05.09.25 -- What FDA Draft Guidance Tells Us About In-Process Control Strategies

ADCs are transforming cancer treatment by targeting tumors directly to reduce side effects. Discover how they affect neighboring cells, which can enhance treatment efficacy and eliminate tumor cell populations.

When it comes to bispecific antibody (BsAb) manufacturing, a well-optimized culture environment is essential for achieving high and consistent BsAb yields with the desired critical quality attributes.

Learn about a modeling approach employing artificial neural networks using experimental factors combined with simulation-derived parameters plus viscosity data from 27 highly concentrated mAbs.

Needle innovations, including the usage of shorter needles with ultra-thin wall technology for prefilled syringes, support the delivery of drugs with greater volumes and viscosities.

Discover how implementing a strategic approach to optimize the platform can establish a solid foundation for the efficient, reliable, and successful manufacturing of biopharmaceutical products.

This presentation discusses the shift in pharmaceuticals from small-molecule drugs to protein biologics and the associated challenges, particularly the immunogenic response.

Glycosylation, a prevalent modification of mAbs, significantly impacts their function. Delve into various techniques for analyzing released glycans and their relative efficacy in HILIC-FLR-MS.

Recognizing the increased complexity of biologic analyses, as compared to small molecule drugs, can help avoid unnecessary complications and prevent cost overruns.

Discover analytical strategies designed to address challenges occurring during development of new molecular formats such as chain assembly, multiple-MoAs, and diverse post-translational modifications.

Learn about a novel solution dramatically improving the purification and yield of promising nanoscale vesicles for medical applications.

Explore how a fully integrated, U.S.-based supply chain strategy can help you navigate potential tariff risks, reduce complexity, and strengthen resilience in pharmaceutical development.

Using cGMP grade reagents earlier makes for a seamless transition while maintaining quality and viability.

Learn how to build a resilient supply chain to navigate today's complex environment. Expert speakers share insights on optimization, innovation, and strategic planning to meet evolving market conditions.

Although polymer bags are an excellent choice for cold chain use, not all polymer films perform the same way, even if their specifications rate them for use at low temperatures.