Description
S-HiCon™ is a high-concentration formulation development platform that identifies and mitigates challenges, such as pH shifts, viscosity, and protein aggregation, while enabling the production of stable biologic formulations exceeding 200 mg/mL for subcutaneous administration. S-HiCon™ enables a systematic, rational approach to formulation development by using a structured, step-by-step process to evaluate each molecule’s behavior. S-HiCon™ helps manufacturers conduct comprehensive feasibility studies for the target concentration, including evaluations of all stability aspects and drug-delivery needs. The platform optimizes high-concentration formulations and the manufacturing processes required to produce them and creates customized workflows for different modalities.
Features and Benefits:
High-concentration biologics are not simply a scaled-up version of conventional formulation work; they pose a distinct design challenge driven by increasing molecular complexity and the need to achieve concentrations above 100 mg/mL.
As biopharmaceutical programs move toward complex modalities and subcutaneous delivery, platforms like S-HiCon™—coupled with integrated process development and analytical capabilities in a one-team model—demonstrate how coordinated early material generation, structured risk-based workflows, and advanced analytics can compress timelines and reduce technical uncertainty. This structured, data-driven screening matrix provides a repeatable process for optimizing conditions for high-concentration drug production that systematically anticipates pH-shift, aggregation, and viscosity issues early, enabling the successful development of complex biologics.