Industry-leading expertise and experience.

The improved potency and safety of our next-generation LNP is largely based on innovative lipid chemistry. Our Chemistry team has designed and synthesized more than 1,000 novel lipid compounds. These are formulated into LNP and the biophysical characteristics and biological properties (potency and safety) of these novel LNP are then determined. This information is used to create and refine a structure-activity relationship (SAR) model that we use to predict additional active lipids as part of a continuous, iterative process. This team also manages the development and external production of cGMP-grade proprietary lipids to support partner clinical programs.

Our Formulation Development team supports our partners and internal research teams, generating thousands of LNP formulations each year. The team ensures that each individual batch exhibits optimal biophysical parameters, while also ensuring efficient loading of the nucleic acid payload. This may require the development of new formulation compositions and processes to accommodate novel payloads, to incorporate novel lipid components, or to enable new clinical applications requiring a different route of administration. The Formulation Development team also works closely with our Process Development and Technology Transfer team to ensure consistent product quality across all manufacturing scales.

Nucleic acid-LNP are exceptionally complex therapeutics and their characterization and quality assessment is the responsibility of our Analytical team. Using leading-edge analytical techniques and equipment, they evaluate a wide range of attributes to ensure that Acuitas LNP formulations meet stringent quality requirements. Supporting both internal and partner programs, the team conducts R&D studies and stability studies, develops novel analytical methods, and assesses new analytical tools and technologies.

Understanding the biological behaviour of our LNP systems is critical to ensuring they can be used safely and effectively to treat patients. Our Preclinical team is responsible for designing and executing the studies needed to fully characterize our LNP carriers in vivo, including extensive safety studies. To ensure that the findings are predictive of clinical outcomes, our primary focus is on non-human primates (NHP) studies. This team has generated an extensive database for our most advanced LNP formulations, and study reports are available to our partners to support their development and regulatory filings.

A key requirement in the development of a new therapeutic is to ensure the consistency of that product from early preclinical evaluation to final commercial manufacture. Our Process Development team is responsible for developing manufacturing processes and equipment that can support the clinical development phase and, subsequently, commercial manufacturing while ensuring that those scaled-up processes replicate methods used during earlier stages of development. In addition, our Process Development team works directly with partners to support the transfer of our manufacturing process to our partners, taking advantage of our global network of contract manufacturing organizations (CMOs).

Our Business Development team supports new partnerships, working with various organizations, from emerging biotech firms and large, international pharmaceutical companies to academic institutions and NGOs. We are focused on understanding our partners’ drug development goals and needs and establishing a relationship that enables success.

Our Strategic Alliance Management team is responsible for onboarding new partners and ongoing relationship management to ensure a successful collaboration. This team facilitates joint planning, information flow, problem-solving and regular inter-team meetings to coordinate activities and monitor progress.