Limiting Risk In mRNA Development and Production

Limiting Risk In mRNA Development and Production

November 22, 2021PAO-11-21-CL-05

Doug Kennedy, Arranta Bio’s Vice President of Site Operations at the Watertown, Massachusetts facility, explains how mRNA is manufactured, the technology required to implement these processes, and how the company is reducing risk and keeping employees safe throughout its operations.

David Alvaro (DA): Can you tell me about the team that has been assembled here at the Watertown facility?

Doug Kennedy (DK): We have approximately 130 employees. Of those, about 40 employees represent the manufacturing department. The quality assurance, quality control, and analytical development groups comprise of about 20% of the organization, collectively. We have approximately 12 employees in the process development organization, and the balance of our staff serves in roles in facilities engineering, supply chain, or administrative support.

DA: What are the typical steps in manufacturing mRNA?

DK: There are three primary steps in manufacturing mRNA. One is synthesis, followed by purification, and the last is the formulation of a drug product. Each operation, including support of enzymatic operations, purification processes, and tangential flow filtration, is a key element of the overall process. The platform that Arranta Bio has established leverages a single-use lipid nanoparticle (LNP) mixing station that allows different mixing technologies to support our core customer requirements. These operations can be introduced at various stages to meet mRNA manufacturing demands. We’re fortunate at our Watertown facility to be able to execute all three stages in one location, putting us in a great position to be successful.

DA: What types of technology are you able to implement at each of those critical steps?

DK: Arranta Bio has developed a flexible manufacturing platform that allows equipment to be integrated with enzymatic reactions, purification processes, and tangential flow filtration. The modality and mobility of our equipment allows us to stage our unit operations in order to meet the challenges presented by our customer’s mRNA manufacturing processes.

DA: What are some of the more complex or high-risk processing steps that need to be considered particularly carefully?

DK: The production of the LNP processes is the highest risk from a safety perspective. To limit this risk, we’ve invested heavily in engineering controls in the facility, not limited to the life safety systems, HVAC systems, and electrical configurations in efforts to keep our employees safe.

DA: How would you characterize the expertise that Arranta Bio is able to bring to these complex manufacturing process steps?

DK: Arranta Bio’s technical leaders have set up many mRNA processes throughout the industry. Our Head of Process Engineering is a subject matter expert not only in developing the process, but also in using the technology around any equipment. Members of our manufacturing team previously worked in mRNA manufacturing, working on COVID-19 vaccine programs in Massachusetts.

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