Lipid Nanoparticle CDMO

As part of our globally integrated mRNA-LNP CDMO capabilities, the Early Formulation Screening Service encompasses a best-in-class expert team that is dedicated to screening and optimizing lipid nanoparticle (LNP) formulations for your nucleic acid payloads.

LNPs are essential to ensure safe and efficient delivery of nucleic acids to cells. These particles, typically composed of four different lipids, provide a protective bubble for the delicate RNA molecules. The lipid type, the identification of the appropriate composition that provides effective results, the optimal manufacturing process of LNPs, the development of advanced characterization techniques, or long-term stabilization, are only a few examples of technical challenges that we, as experts in the field, tackle for you.

Our clinical to commercial manufacturing offering

We have strategically placed ourselves as a specialized pharmaceutical company, providing end-to-end service for pioneers that operate in this market. Our Indianapolis, Indiana site has a worldwide reputation in contract manufacturing and filling for small to large pharma clients. We not only support clients in the pre-clinical phase but also with manufacturing and fulfillment during the clinical trial process. We manufacture a wide range of sterile products, with a specialization in complex biological products, specifically lipid nanoparticle, liposomal, and PEGylated formulations. In addition, we can customize a pharmaceutical manufacturing process to your exact specifications, offering aseptic product manufacturing in a closed system as well as end-point sterile filtration.

• Long experience with versatile API and formulations: Lipid Nanoparticles (LNPs), Liposomal Complexes, PEGylated Molecules, Suspensions, Small Molecules, Oligonucleotides (mRNA, siRNA, RNAi, saRNA, DNA, Duplexes), Proteins, Aseptic Preparations, Proteins
• Advanced analytical testing equipment and expertise.
• A smooth transition from preclinical development to process scale up, clinical batch and cGMP manufacturing.
• Multiple manufacturing lines and Fill & Finish capabilities (closed RABS system and isolator system)
• Full support services including packaging and inspection, quality control, supply chain and distribution