KBI Biopharma, a JSR Life Sciences company, held a ribbon-cutting at the company’s new state-of-the-art $150 million, 150,000 square-foot commercial manufacturing facility in Research Triangle Park (RTP), NC.

Now fully operational, the site employs more than 200 people in production, supply chain, engineering, quality control and quality assurance positions. That number is expected to grow to 350 by the end of the year, with the site’s intense focus on attracting and hiring high-performing employees. The ribbon-cutting, held on April 20th, was attended by the following:

• Tim Lowery, president, JSR Life Sciences
• Michael Landau, interim chief operating officer, KBI
• Jesse Kingg, senior vice president and site head, Patriot Park, KBI
• Laura Rowley, NC Biotech VP, Life Science Economic Development
• Geoff Durham, Durham Chamber president and CEO

KBI built this facility to support the manufacturing of mammalian-based products, starting with an undisclosed client’s late-phase clinical and commercial programs.

“Our new facility allows KBI to remain on the cutting-edge of the latest innovations in automation and digitalization,” said Kingg. “With the highest quality people, systems, and processes, we intend to be a true center of excellence and an exceptional place to work.”

In line with JSR Life Sciences’ ONEDigital initiative, the new facility will incorporate Manufacturing 4.0 principles through the design and integration of advanced technologies.

Innovations include:

• Digital data collection systems, including electronic batch records, electronic logbooks, paperless materials management, and Laboratory Information Management Systems (LIMS) for quality control data management. These tools will enable real-time process and product quality monitoring and allow for future AI technology adoption.
• The facility has a ring corridor for suite access and a “science on display” viewing to showcase the facility to KBI clients.

KBI will use the facility as an option to provide clients with commercial launch material and market supply. KBI’s proven single-use platform ensures supply reliability with redundant equipment, automation, and full utility backup. Features include:

• Six 2,000-liter, single-use bioreactor systems and associated harvest and purification equipment can initially produce more than 70 batches per year and ramp up to meet additional demand.
• Advanced analytical services for commercial product characterization and release testing capabilities will support commercial launch and routine supply in tandem with the manufacturing operations.

“KBI prides itself on a creative approach to client collaboration,” said Landau. “Our customers turn to us to scale manufacturing processes suitable for commercial supply, and our scientific expertise with complex projects that deviate from standard planning protocol. It’s facilities like this and our strong client relationships that make this possible.”

This is the second major facility expansion announced by KBI within the last two years. KBI previously announced a new 5,600-square-meter biologic bulk drug substance manufacturing facility in Geneva, Switzerland. That facility is scheduled to be operational by mid-2022 and will employ more than 200 people in development, operations, and quality assurance positions.