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. Each of these is formulated into an 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 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 & Technology Transfer team to ensure consistent product quality across all manufacturing scales.

Nucleic acid-LNP are exceptionally complex therapeutics and their characterization and the confirmation that they meet our quality expectations is the responsibility of our Analytical team. Using leading-edge analytical techniques and equipment, they evaluate a wide range of product attributes to ensure that Acuitas LNP formulations meet stringent quality, efficacy and safety requirements. Supporting both internal and partner programs, the team conducts R&D 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 regulatory filings. In addition, our Preclinical team provides advice and support to partners during the transition from preclinical to clinical development.

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 manufacturing. Our Process Development team is responsible for the development of 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, this 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 (CMO).

Acuitas’ business model and partnership approach ensures that our partners’ goals and objectives are directly aligned with ours. We build a foundation of collaborative, productive relationships with our partners to meet their objectives and to bring new therapeutics to patients as quickly and safely as possible.

The Business Development team supports new partnerships, working with a variety of organizations, from emerging biotech firms and pharmaceutical companies to academic institutions and NGOs. This team is focused on understanding our partners’ drug development goals and needs and establishing a relationship that enables success.

The Strategic Alliance Management (SAM) team is responsible for onboarding new partners and ensuring a successful collaboration. They facilitate joint planning, information flow, problem-solving and regular inter-team meetings to coordinate activities and monitor progress. They direct technical questions to the appropriate Acuitas team member(s) and ensure timely feedback.

The Corporate, Operations and Legal teams support the innovative science at Acuitas through crucial departments like Finance, Information Technology, Legal & IP, Facilities Management, People & Culture, Events, Communications, and Strategic Planning.

Our Legal Team plays a key role in the strategy and governance of the organization, as well as managing our extensive IP portfolio to support Acuitas in meeting its strategic and operational goals.