Tackling Manufacturing Failures for Viral Vectors

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.”

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. “There are maybe only a couple of companies who provide 1-2-1 process development,” he says.

Companies in the data modeling field, he says, typically supply machine learning tools for gene therapy developers to implement themselves—which can be challenging for companies without in-house expertise.

CDMOs, meanwhile, often work on pre-existing processes, rather than helping in early development. For this reason, he says, Bespark*bio is now partnering with CDMOs to help companies reach the manufacturing stage.

“It’s a complement of services,” says Müllner.

At the Terrapinn conference, Palmberger presented a case study from the founders’ previous roles where they used QBD, scoping experiments, and a digital twin to assess how many unnecessary experiments could be avoided through planning process development.

The team discovered that 40% of laboratory experiments didn’t lead to improved process understanding. Müllner believes this is likely to be 20% for many client projects, and avoiding those experiments upfront could lead to cost savings.

Bespark*bio says it offers services to aid a wide variety of biotherapeutics, including biologics and bio-nanoparticles.

(Source: Genengnews)