Lipid Nanoparticle CDMO

Our Lipid nanoparticle CDMO service supports pioneers in bringing their API (mRNA, siRNA, cas9RNA, etc.) to patients. From preclinical to clinical and commercial manufacturing, we use 20 years of manufacturing experience to make your project successful.

• Our preclinical offering
• Our clinical to commercial manufacturing offering

Our preclinical offering

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.

Formulation Screening

Ionizable lipids are considered as key excipients driving the success of LNP delivery systems. Our state-of-the-art portfolio has a proven track record of success in different applications. We identify the most promising lead lipids for your nucleic acid payloads and offer thorough analytical characterization including in vitro testing.

Formulation Optimization

We refine the formulation composition and perfect the lead mixture for maximal/optimal efficacy. We provide advanced analytical characterization, including extended in vitro studies to allow prediction of biological behavior.

Preclinical Scale-Up

To support GLP toxicology and stability studies, we focus on finding the best manufacturing conditions for your formulation and transition bench-scale unit operations to their scalable counterparts. We provide you with results from long-term stability studies. When the optimized formulation is ready to advance towards the clinical phase, our experts ensure the technology transfer to our in-house GMP manufacturing site.

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

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Related Resources

• Webinar: Key quality attributes for mRNA drug substance performance - considerations and best practices 
• Webinar: Custom LNP formulation development - The new Early Formulation Screening Service as a key partner for success
  
• Webinar: How to bring your LNP formulation to clinical/commercial manufacturing via CTDMO services
  
• Flyer: GMP Manufacturing of LNP formulations
• Flyer: Early-Stage Development of LNP Formulations
• Flyer: Early Formulation Screening Service