By combining complementary expertise, the collaboration aims to address one of the longstanding challenges in biologic formulation development: the limited availability of excipients suitable for injectable medicines.
As biologic therapies become increasingly complex, formulation scientists face growing challenges in achieving product stability, manufacturability, and long-term performance. While excipients play a critical role in addressing these challenges, relatively few are available for parenteral biologic applications, limiting formulation flexibility.
Through this collaboration, ten23 health contributes its expertise in formulation development for sterile products, analytical characterisation and pharmaceutical manufacturing, while dsm-firmenich brings extensive capabilities in pharmaceutical ingredient science, quality systems and regulatory support. Together, the teams are evaluating pharmaceutical-grade ingredients with established safety profiles as potential excipient candidates for biologic formulations.
The research follows a structured scientific approach, including proof-of-concept studies, benchmarking against established excipients and evaluation in representative protein formulations using advanced analytical methods. Initial findings have identified promising candidates, which are currently undergoing further verification and characterisation.
Our approach has been to identify promising ingredients based on their safety profiles, regulatory acceptance, and suitability for biologic formulations," said Prof. Following proof-of-concept studies and advanced analytical evaluation in representative protein formulations, we have generated promising initial data, which is now being further verified.
Dr. Andrea Allmendinger, Chief Scientific Officer at ten23 health.
When successful, the collaboration could help pharmaceutical developers improve formulation stability, enhance manufacturability and increase flexibility during product development. Expanding excipient options may also contribute to more efficient development processes and support the design of drug products better suited to patient needs, including self-administration and improved usability.
The collaboration reflects a shared commitment by both organisations to advancing biologic drug development through scientific excellence, responsible innovation and cross-disciplinary collaboration.
Read on the collaboration in detail here.
