A Focused Approach

March 13, 2024 by Nate Spangler

Aiming to Simplify Biological Drug Production

Part 3 in an ongoing series on mRNA Production

Previously, I highlighted the benefits of outsourcing and its drawbacks when multiple CDMOs become interdependent links in the supply chain. Producing mRNA-based medicines involves several specialized manufacturing steps, and developers often choose to contract these out to multiple CDMOs, each having specific capabilities.

While this approach can increase outsourcing flexibility and offer wider access to specialized expertise, it also comes with a greater risk of costly problems and delays due to the complexity of communication and coordination. In this post, I'll explore how to minimize the downside of outsourcing by working with an end-to-end contract manufacturer.

What is an end-to-end contract manufacturer?
An end-to-end contract manufacturer offers all services required for a production program. However, there also should be a focus on having comprehensive, advanced services in a sequence-to-vial production process. In the case of mRNA-based drugs and vaccines, a technology leader in this area would offer:

• DNA template
• Master cell generation
• mRNA drug substance
• LNP-encapsulated mRNA drug product
• Fill-finish
• Analytical testing

This approach simplifies outsourcing by consolidating the entire production process into a single facility, eliminating the need to coordinate and communicate among multiple parties. Beyond that, the benefits are:

• Streamlined communication and coordination
  Working with an end-to-end contract manufacturer eliminates the need to coordinate and communicate among multiple parties, reducing the potential for miscommunications and delays.
• Consistent quality control
  With a single contract manufacturer responsible for the entire production process, there is a greater ability to ensure consistent quality control standards and procedures are followed throughout.
• Simplified supply chain management
  Consolidating production into a single contract manufacturer can simplify the supply chain, reducing the risks associated with relying on multiple suppliers.
• Cost savings
  Cost savings can be made due to economies of scale, simplified workflows, and reduced costs associated with managing multiple suppliers.
• Enhanced regulatory compliance
  Having one contract manufacturer responsible for the entire production process, it is easier to ensure compliance with regulatory requirements for drug production and distribution.
• Faster production timelines
  By removing additional steps and bottlenecks associated with materials transfers between CDMOs, manufacturing timelines can be shortened. Moreover, a single contract manufacturer likely has more control over its production schedule, so it can better manage and adjust resources to meet production timelines.

The Takeaway

By consolidating drug production into a single contract manufacturer, companies can reduce the potential for errors and delays, resulting in faster time to market and reduced overall risk. A contract manufacturer with advanced technology can:

• Offer benefits such as streamlined communication and coordination
• Consistent quality control
• Simplified supply chain management
• Cost savings
• Enhanced regulatory compliance
• Faster production timelines

Working with a contract manufacturer using advanced technologies in an end-to-end process is worth considering for companies looking to optimize the production process, while reducing potential risks in biological drug production. And as we continue in our series, we’ll discuss the critical capabilities and technology to seek when considering a single CDMO as a manufacturing partner.

• Learn more about Aldevron’s mRNA platform and services
• Have questions on this topic? Contact Nate Spangler
• Have an idea for a topic? Let us know!

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