Orca Bio taking inhouse approach to cell therapy with Sacramento plant

“It’s important we maintain control over the process to ensure we are meeting the highest standards of quality,” says cell therapy developer Orca as it announces a 100,000 square-foot plant.

Orca Bio’s lead product, the cell therapy Orca-T, is in Phase III clinical trials for several of the most prevalent blood cancers.

As such, the firm is looking beyond its clinical manufacturing site in Sacramento, California and is constructing a 100,000 square-foot commercial facility nearby with the capacity to manufacture approximately 3,000 cell therapy products per year.

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“The construction of this facility is part of Orca Bio’s inhouse manufacturing strategy,” a company spokesperson told BioProcess Insider.

“In cell therapy, the manufacturing is the product, meaning that the manufacturing is highly linked to the drug composition. Therefore, it’s important we maintain control over the process to ensure we are meeting the highest standards of quality when it comes to the production of our products.

While the use of third-party manufacturers is both prevalent and critical across the pharma industry, there has been somewhat of a reversal in strategy among a significant number of cell and gene therapy developers.

The complex and personalized nature of many of these products means Orca is added to companies like Allogene, AdaptImmune, and Iovance, which have lauded the benefits of having internal capabilities for their cell therapy products. Meanwhile, Regenxbio, Pfizer, and Tenaya Therapeutics, have all stressed that competition for CDMOs due to a shortage of vector production drove investments in their own gene therapy capabilities.

“We quite literally hold patient’s cells in our hands, and with that comes tremendous responsibility,” the Orca spokesperson told us.

The level of investment in the new facility has not been divulged but “like most cell and gene therapy facilities, it is a capital intensive project requiring significant investment,” they added.

“The construction began in August of 2021 and is scheduled to be completed later this year. The facility is expected to be fully validated and operational in the first half of 2023.

“We have not yet disclosed the number of employees we’ll be hiring for the new facility. But for context, today, about 50 employees are located in our current cGMP facility in Sacramento. We expect to scale that number to meet the demands of our new facility once fully operational.”

UPDATE: The original article stated Orca-T was a CAR-T therapy. Orca-T is the current name of an investigational therapy that contains a specific set of blood cells from a healthy donor. Orca-T is given to the recipient in a similar way as standard cell therapy, but unlike CAR-Ts is not genetically modified.