Biological Process Development Facility

With scientific breakthroughs, there is often a "eureka" moment when a researcher first realizes a process or technology can solve a problem. It’s no different with breakthroughs supporting the safety and well-being of warfighters. These are moments that make headlines — big discoveries that tell us a better world or a smarter, stronger, safer soldier is possible.

"We often forget the hard work doesn’t end with 'eureka,'" said Marty Sikes, associate executive director of chemical and biological defense programs at the National Strategic Research Institute (NSRI) at the University of Nebraska. "There is an important space between revolutionary discoveries and fielding innovative and timely solutions. This critical space is one that NSRI and its partners are uniquely positioned to fill."

An essential collaborator in helping NSRI close that gap in biological processes contributing to national security is the Biological Process Development Facility (BPDF) at the University of Nebraska–Lincoln (UNL). In addition to a wide range of other biological development work, the facility develops, tests and documents processes that turn raw, one-time laboratory products into practical, large-scale manufacturable defense-related products.

Staffed by experts with decades of academic and commercial experience, and equipped with cutting-edge technology, the BPDF is perfectly situated to provide the missing link that transforms brilliant ideas into real-world solutions.

"Time and again, the BPDF has served a critical role in our national security work with federal government agencies," Sikes said. "With recent investments from NSRI and UNL, it is going to continue to be a partner in executing and innovating for the Department of War (DOW)."

About the Biological Process Development Facility 

Beginning as a protein research laboratory in the mid-90s, the BPDF has expanded to a broad range of biological research and development projects, specifically tailoring its capabilities to provide much-needed support to researchers, students, defense agencies and commercial manufacturers.

The facility specializes in microbial expression systems — working with the materials microorganisms produce. Using advanced onsite equipment and applications, the BPDF uses genetically engineered organisms such as bacteria and yeast to produce a specific protein, enzyme or other material of interest. This could be the active ingredient in a vaccine or biotherapeutic, or an intermediate to be used for further processing.

Although the BPDF provides support for projects in all stages, one compelling aspect of the facility is its Good Manufacturing Practice (GMP) operation, which ensures developed products can be manufactured for safe human use.

"Anything produced for human use — injectables, oral medications, etc.,  — needs to be produced under GMP,” said Dennis Hensen, BPDF director. “It includes operating under a  quality system and quality assurance program and having standard operating procedures to make sure you’re doing things the right way and ensure the process is documented and reproducible."

The BPDF’s GMP facility is equipped with impressive systems to help facilitate GMP production, including isolated hot and cold water loops for process temperature control, more than 6,000 square feet of clean room space, which includes a purification suite to isolate the target materials.

One unique feature is the BPDF's ability to produce ultra-pure water for injection (WFI) within the building as a medium for injections — a capability that proved useful during the COVID-19 pandemic.

"During COVID, finding and acquiring raw materials to do anything in the lab was very difficult," Hensen said, "but thanks to our WFI system, water for injections and for a processing input was one thing we didn’t have to worry about."

The system takes water collected through reverse osmosis — already very clean — and further purifies it through a process of steam and condensation, creating an ultra-pure water that can be injected into a person’s body without fear of causing additional complications.

The facility features dedicated steam and process gas lines and an uninterruptible power supply and backup generator to ensure critical equipment stays online in the event of an outage.

These assurances are concrete examples of the BPDF’s dedication to quality assurance, which it brings to a wide variety of projects. The BPDF also has access to a broad pool of multidisciplinary university researchers across the University of Nebraska's four campuses.

"We have flexibility that larger contract manufacturing organizations (CMOs) don’t have," Hensen said. "If there’s a change needed during a project, we’re able to pivot on the fly and collaborate to find solutions."