A developer of pluripotent stem cell therapies has trademarked their approach to cost-effective therapy development.

Alder Therapeutics, which is developing two therapies based on donor cells, says the company’s AlderEdge™ approach can help widen the access of patients to therapies.

“One of the key issues in cell therapy is that it’s quite expensive to manufacture the therapeutic products and, at Alder, we want to make [them] available to everyone by simplifying the process and making it cheaper,” explains Kristian Tryggvason, PhD, co-founder and CEO at Alder.

Another co-founder and the company’s former CTO, Ricardo Baptista, PhD, spoke about simple and scalable manufacturing at the Terrapinn conference on Advanced Therapies earlier this year. According to Tryggvason, the key to Alder’s approach is that his father, a professor working on the company’s technology, had a commercial vision from early in development.

“The two key scientists we were working with had read regulatory documents and knew what to avoid when developing their processes,” he explains.

As a result, the fledgling company, which was officially founded in 2022, had a strong basis for further process development.

“Our process was good from the start and we’re making it better,” notes Tryggvason, explaining that sometimes startups can get bogged down fixing processes later in development.

Calculated potential market size

The company also benefited from calculating the size of the potential market for their therapies, along with how fast they can achieve market penetration. According to Tryggvason, this has helped with attracting potential investors, who understand not only the costs of investing, but also the likely returns.

“We’re de-risking for investors who know the market opportunity on the manufacturing side because we’ve thought about the final product that will be given to the patient,” says Stijn Heessen, PhD, co-founder and COO at the company.

While the cells were still being cultured in a cell culture dish, the company calculated how to scale up using existing equipment to a desirable commercial manufacturing scale, including estimating the costs of reagents and personnel. “We had the commercial product in sight right from the beginning,” states Tryggvason.

The company is now tweaking their process to make it more robust and reliable, by identifying weak spots. This includes adopting strategic approaches to product design, such as Quality by Design (QBD), as well as closing the manufacturing process to reduce and remove the risk of human error.

“We want to take [many] small steps to de-risk and optimize the process, including eventually taking out [human] operators to ensure the exact same thing is done every time in the same way,” continues Tryggvason.

Heessen explains that the AlderEdge approach avoids being “penny-wise, pound-foolish” where companies try to save money by rushing into Phase I without adequate planning, leading to them needing to “twist and tweak” later on at great cost to reach a final commercial product.

“We’re spending a little [upfront] on getting CMC and manufacturing properly established [rather than rushing into first-in-human trials],” he says.

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