Streamlining the Drug Development Process

May 3, 2023 / by Yasser Kehail

Aldevron expands mRNA production capability

After years of service providers becoming more specialized, we’re now seeing a reversal in that trend. Enterprise offerings and solutions are on the rise, from consumer offerings to huge corporate deals. We can attribute this growth to an increased demand for simplicity of transactions, clear accountability, and building a win-win situation for both parties.

However, for a biotechnology company developing novel therapeutics against a specific disease, there can be literally dozens of partners, contractors and collaborators needed throughout the program’s life cycle. This adds substantial complexity and risk to a development. There are a number of considerations for coordinating such a large project, coupled with the potential for timeline delays, which can create a very stressful working environment.

If we zoom in the clinical supply (CMC) landscape, a company can be managing, auditing and/or negotiating with a half-dozen partners at a given time, to procure critical raw material, produce drug substance, formulate drug product, then send to a fill/finish site. For a small to mid-size biotech, time is of the essence. If there is a failure on the part of any of the partners, or any items are out of specification (OOS), the client’s entire program could be in jeopardy.

Bringing drug product into the mix
As a critical raw material supplier for decades, producing plasmid and mRNA drug substance (DS), Aldevron has continually expanded its capabilities to support our clients. Backed by our quality track record, state-of-the-art facilities, and dedicated associates, it is a natural progression to start supporting clients with drug product (DP).

We are now prepared to support preclinical and early-stage clinical programs that need grams of mRNA DP dispensed in thousands of vials. We’ll expand into commercial programs as client programs progress in the coming years. From a technology perspective, we are vertically integrating LNP encapsulation technology from Precision Nanosystems (PNI), a fellow member of the Danaher family of companies.

PNI has decades of experience in lipid formulation and technology platforms. We will also be leveraging the expertise of another Danaher company, Cytiva, using its new robotic fill machine (SA25), and its market leading Akta platform for purification and filtration.

If you’d like to learn more about our mRNA expansion and how it can benefit you, view the news release announcing our newest service.

• Visit our RNA - Custom Manufacturing web page
• Watch our webinar, Comprehensive GMP Manufacturing of mRNA-LNP Drug Products
• Want to learn more? Contact Yasser Kehail with your questions
• Read Yasser’s post on encapsulation and mRNA
• Read Todd Howren’s post on Capability versus Capacity