01.30.26 -- Managing Supply Chain Risk In Scale-Up And Multisite Trials

Drug shortages have increased the burden on compounding pharmacies. Robotics and automation can streamline processes, improve accuracy, and ensure quality to address challenges.

Explore the critical aspects of GMP-grade raw materials in cell and gene therapy manufacturing, including contamination control, aseptic strategies, quality systems, and regulatory compliance.

Explore how reshoring, GLP-1 capacity demands, and integrated U.S.-based manufacturing models are reshaping CDMO partnerships in a rapidly evolving pharmaceutical market.

Gene therapy is transforming treatment for genetic disorders. With over 30 FDA-approved therapies, gain expert insight into how digital PCR enhances AAV vector precision and regulatory compliance.

Discover the dynamic field of therapeutic biotechnology, examining the intricacies of mAb manufacturing and uncovering the often-overlooked factors driving high production costs.

With increased pressure on CMC development to support shortened BLA submission timelines, mass spectrometry (MS) can be leveraged to accelerate and de-risk product and process development.

Learn how high-throughput microbial screening identifies optimal expression strains for complex biotherapeutics, significantly reducing the time required to validate computational designs.

Some membranes attract water ("hydrophilic"), while others repel it ("hydrophobic"). Here, we examine which is best for your application.

DataOps, automation, and AI are transforming regulated manufacturing from digital validation to predictive operations. Hear from industry leaders who are driving innovation across IT, OT, and Quality.

Uncover the key differences between traditional DOE and Functional DOE as Seongjin Kim demonstrates how the latter enhances bioprocess optimization through a fed-batch cell culture example.

Delve into how to choose and validate normalization strategies for western blots, avoid common pitfalls, and ensure reproducible results using proteins tailored to your experimental context.

Magnetic tweezer experiments often seek to measure changes in the extension of a polymer, a functionality useful, for example, in exploring how different enzymes manipulate polymer structures.