Description

Living inside every person are trillions of bacteria and other life forms that make up the microbiome. Novel therapeutics using living bacteria—known as Live Biotherapeutic Products (LBPs) derived from the microbiome—are being developed to prevent, treat, or cure diseases such as gut, neurodegenerative, and psychiatric disorders, infections, infertility, and cancer. This burgeoning field presents unique manufacturing challenges and quality control considerations. Unlike traditional pharmaceuticals, LBPs are alive. Maintaining viability through the entire manufacturing process is critical. In addition, live bacteria in the product make standard microbial tests (compendial methods such as USP <61>/<62>) inherently problematic; high concentrations of the product strain can overwhelm testing media, mask contamination, or render filtration methods unusable. Learn how List Labs is tackling these challenges—including developing tailored processes and organism-specific quality control methods—to harness bacteria’s potential for a healthier world.

PRESENTERS

Nuria Gonzales, Director of Biologics Development

Sarah Henning, Sr Manager of Quality Control
Sarah Henning is the Senior Manager of Quality Control at List Biological Labs, where she specializes in QC method development for bacterial products and recombinant proteins. With nearly a decade of experience in public health and pharmaceutical microbiology, she is passionate about advancing the field in Live Biotherapeutics. A key opinion leader in the industry, Sarah recently presented at a national conference for microbiome research, sharing her insights on creating novel processes for contaminant detection and ensuring product safety. When not at the office, you can find her exploring the California coast with her two dogs, playing volleyball, and volunteering for a local animal sanctuary. Connect with Sarah on LinkedIn.com/in/sarahchenning