Empowering Modern Drug Product Development: Breakthroughs in High-Concentration Formulations and Drug-Device Combination Products

WuXi Biologics explores the transformative role of high-concentration drug formulations and drug-device combination products in modern drug product development (DPD), with a focus on WuXiHigh™. As the pharmaceutical industry evolves, high-concentration formulations are becoming crucial, particularly for chronic disease treatments that require frequent or long-term administration. These formulations enable smaller injection volumes, enhancing therapeutic efficacy and improving patient compliance by making self-administration easier at home.

WuXiHigh is an advanced technology platform designed to address the challenges of high-concentration biologics, such as increased viscosity and protein aggregation, which can impact manufacturability and drug delivery. WuXi Biologics resolves these issues with innovative technologies like viscosity reduction techniques, synergistic excipient combinations, and high-throughput formulation screening. The platform supports concentrations up to 230 mg/mL and has contributed to over 100 projects, including monoclonal antibodies, bispecific antibodies, fusion proteins, and antibody-drug conjugates.

Beyond patient convenience, WuXiHigh offers significant cost advantages. By allowing smaller injection volumes, these high-concentration formulations reduce dosing frequency, potentially lowering the overall cost of goods sold (COGS) by optimizing manufacturing processes and reducing the need for healthcare professionals. This progress allows patients to self-administer treatments at home.

WuXi Biologics also operates a Drug-Device Combination Center of Excellence (CoE), specializing in the development, testing, and manufacturing of combination products like prefilled syringes (PFS) and autoinjectors. These devices enhance patient safety and compliance, especially for those managing chronic conditions such as autoimmune diseases, diabetes, and cardiovascular disorders.

In conclusion, WuXiHigh streamlines drug development from concept to market. By addressing key formulation challenges, WuXi Biologics helps clients accelerate timelines, reduce costs, and improve product stability to enable the development of innovative therapies that enhance patient compliance and convenience.