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Posted on: November 2, 2021

NBAF’s Biologics Development Module to Connect Animal Disease Researchers and Industry

NBAF Water Feature Evening (July 2021)

The USDA National Bio and Agro-Defense Facility (NBAF) being constructed in Manhattan will be dedicated to studying foreign, emerging and zoonotic diseases in livestock. This new facility will continue and expand on USDA’s research currently being conducted at the Plum Island Animal Disease Center in New York with the goal of preventing global disease outbreaks.

To support this mission, NBAF will have many “firsts” in its class — the first U.S. biosafety level 4 lab (BSL-4) with the ability to house large livestock and a new, proof-of-concept facility for veterinary medical countermeasures called the Biologics Development Module (BDM). The BDM will help determine whether discoveries being made at NBAF for the detection and prevention of diseases have the potential to become economically viable products. Then, the BDM will help translate NBAF research findings for use by outside partners ranging from government agencies to academia to private industry.

“I see the BDM as a bridge from discovery to manufacturing,” said Steve Witte, BDM director. “My long-term vision is to establish it as a center for excellence for the development of veterinary countermeasures for foreign animal diseases, attracting partnerships not only from academia and industry in the United States, but from the world at large.”

Developing this novel mechanism for collaboration will help take the fight against foreign animal diseases —those from other countries — and zoonotic diseases to the shores where outbreaks exist and prevent potential exposure domestically.

“The best place to fight foreign animal diseases is in the countries where they are endemic, to provide tools to manage these outbreaks to keep them from spreading internationally,” Witte said.

Prevention and preparedness start with the ability to roll out solutions found in the lab at scale in the real world. Typically, researchers produce biologics — diagnostics, vaccines and antibody therapies — at bench scale, meaning a few dozen at a time. The processes for bench-scale production are very different from those needed for large-scale manufacturing and distribution.

“The BDM scientists will translate bench scale to manufacturing production. That’s how we’ll demonstrate that products coming from NBAF scientists and out of the BDM are commercially viable,” Witte explained. “A bench-scale product may not translate into an actual project that will work in the real world. That’s where the BDM will bridge the gap. Through a de-risking process, we’ll give partners the confidence that if they work with us, there’s a better chance they’ll have a commercially viable product on the other side.”

Developing diagnostics, vaccines and antibody therapies can take years, often requiring iterations of formulating, testing, reformulating and re-testing. By working with the BDM, partner agencies will have a trusted ally in getting an NBAF product to market and minimizing risk.

“One of the great things about the BDM is we’ll be doing a lot of this work, so the partners won’t have to,” Witte said. “Our efforts are to protect us domestically, but that means partnering with countries where these diseases are endemic. We’ll go wherever we need to in terms of the science. We’ll have one more weapon in our arsenal against foreign animal diseases.”

Research at the Plum Island Animal Disease Center is currently focused on a handful of diseases like African swine fever, foot-and-mouth disease and classical swine fever, but that list is expected to grow. And the stakes are high for both diagnostic and prevention measures.

“African swine fever has reemerged in the last decade outside of Africa and it’s doing severe damage,” Witte said, explaining Chinese swine herds have been reduced by half due to the disease. “Within the last three months, there also have been outbreaks in the Dominican Republic and Haiti. That’s right in our backyard. Diagnosticians from Plum Island have mobilized to go to the Dominican Republic and Haiti to assist with diagnostic efforts and researchers from Plum Island have a successful candidate for a vaccine so we can be prepared.”

That vaccine candidate and diagnostic efforts are successful but getting solutions to the marketplace quickly is paramount. That’s part of the reason the BDM is focusing on biologics, which originate from natural sources, over pharmaceuticals. 

“When dealing with pharmaceuticals, that is a much slower approach. It requires a larger team, a larger footprint and more equipment. Biologics are faster and cheaper to produce, so the outlay of resources is less for a biologic versus a pharmaceutical product,” Witte said. 

Witte sees great potential for the new unit and looks forward to leading the charge as the BDM continues toward stand-up in the coming months. As NBAF construction nears completion, projected for spring 2022, Witte will finalize operating procedures for the BDM, including how potential partners can engage. 

Parameters for partnerships will vary — each will be evaluated against certain criteria, depending on the type of entity and the needs of NBAF projects, to make sure it’s a good fit. The best way for government agencies, academics and industrial professionals interested in partnering with the BDM to engage is to follow NBAF on its website, Twitter or LinkedIn, where updates will be shared. 

As Witte settles into his role professionally, he’s enjoying life in the Greater Manhattan region personally. He looks forward to welcoming more scientists from Plum Island and around the world to the region.

“I’ve been very impressed by the warm welcome I received here. Manhattan is a great town to live in and there really seems to be a lot of excitement around NBAF in general,” he said.

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