Advanced Nucleic Acid Process Development
Producing satisfactory nucleic acid therapeutics is rapidly evolving, often challenged by molecular stability and technical complexity. Our expert team and state-of-the-art facilities offer specialized support and innovative approaches. We have experience developing novel processes outside the common platform processes used by established contract manufacturing organizations (CMOs) making oligonucleotides by solid phase synthesis or RNA using in vitro transcription.
The foundation of successful process development programs is based on the quality of analytical data. While we support quality by design (QbD) approaches, an understanding of the fundamental chemistry and biochemistry of the process is needed to make rational use of QbD experiments when developing novel processes. This integral background enables our team to identify and mitigate potential quality risks early on.
Supported Molecules
We support the development of processes with chemical modification (e.g., conjugation) to nucleic acids and the synthesis of nucleic acid-based molecules using enzymatic processes. Our team also offers downstream process development including chromatography and tangential flow filtration (TFF).
Given the challenges of delivering nucleic acid-based therapies, developing novel drug products is an active area of research. We have experience with novel delivery approaches for a range of nucleic acids. This experience features molecules such as virus-like particles (VLPs), nanoparticles formed with cationic polymers, and metallic nanoparticles with chemically attached modifications. Additionally, our background includes developing lipid nanoparticles (LNPs) for the delivery of nucleic acid-based drugs.
We have experience developing lyophilized formulations of LNPs containing mRNA to improve the stability and reduce the supply chain challenges of using low-temperature freezers. We can develop lyophilization cycles to meet the needs of your project.
Integrated Laboratory Services
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.