Posted on October 30, 2023 by Aldevron

A Paradigm Shift for mRNA

Throughout our history, Aldevron has committed to advancing every day for our customers by anticipating their needs and innovating products and services to fulfill them. In May, Aldevron announced the next step in that evolution: the expansion of our mRNA capabilities to include lipid nanoparticle (LNP) encapsulation and aseptic fill-finish. Now Aldevron, in partnership with Danaher operating companies Precision Nanosystems (PNI) and Cytiva, can offer mRNA cGMP production from the master cell bank (MCB) all the way to drug product.

To discuss these advancements further, Aldevron’s Vijay Surapaneni, vice president of Global Manufacturing and Supply Chain operations, chats with Todd Howren, vice president of RNA services about the significance of this new offering.

Vijay Surapaneni: What’s most exciting to you about Aldevron’s expansion into LNP encapsulation and fill-finish for mRNA development?

Todd Howren: It really begins with our mission to build a complete RNA ecosystem, which is a full-service, end-to-end offering that takes customers from sequence to finished drug product all under one roof and one quality system. Looking back to when Aldevron was founded, we were primarily a supplier of critical materials. Then in 2018, leveraging our nearly 20 years of biomanufacturing experience, we began manufacturing and supplying GMP mRNA drug substance, and to date, we have successfully manufactured mRNA drug substance supporting both preclinical programs and phase 1, 2 and 3 programs. This year, our vision to provide end-to-end mRNA services (from MCB to mRNA drug product) was realized with the launch of our LNP encapsulation and aseptic fill-finish suites.

VS: These new capabilities will really help our clients streamline their operations, right?

TH: Yes, just think about how customers operated before: They may have worked with one CDMO for the cell bank, a second for linear pDNA, followed by a third for mRNA drug substance, and then potentially a fourth CDMO for encapsulation and fill-finish. This paradigm is untenable. This is not to mention analytical testing. In the past, some of Aldevron’s clients have engaged a third-party analytical testing partner. Today, Aldevron’s full-service mRNA ecosystem now enables Aldevron to conduct and manage all analytical development, testing and release.

Because of this, Aldevron can holistically manage a client’s complete project, from MCB to drug product, under a single program management system and project manager. This enables us to expedite project timelines, ensuring that the client’s program meets all milestone dates and objectives.

VS: Why do you believe this is the right time for Aldevron to be offering end-to-end mRNA solution?

TH: One only has to look at the pipeline for mRNA therapeutics and vaccines. Globally, there are approximately 1,400 mRNA programs in-flight, from discovery to phase 3. I believe we're going to look back, 10 years from now, and say this was a paradigm-shifting time in science and medicine. Today, we are at the precipice of when mRNA therapeutics and vaccines become mainstream. I believe Aldevron can be a key force in shaping this space, and patient care, by better enabling our clients with cutting-edge services and capabilities.

VS: How does being a part of Danaher enhance our end-to-end mRNA offering?

TH: The speed at which we were able to develop, build, validate and launch these new services was only possible because of our partnerships with other Danaher life sciences companies, primarily Cytiva and PNI. Having immediate access to industry leading equipment and instrumentation was important, however, the greatest value was in our ability to leverage the technical, scientific, and operational expertise of our fellow Danaher colleagues. By doing this, not only were we able to move fast, but more importantly, it enabled us to develop and build a high-quality and robust mRNA drug product platform.

VS: The term “paradigm shifting” might sound scary to some, but you seem to have a more positive view. Can you explain further?

TH: To me, paradigm shifting is about setting a new benchmark for your industry. What we have built offers a paradigm shift in how our clients are able to bring new therapeutics and vaccines to the clinic. Further, at Aldevron, we have people who really know RNA sciences, manufacturing, testing, quality control and more. The ability to transform and lead a new market can only happen when you have that type of comprehensive expertise. I believe Aldevron is indeed leading and advancing the mRNA space. I am excited about what this means for the future of healthcare!