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A company founded last year is hoping to tackle a major problem in gene therapy—the failure of therapies to reach the marketplace due to production failures. Bespark*bio, whose CTO Dieter Palmberger, PhD, spoke at the Terrapinn conference on Advanced Therapies earlier this year, aims to provide process development support to companies without their own internal expertise. “All three founders have worked in process development for many years at previous companies,” says Matthias Müllner, PhD, CEO of Bespark.

“And we identified a large gap in the market [helping] companies that don’t have these resources [in house].” Bespark’s approach is to help companies develop an efficient manufacturing process as early as possible in development. This includes identifying process parameters critical to product quality.



“[Many times] people do lots of experiments and then realize they need to redo them,” Müllner explains. “We try to avoid that upfront—before people get to the lab.” The team says they adopt a Quality by Design (QBD) approach, identifying unit operations for each stage of the client’s process, and then use virtual simulations to model these steps.

Some of their upstream and downstream process steps, he says, are prebuilt to be applied to new projects. The company also offers consultancy services on how to ensure product quality meets requirements in the preclinical and clinical stages. According to Müllner, their approach is very new.

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