- Altruist Biologics has launched Altru-CON™, a high-concentration formulation technology platform designed to support biologic drug development with concentrations of up to 200 mg/mL.
- The platform uses high-throughput screening and excipient optimisation to improve stability and reduce viscosity for biologics intended for subcutaneous delivery.
Altruist Biologics has introduced Altru-CON™, a formulation technology platform designed to support the development and commercialisation of high-concentration biologics. The platform enables protein concentrations of up to 200 mg/mL while achieving more than a two-fold reduction in viscosity.
The technology uses high-throughput screening and an excipient optimisation system that incorporates more than 30 excipient combinations. According to the company, this approach allows stable formulations ranging from 100 mg/mL to 200 mg/mL while maintaining viscosity levels suitable for subcutaneous administration.
High-concentration biologics can present technical challenges including protein aggregation, viscosity control, and long-term stability. Altruist stated that the platform addresses these issues by improving formulation stability while supporting higher drug concentrations. The approach is intended to provide flexibility in injection volumes, reduce dosing frequency, and simplify cold chain logistics while supporting drug substance and drug product manufacturing within CDMO and contract manufacturing programs.
“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.”
Dr. Kaisong Zhou, Chairman and Chief Executive Officer of Altruist Biologics
The company noted that its structured formulation development approach includes screening of more than 40 buffer systems to predict viscosity and aggregation risks. To date, Altruist has supported one approved high-concentration product, two late-stage clinical programmes, six early-stage clinical programmes, and ten preclinical projects using its formulation and contract manufacturing capabilities.
