Drug Product Manufacturing

Formulation

This critical step for drug product manufacturing enables safe and efficient delivery into the cells and lead the way into a new era of genetic medicine. With over 50 cGMP lots generated, we now collaborate with Precision NanoSystem (PNI) expertise to provide critical components for mRNA therapies, further expanding our mRNA manufacturing capabilities by adding scalability of LNP encapsulation from research grade to GMP. Our goal was to form the most comprehensive portfolio of products and services essential for mRNA vaccines and therapeutics development to suit your program.

• Incorporating PNI’s technology and expertise for large scale capacity
• Transfer any formulation from PNI’s lipid library, as an initial step for screening
• Leverage PNI’s NanoAssemblr® GMP System to obtain process consistency and encapsulation efficiency
• We optimize and scale based on customer needs through various stages of development and maintaining your desired specifications

Encapsulation

We are also a full service CDMO covering all phases from pre-clinical development to commercial manufacturing for LNP encapsulation. Our integrated mRNA CDMO platform provides manufacture capabilities for final mRNA drug products to advance your therapeutics. Our support through production, analytics, and regulatory will significantly decrease complexity and enhance speed to commercialization to help advance life-enhancing therapeutics.

Fill/Finish

Aldevron has recently launched a comprehensive drug product platform which is supplemented by Fill/Finish capabilities via the SA25 Aseptic Filling Workcell from Cytiva within our GMP mRNA Suites to provide high-quality and characterized final drug product.

With this closed aseptic filling of mRNA drug products capability, we aim to reduce risk and improve agility. Under the Danaher umbrella, Aldevron is positioned to advance multiple candidates, including mRNA vaccines and therapeutics, all under one manufacturing and quality system to meet the need for final drug product manufacturing.

Analytical

As important as flexible and scalable platform technologies are to the rapid development of mRNA-based therapeutics, they would not be possible without rapid, robust, accurate, sensitive, and scalable analytical technologies. Aldevron is position with partnership with Danaher Operation Companies, that include PNI, Cytiva, and SCIEX, to provide clients the customizable analytical and method assay to validate the process of manufacturing from sequence to vial.