A novel drug path to market is complex. Drug developers must navigate the journey, under growing pressure of regulation and competition while managing technical and financial risks. Challenges of gaining regulatory approval and transitioning production add to this complexity. Attend this webinar to understand the challenges when moving a bioconjugate candidate from clinic to market. Click here to learn more.
Lonza understands the challenges of designing a CMC strategy and has developed a structured and stepwise approach to planning that is tailored to our customers’ product, process, timelines, and risk tolerance.
Application Note |
By Ben Tyrrell and Katie Chapple,Sartorius
Targeting immune checkpoints such as the PD-1 PD-L1 pathway has proven in recent years to be an effective treatment approach resulting in a range of approved mAbs that bind PD-1 or its ligand PD-L1. In this application note, we discuss our recently developed assay format to characterize checkpoint inhibitor mAbs, specifically discussing those that target the PD-1 PD-L1 pathway.
By Dr. Wilson Bryan, FDA; Dr. Alison Moore, Allogene Therapeutics; Dr. Hari Pujar, Flagship Pioneering; Dr. Greg Russotti, Century Therapeutics; Dr. Dolores Baksh,Cytiva
Cell therapies have the potential to transform global healthcare by providing curative therapies for once incurable diseases, but there are major challenges to their widespread adoption. Industry experts share their experiences and discuss emerging trends to accelerate life-saving therapies from the bench to the bedside.
OncoSec CEO, Dan O'Connor, joins the Business of Biotech to discuss his company's development of proprietary application and injection technologies for direct delivery of its pipeline of immunotherapeutic candidates and combination therapies into the tumor environment. Listen now and subscribe so you never miss an episode.