Rapid, Reliable Response to Biologic Drug Substance and Drug-Product Supply Challenges

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Scott Battist and Willfredo Mateo

Scott Battist, vice president, general manager, and site head for the drug substance plant, Emergent Bio

BJ Hull, vice president, general manager, and site head for the drug product plant, Emergent Bio

Willfredo Mateo, director of MS&T for the Camden fill–finish plant, Emergent Bio

Emergent Bio started by producing treatments for an anthrax emergency. Traditionally, this has been a biodefense company with contracts from the US government. The company is focused on providing specialty products for civilians and military members that address accidental, intentional, and naturally emerging public health threats. It also works as a contract manufacturing organization (CMO) with sites in 10 global locations, has six manufacturing locations including in Canada, and employs more than 1,100 people. Emergent Bio has manufactured vaccines against anthrax and smallpox, and botulism antitoxin as well as treatments for exposure to nerve and chemical agents. Currently, it is partnered with the US government for surge pandemic flu readiness at the Center for Innovation in Advanced Development and Manufacturing and already is working on task orders for Ebola monoclonal antibodies (MAbs), a Zika vaccine candidate, and a Marburg vaccine candidate. Flexible manufacturing is used to address these biological threats and emerging infectious diseases.

Mateo described how efficiently and quickly the company can bring products into clinical testing and produce commercially for customers. He said that the key step is the technology transfer process, of which key elements are appropriate structure (including organizational, site capabilities of both sending and receiving facilities, quality systems with good documentation, and an operational excellence program); the right people (technical transfer team, project managers, and supporting personnel); clear and standard methodology; ongoing communication among client, provider, and production sites; and a strong regulatory compliance record that includes tracking, internal audits, and relationships with regulatory agencies.

He gave examples of Emergent Bio’s efficient and rapid work. In the first case, a client needed a biologic drug product filled quickly. Both the client and Emergent Bio were using the same platform, and Emergent Bio filled the product request in 30 days. Using platforms helps to expedite the supply chain. In the second example, a preformulated bulk product came in needing no method transfers. Using its platform and aligning with the client, The company accomplished the first clinical fill in 60 days. In the final example, Emergent Bio completed a formulation method qualification and a new component qualification in 90 days following signing of a contract. These examples illustrate how using the right platform, having the appropriate structure and the right people, and having a strong regulatory compliance record enables success.

Battist then discussed the drug product side of the business. He described the company’s flexible manufacturing areas, which consist of a ballroom and multiproduct suites that contain single-use bioreactors (SUBs) from 50 L to 2,000 L and double air locks for containment. Decontamination is performed between projects. The facility can work on different products, from microbial products to cell culture to viral vaccines. Emergent Bio also will be building an area for large-scale commercial manufacturing.

During the Ebola outbreak in 2014, Emergent Bio collaborated with GlaxoSmithKline (GSK) to complete the proof-of-concept manufacturing of a modified vaccinia ankara (MVA) Ebola vaccine candidate for use in a phase 1 clinical study using a single GMP run at 200-L scale.

Battist’s final advice was to remember key elements for a successful transfer to keep communicating and to create a strong partnership with your CMO to ensure business continuity and a continuous improvement process.

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