When Less Is More

January 31, 2024 by Nate Spangler, Ph.D.

Seeking fewer partners with more capabilities

Part 2 in an ongoing series

Messenger RNA (mRNA) shows promise for the treatment and prevention of many diseases. Compared to established technologies, mRNA-based drugs and vaccines are potentially more effective and scalable. However, mRNA manufacturing is not without complexity; it involves specialized production steps such as the DNA template, mRNA drug substance, lipid-nanoparticle (LNP) encapsulated mRNA drug product, fill-finish, and analytical testing.

To manage this complexity, developers of mRNA-based drugs and vaccines often partner with contract development and manufacturing organizations (CDMOs). This outsourcing can be an effective strategy to forgo the considerable time and cost needed to build and operate a factory, which frees capital and other critical resources to focus on pipeline R&D and early milestones.

Because of the diversity of specialized capabilities and experience needed to manufacture mRNA for clinical and commercial uses, the process typically requires the involvement of multiple, specialized CDMOs and contract testing labs in the supply chain.

In such an arrangement, developers have the flexibility to choose the most suitable outsourcing partner for each step of production. However, using multiple outsource partners adds more complexity to an already complex process, leading to the following disadvantages:

Poor Communication and Coordination
The more outsourcing partnerships in the supply chain, the more difficult it is to coordinate and communicate effectively. This increases the chances of mistakes that will have a ripple effect, jeopardizing program milestones and timelines.

Logistical Complications
CDMO activities are interdependent with each other, and as materials progress from one outsourcing partner to the next, time is lost in each handoff. In GMP manufacturing, materials typically cannot transfer between CDMOs without full QA review and release, and the lag time will increase if a slot is not available when material arrives at a receiving CDMO.

Moreover, any unexpected delay at one CDMO will disrupt the entire production supply chain, and rescheduling downstream activities at the other CDMOs may be difficult and costly, if not impossible.

Inconsistent Quality Control, Difficult Regulatory Compliance
Systems, practices, and experience vary from one CDMO to the next. Relying on multiple outsourcing partnerships will increase the difficulty of ensuring consistent quality outcomes and regulatory compliance for the production and distribution of your mRNA-based product.

Intellectual Property Concerns
Sharing proprietary information and production processes among multiple outsourcing partners increases the risk of intellectual property theft or infringement.

The Takeaway
CDMOs provide ready access to specialized capabilities and experience that can help the developers of mRNA medicines reduce capital outlays and reach clinical and commercial milestones faster. In this way, outsourcing is a smart strategy, which can be maximized by finding a single supplier that can provide all the needed services so you can simplify your supply chain.

In upcoming posts, we’ll expand on the theme of using a single CDMO, further exploring the advantages of this approach and what you should look for to find the right outsourcing partner for development and manufacturing needs, from the DNA template to the mRNA-LNP drug product.

• Read Part 1 of this series, Streamlining mRNA Production
• Learn more about Aldevron’s mRNA platform and services
• Have questions on this topic? Contact Nate Spangler
• Visit the Alliance for mRNA Medicines (AMM) website
• Have an idea for a topic? Let us know!

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