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.
Biologics developers and manufacturers demand an accurate and reliable assay for host cell protein (HCP) quantitation. Let’s take a close look at why analytical scientists turn to the ELISA, and how it fits into process development.
Application Note |
By David K. Lyon, Ph.D. and John M. Baumann,Lonza
Significant interest has been focused on the science of scale for spray drying. This paper identifies critical steps that can smooth the development pathway, eliminating scale-up headaches down the road.
By Laura McAleer and Catriona Thomson,Sartorius
Many new therapies are targeting the PD-1 pathway to boost the immune response to cancer cells. Current assays used to measure the activity of anti-PD-1 or anti-PD-L1 antibodies can be highly variable due to their reliance on primary cells and complex assay protocols. One method to demonstrate the activity of anti PD-1 molecules using a functionally relevant but less variable method is using a potency ELISA.
With so many programs in and entering the clinic, Cartesian Therapeutics President & CEO Murat Kalayoglu is a great choice for a conversation on GMP expectations for phase I first-in-human trials. Learn about the company's novel approach to RNA-engineered cell therapies for oncology and beyond on this episode of the Business of Biotech. Listen now and subscribe so you never miss an episode.