Lipid Nanoparticle Contract Services
LNP Formulation, Manufacturing, and Fill & Finish Services
Our Lipid Nanoparticle (LNP) CDMO service supports pioneers in bringing their diverse API payloads such as nucleic acids (e.g., mRNA, siRNA, DNA), peptides/proteins or small molecules to patients. With over 30 years of experience supporting projects from pre-clinical to clinical and commercial GMP production, we are your trusted CDMO partner.
Our Track Record
1000+
Structures evaluated across diverse libraries to select the best ionizable lipids
30+
Successful screening projects across diverse applications executed by our Early Formulation Screening Service team
30+
Years of GMP manufacturing experience at our Indianapolis site
35+
LNP and Liposomal Programs supported by our Indianapolis team since 2015
7
Commercial drug products manufactured at our Indianapolis Center of Excellence
Our Preclinical Offering
LNPs are essential to ensure safe and efficient nucleic acid delivery to cells. These particles, typically composed of four different lipids, provide a protective bubble for the delicate nucleic acid molecules. As part of our LNP CDMO services capabilities, the Early Formulation Screening Service encompasses a best-in-class expert team that is dedicated to screening and optimizing LNP formulations for your nucleic acid payloads.
Screening of ionizable lipids and of appropriate lipid compositions that provide effective results, functionalization of LNPs with targeting ligands, scale up of lead candidates, 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 essential excipients driving the success of LNP delivery systems. Our carefully curated portfolio of ionizable lipids from multiple independent libraries encompasses a diverse chemical design space, demonstrating a proven track record of success across various applications. We identify the most promising lead lipids for your payloads, complemented by comprehensive analytical characterization including advanced in vitro testing.
Formulation Optimization
We refine the formulation composition and perfect the lead mixture for maximal/optimal efficacy and in vivo tropism. Our advanced analytical characterization includes extensive in vitro and in vivo studies, as well as lipidomics analysis, enabling accurate predictions of biological behavior.
Preclinical Scale-Up
To prepare your formulation for clinical development, we focus on finding optimal manufacturing conditions and transition bench-scale unit operations to their scalable counterparts. Additionally, we offer long-term stability studies and lyophilization development. When the formulation is ready to progress to the clinical phase, our experts ensure a seamless technology transfer to our in-house GMP manufacturing site.
As an experienced CDMO partner, you can rely on us to facilitate seamless technology transfers, robust process optimization, and scalable manufacturing to bridge the gap from discovery to clinical application. Our Indianapolis Center of Excellence has a worldwide reputation in contract manufacturing and fill and finish services for emerging biotech through established pharmaceutical companies. The site has manufactured a wide range of sterile, complex drug products including LNPs, liposomes and PEGylated formulations.
- Demonstrated experience working with diverse API payloads and formulations– LNPs including tLNPs, Liposomal Complexes, PEGylated Enzymes, Suspensions, Small Molecules, Oligonucleotides (mRNA, siRNA, saRNA, pDNA), and Proteins.
- Advanced analytical testing equipment and expertise.
- A smooth transition from preclinical development to process optimization and scale-up for clinical and commercial cGMP manufacturing.
- State-of-the-art VarioSys Filling Line supporting both liquid or lyophilized drug products and Finish services including inspection, packaging, quality control testing, and quality assurance oversite.
Related Documents
- Flyer: GMP Manufacturing of LNP Formulations
From clinical supply to commercial manufacturing, our Indianapolis, Indiana site (formerly Exelead) has a worldwide reputation for handling commercial contract manufacturing and filling for small to large pharma clients.
- Flyer: Early-Stage Development of LNP Formulations
Developing and bringing your formulation to the clinical phase. Our Indianapolis, Indiana site (formerly Exelead) specializes in parenteral, lipid-based drug delivery solutions, with a strong preclinical development process and a proven track record in lipid nanoparticle formulation.
- Flyer: Early Formulation Screening Service
Bringing your nucleic acid modalities into the optimal lipid nanoparticle formulation. As part of our Lipids and LNP CDMO capabilities, the Early Formulation Screening Service, located at our headquarters in Darmstadt, Germany, encompasses a best-inclass expert team that is dedicated to screening and optimizing lipid nanoparticle (LNP) formulations for your nucleic acid payloads.
Related Webinars
This webinar gives insight into our capabilities for customized LNP formulation development for novel therapeutic modalities.
In this webinar, you will learn the process development steps to bring a LNP formulation to GMP manufacturing and clinical trials.
Recommended Readings
- Analytical Techniques for the Characterization of Nanoparticles for mRNA Delivery
This review summarizes the present knowledge on CQAs based on the regulatory guidelines and provides insights into the available analytical characterization techniques for RNA-loaded nanoparticles.
- Rational Design of Unsaturated, Thioether Ionizable Lipids for Enhanced In Vivo mRNA Delivery
This study describes how the rational optimization of ionizable lipids for mRNA-lipid nanoparticles through systematic modification of lipid tail and headgroup structures can improve in vivo mRNA delivery.
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