Webinar Date/Time: Thu, Feb 22, 2024 11:00 AM EST
Learn how to address challenges during the development of high protein concentration formulations, which have become an increasingly popular therapeutic class, using the WuXiHighTM platform and the experiences from various case studies.
Of the total commercially available monoclonal antibody (mAb) therapeutics on the market, approximately one third are considered high concentration drug products, with the highest protein concentration approved by the U.S. Food and Drug Administration (FDA) standing at 200 mg/mL. High concentration biopharmaceuticals have become a fast-growing class due to several advantages, especially for frequent or long-term administrations (e.g., chronic disease) that include lower volume delivery requirements, potentially greater therapeutic effect, and reduced cost of goods. In addition, high concentration formulations benefit subcutaneous (SC) administration if the drug products can be filled into a prefilled syringe (PFS) or autoinjector thus eliminating the need for professional health care practitioner or hospitalization and potential self-administration at home.
However, many challenges exist in both formulation and process development of high concentration drug products. The difficulties in developing these products are due to a myriad of protein-protein interactions that become more pronounced as protein concentrations increase. To provide a more efficient, and effective means of developing these high protein concentration products, the WuXiHighTM platform was established by the WuXi Biologics Drug Product Development department to address these problems. The WuXiHigh proprietary platform, incorporates features such as novel viscosity reducers, synergistic excipient combinations, high-throughput formulation screening strategies, and computer-assisted formulation development that revolutionizes the development and manufacturing of biologics and biologic-device combination products with protein concentrations >100 mg/mL. To date, the WuXi Biologics’ WuXiHighTM platform has provided high concentration formulation development and manufacturing solutions to over 70 projects (up to 200 mg/mL and across a wide range of viscosities) for various modalities (e.g., monoclonal and bispecific antibodies, fusion proteins and antibody drug conjugates).
This webinar will address the challenges of developing high protein concentration formulations and provide multiple cases studies utilizing the WuXiHigh platform that successfully overcome the obstacles associated with this growing product class.
Key Learning Objectives:
Who Should Attend:
Regulatory agencies and policymakers focused on the approval and safety of high concentration biopharmaceuticals.
Senior Vice President and the Head of Drug Product Development (DPD) and the Clinical Drug Product (DP) manufacturing network
Jeremy Guo, Ph.D., is Senior Vice President and the head of drug product development (DPD) and the clinical drug product (DP) manufacturing network at WuXi Biologics. He has over 20 years of industry experience in formulation, process, and device development for biologics over a wide range of modalities including recombinant proteins at Amgen, Regeneron, and Pfizer. Jeremy received his Ph.D. from University of Utah and B.S. from University of Colorado.