Innovative Nucleic Acid Therapeutic Formulation
Leverage our team’s support to empower your project with expertise across a wide range of nucleic acid modalities, state-of-the-art facilities, and a successful history working through novel challenges. We are experienced in the formulation of nucleic acid-based therapeutics as high concentration liquids, lipid nanoparticles (LNPs), novel nanoparticles, and packaged within virus-like particles (VLPs). Our expertise in analytical characterization of nucleic acid drug substances as well as drug products allows us to optimize your formulation for the intended route of delivery, storage conditions, and stability.
Supported Therapeutic Classes
Formulating nucleic acid therapeutics often presents unique challenges regarding aggregation, precipitation, and drug-excipient interactions. Considering these obstacles to effective delivery paired with the diversity and novelty of this drug category, partnering with our team offers innovative approaches to advancing your formulation. Additionally, we aim to establish a final drug product formulation which satisfies key quality criteria for impurities, potency, and stability.
Most oligonucleotides are formulated as high-concentration liquids to minimize the addition of excipients. We evaluate the viscosity, osmolality, turbidity, and buffer capacity of liquid oligonucleotide formulations to ensure they are suitable for handling during administration. Our analytical expertise gives you confidence in the stability assessment of candidate formulations. In turn, you can advance your program with a drug product that exhibits the optimal potential of safe and effective delivery.
Lipid Nanoparticles (LNPs)
Formulation of RNA therapeutics into LNPs is the most common delivery technology to protect the RNA from nucleases found in biological tissues. However, the RNA polymer is still fragile, resulting in the need to store the LNP containing the RNA as a frozen liquid or lyophilized solid. Careful selection of excipients is needed since the stresses of freeze/thaw cycles or lyophilization frequently damage the nanoparticle. We have experience in developing lipid formulations that achieve efficient encapsulation of the RNA as well as the selection of excipients needed to maintain the particle size during storage.
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.