In 2023, one of Mowery’s first actions as KBI Biopharma’s chief executive officer (CEO) was to incorporate cell-line development services company Selexis, a fellow acquisition of parent company JSR. “The motivation behind the operational consolidation of Selexis into KBI was to streamline the offering for our customers,” Mowery said. The legacy Selexis talent thus enabled the operation of KBI cell-line development in Europe.

Along with the acquisition of Selexis came that company’s SUREtechnology platform. That technology enables KBI to streamline production from clone selection all the way through GMP manufacturing. Mowery said that the technology produces robust cell banks with improved purity compared with other platforms. It also enables customers to move quickly. “We’ve seen some instances,” Mowery said, “where we’re able to do a technology transfer and get some of our customers into GMP manufacturing within nine months.”

Beyond its clone selection technology and cell-line development offerings, KBI offers mammalian, microbial, and analytical services. Aside from the Selexis facility in Switzerland, KBI has five facilities in the United States, three of which are in Durham, NC. Its Venture Center global headquarters houses much of the company’s process and analytical development services. The company’s Hamlin Road facility is progressing into first-in-human manufacturing, and its Patriot Park location specializes in late-stage commercial manufacturing. That site was a finalist for the International Society for Pharmaceutical Engineering (ISPE) Facility of the Year award in 2023. KBI’s microbial facility in Boulder, CO, uses the PUREcoli platform, which Mowery described as “one of the most significant advancements in microbial manufacturing in the last couple of decades.” The Louisville, CO, site serves as a standalone analytical facility that specializes in process characterization.

Mowery explained that KBI’s rich history and technical acumen enable it to stand out in the crowded CDMO space. He said that many of the company’s customers have been clients for over 10 years. The company prides itself on the longevity of its relationships and on helping customers navigate manufacturing challenges and the regulatory landscape. And in January 2024, KBI announced a strategic alliance with Argonaut, which will enhance the customer experience further by enabling the company to provide end-to-end services. Finally, Mowery said that KBI prioritizes helping customers understand the post-COVID challenges relating to capital, so that first-in-human developers can have the best chance to progress through clinical trials and get their therapies to patients.

Watch Online

See full presentations online at https://bioprocessintl.com/category/bpi-theater/bpi-theater-bio-2024.