09.12.25 -- STREAM Edition: Single-Use Harmonization Needs A Tune Up

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

Advocating for Merck and GSK, NewYorkBIO's Jennifer Hawks Bland faced complex legislative issues, including patent reform and the development of federal track-and-trace legislation. Bland discusses the monumental effort involved in drafting and passing novel federal legislation, which requires years of collaboration across the industry.

Discover how to reduce monoclonal antibody (mAb) manufacturing time and costs through process intensification. Learn about continuous perfusion, ultrahigh cell density banks, and more.

In this episode of "Better Biopharma," host Tyler Menichiello is joined by Adaptin Bio's CEO, co-founder, and president, Michael Roberts, Ph.D., and Duke University's Mustafa Khasraw, MD to discuss Adaptin's Brain Bispecific T-cell Engager (BRiTE) platform.

Continuous advancements in the process and payload development of ADCs and next-generation bioconjugates have the potential to progress targeted therapeutics and improve patient treatment options.

The single-use systems (SUS) takeover isn’t coming — it’s already here. Yet, despite widespread adoption and maturing SUS technologies, a surprising lack of standardization persists across the industry. The lack of standards has a far-reaching impact on both suppliers and end users of SUS, affecting implementation, life cycle management, and interchangeability. This exposes production to risks like supply chain disruptions, tech transfer delays, and costly workarounds.

Become equipped with the tools and strategies needed to strengthen your calibration efforts and better position your organization for success in regulatory audits.