprocess Insider Lonza will produce Phase I/II materials in low volumes to begin with.
A chimeric antigen receptor (CAR) Treg therapy is made in a similar way to a CAR-T cell therapy, he explained, except during the isolation process which is selected from a very well-defined cell population.
“Importantly, incoming (leukapheresis) and outgoing (drug product) materials are frozen, which ease the logistics.”
The decision to go with a CMO came down to a lack of in-house capability, Boissel said. “We do not have the resources to manufacture on-house currently.”
And while TxCell made several requests for proposal (RFP) to CMOs in Europe and the US, the decision to pick Swiss firm Lonza came down to its “highly successful track record in manufacturing cell and gene therapies, including CAR-T.”
TxCell’s own manufacturing history has not been smooth sailing. In 2015, TxCell closed its pilot manufacturing facility in Besançon, France after European regulators found poor quality controls and deviations related to mold contamination during production of investigational batches.
The site had made the firm’s former lead drug-candidate, Ovasave, intended to treat Crohn’s disease. TxCell since reviewed its manufacturing strategy and inked a deal with CMO MaSTherCell for the production of Ovasave.
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