Solutions for Rapid Development and Manufacturing Responses to COVID-19 and Other Public Health Threats

Richard W. Welch, PhD, vice president of development services, Emergent BioSolutions

Welch focused on elements of pandemic preparedness. Emergent has a history of working with the US government on bioterrorism and biodefense preparedness, with a focus in recent years on developing platform-based responses to emerging disease threats. Emergent is focusing on therapeutics and vaccines to respond to COVID-19.

The company’s therapeutic business unit uses the company’s internal hyperimmune process to generate therapeutics from the plasma of recovering donors, leveraging an already validated good manufacturing practice (GMP) platform for rapid scale-up and manufacturing. Multiple vaccine platforms include those that use nanoparticles, recombinant viruses, and nucleic acids. Not every platform will be suitable for arising pandemics, and the ability to make small corrections required in development for transferring scale-up and manufacturing is critical for using vaccine platforms for a rapid response. Welch is part of Emergent’s expanding contract development and manufacturing organization (CDMO). Supporting a broad number of platform processes allows the company to customize a customer’s pathway, linking that to an existing service offering and supporting drug-product development from early phase clinical production through launch, commercialization, and final delivery.

Welch described a partnership begun with the US government’s Biomedical Advanced Research and Development Authority (BARDA) in 2011 to become one of the Centers for Innovation in Advanced Development and Manufacturing (CIADM). That work enabled Emergent to expand its capabilities for supporting commercial responses to pandemics by leveraging the CIADM, Emergent’s flexible manufacturing facility, and both commercial and government partnerships. The CDMO business unit supports clients from early development stages through process characterization, supporting GMP drug-substance and drug-product manufacturing and providing both viral and nonviral final fill–finish and packaging. The company makes more than 40 commercial products and has contributed to development of more than 200 clinical projects, with experience with a number of public-health authority inspections (EMA, FDA, and other agencies).

Clinical and commercial processes include nanoparticle and recombinant viral platforms for upstream cell-culture processing and downstream formulation development and support. Flexible transfer to manufacturing facilities is critical to supporting commercial-scale manufacturing. Emergent’s flexible drug-substance manufacturing facility near the Bayview campus in Baltimore, MD, is a single-use facility that moves product from seed trains into production bioreactors, then into harvest and purification. Without being bound by fixed equipment, the company can be flexible in moving facility components around to personalize approaches to a customer’s novel platform.

The drug-product facility offers viral and nonviral capabilities. The nonviral facility in Baltimore has one syringe and two vial filling lines. The viral fill facility in Rockville, MD, is equipped for one clinical and one commercial vial-filling operation using isolators up to biosafety level 2 (BSL-2), with batch sizes up to 12,000 vials. Both facilities are expanding to in response to the COVID-19 crisis.

Welch described some current partnerships. Emergent is working with Novavax to develop both drug substance and drug product for a nanoparticle vaccine, with an agreement to provide clinical supply to support a phase 1 trial. A development program with Vaxart will support a phase 1 clinical trial in the second half of 2020. His third example highlighted an agreement to manufacture drug substance for Johnson & Johnson with the goal of meeting long-term commercial supply needs (currently in negotiation).

He concluded with key takeaways from work toward pandemic preparedness. Establishing partnerships early on will smooth business relationships as that project moves into its critical stages. Leveraging platform processes where appropriate will provide the best chance to meet the COVID-19 threat with multiple vaccines. High-throughput and/or parallel processing, “rolling technology transfer” (working with R&D development and manufacturing at the same time), and manufacturing flexibility enables a CDMO to focus on innovator needs. End-to-end capabilities support everything from early development through final drug product, simplifying both a customer’s supply chain and scale-up to final commercial manufacturing.

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