We recently sat down with Dr. Jeremy Guo, Ph.D., SVP, Head of Drug Product Development & Clinical DP Network, WuXi Biologics, to discuss both the challenges and innovations associated with developing high-concentration protein formulations. High-concentration formulations, which typically exceed 100 mg/mL, are essential for subcutaneous or intramuscular administration, shorter treatment times, and patient convenience, especially for chronic diseases like rheumatoid arthritis and various cancers. However, increasing the protein concentration introduces challenges such as increased viscosity and protein aggregation, which in turn impacts the manufacturability, stability, and delivery of drug products (DPs). Dr. Guo explains that these challenges are particularly pronounced when scaling up production and during the drug delivery process, where issues such as filtration and sterility assurance come into play.

To address these issues, WuXi Biologics developed WuXiHigh, a high-throughput technology platform that customizes formulation development strategies for high-concentration biologics. WuXiHigh employs molecular dynamics simulations, proprietary viscosity reduction strategies, comprehensive analytical techniques, and other advanced tools to ensure the stability and efficacy of high-concentration formulations. By integrating these tools, WuXi Biologics can develop formulations for a wide range of biologics, including monoclonal antibodies (mAbs) and fusion proteins, and optimize them for drug delivery devices like prefilled syringes (PFSs) and autoinjectors. Our comprehensive approach ensures that the formulations are compatible with delivery devices, enhancing patient compliance and reducing overall treatment costs.

To listen to the podcast, please see Developing High-Concentration Protein Formulations via WuXiHigh™ – Podcast (wuxibiologics.com)