A contract development and manufacturing organization (CDMO) is taking a people-centered approach to speeding up process development. KBI Biopharma says they’re selecting the best technologies to fill gaps in their processes with grassroots help from their scientific staff.
“We’re keeping an eye on technologies and leveraging our scientific staff to help us with targeted problem-driven solutions,” says Derek Ryan, PhD, senior director of analytical development at KBI Biopharma. “I think our approach of having automation engineers embedded with data scientists and the process scientists doing the work has enabled us to make very key strategic decisions.”
The company claims to have accelerated timelines to first-in-human (FIH) studies by up to 25% due to having multidisciplinary planning meetings where staffers identify pinch points in their processes. Automation engineers can then help identify the best equipment to solve the problem, speeding up decision-making and accelerating process development, Ryan points out.
One example is how upstream process developers had adopted a high-throughput bioreactor due to its analytics, but it generated a lot of samples that needed manipulation to produce quality process insights.
After identifying this bottleneck, the company worked with the manufacturer to source new equipment to screen samples even more quickly, he explains.
“Classically, when we were running the bioreactor studies, it might take two or three weeks to get some analytics to make real-time process decision-making,” explains Ryan. “Now we’re able to get some of those insights in less than a week, or in some cases, real-time, if we’re working up the metabolite data.”
The company is now working with their parent company, JSR Life Sciences, to use artificial intelligence tools and machine learning to speed up data analytics. Ryan spoke about accelerating process development by integrating automation and analytical data digitization at the BioProcess International Conference last week.
