The afternoon sessions at the 2023 Wisconsin Biohealth Summit continued to be a platform for in-depth discussions, this time focusing on “Made in Wisconsin – Biopharma Manufacturing.” Wisconsin’s biopharma and biomanufacturing sector is on the rise, with a significant 29% expansion since 2018. The impressive growth of companies providing active pharmaceutical ingredient (API) and biologic manufacturing demonstrates the state’s strong position in shaping the future of biopharma manufacturing.
The “Made in Wisconsin” session gathered experts and panelists to share insights, experiences, and their vision for the future of biopharma manufacturing. The audience had the opportunity to learn from successful businesses and engage with the panelists.
Adam Kujath, VP & General Manager at Sterling Pharma Solutions, highlighted some key aspects of their approach to innovation in biomanufacturing. Sterling Pharma Solutions continually embraces new and adjacent technologies to enhance their service offerings, delivering superior service by applying lessons learned over their 50+ year history to all that they do. This commitment to experience ensures safety, quality, and sustainability in their processes. Sterling’s comprehensive range of scales, from the lab to large-scale manufacture, allows them to support multi-stage complex processes. Their services are rooted in a long history of development, scaling up, and manufacturing a wide range of chemical transformations, focusing on challenging and complex chemistries. Moreover, Sterling emphasizes transparency, collaboration, and trust, defining itself as a Partnership Development and Manufacturing Organization (PDMO), going beyond the traditional Contract Development and Manufacturing Organization (CDMO) model.
Lori Aschenbrenner, Director of Drug Development and Regulatory Strategy Early Phase Development Solutions at Labcorp, showcased the critical role of the early phase in drug development. It focuses on key questions such as efficacy, safety assessment, metabolism, bioanalysis, and analytical CMC, as well as environmental considerations. Labcorp’s global laboratory network offers insights to accelerate drug development, with a scientific team of more than 14,000 employees worldwide. They support over 2,100 clients across a broad range of therapeutic areas and play a vital role in central lab-supported clinical trials.
David Goeddel, Director of API R&D at MilliporeSigma Life Science Services, brought to light their expertise in API manufacturing and their potent capabilities in Wisconsin. With more than 35 years of experience in potent API manufacturing, MilliporeSigma is a premier supplier, boasting 26 commercial APIs manufactured in Madison/Verona plants. Their technological and quality differentiation, combined with their expertise in commercial linker-payload manufacturing, makes them an industry leader in ultra-high potent API manufacturing.
David shared an exciting development, showcasing a new expansion with six best-in-class single-digit nanogram/m3 OEL kilo labs, specifically designed for the safe handling of high potency APIs. This investment underscores their commitment to maintaining the highest safety and quality standards, allowing them to continue to lead in the field of API manufacturing.
Justin Koepsel, Senior Director of Commercial Operations at Catalent Biologics, brought insights from their state-of-the-art manufacturing facility in Madison, Wisconsin. Catalent specializes in cell line development, process development, analytical development, and drug substance manufacturing.
Catalent is a key player in the biopharma space, with partnerships with 41 of the top 50 biopharma/biotech companies and over 305,000 square feet of manufacturing space. They focus on various modalities, including monoclonal antibodies (mAb), Fc-fusion, enzyme, bioconjugate, Fab, and mRNA.
The “Made in Wisconsin – Biopharma Manufacturing” session at the 2023 Wisconsin Biohealth Summit demonstrated the state’s dedication to becoming a hub for next-gen biopharma manufacturing. With innovation at its core, Wisconsin’s biopharma industry is poised to shape the future of biomanufacturing, ensuring that the future of medicine is not just made in Wisconsin but made excellently. Stay tuned for more insights from the Wisconsin Biohealth Summit!