• Altru-CON™ harnesses excipient blends and expertise to maximize drug delivery and stability through high-concentration formulation.
• The platform can reduce IND timelines to under nine months and achieve stable formulation for up to 200 mg/mL subcutaneous administration.

Altruist Biologics, an Innovent Biologics subsidiary and world-class contract development and manufacturing organization (CDMO), recently announced the launch of Altru-CON™, a high-concentration formulation technology platform, designed to accelerate the development and commercialization of high-dose biologics. The platform enables protein concentrations of up to 200 mg/mL and achieves an over two-fold viscosity reduction.

As the global biologics industry advances toward higher drug concentrations and more patient-friendly delivery formats, Altru-CON™ delivers dual breakthroughs in both concentration and stability. Powered by a high-throughput screening approach and an intelligent excipient optimization system incorporating more than 30 excipient combinations, the platform enables stable formulations ranging from 100 to 200 mg/mL, while maintaining a low viscosity suitable for subcutaneous administration.

High-concentration biologics present significant technical hurdles, including protein-on-protein interactions, viscosity control, and long-term stability, which can complicate manufacturing and increase risks of immunogenicity. The platform’s enhanced concentration translates to greater flexibility in injection volume, reduced dosing frequency, and simplified cold chain logistics, while enhancing drug substance and drug product manufacturing efficiency and shortening IND submission timelines.

Additionally, Altruist integrates high-throughput screening of more then 40 buffer systems to predict viscosity and aggregation risks. This structured development approach enhances candidate selection, reduces late-stage reformulation risk, and improves overall probability of success. To date, Altruist has supported one approved high-concentration product, two late-stage clinical programs, six early-stage clinical programs and 10 preclinical projects.

Dr. Kaisong Zhou, Chairman and CEO of Altruist Biologics, said, “Altru-CON™ represents a strategic expansion of our high-concentration formulation capabilities, supporting next-generation biologics from low to ultra-high concentrations with improved stability and viscosity control. Through our integrated drug product formulation experience and client-centric approach, we are committed to supporting our partners accelerate progress and deliver advanced therapies to patients with confidence.”