This session is a continuation of Wednesday’s Speed to Patient Plenary Session. This session includes talks on novel strategies for manufacturing and testing products. It will also include a session from the EMA to discuss opportunities to gain approval for these novel strategies…
Industry and regulatory authorities speed of response to the COVID-19 pandemic crisis demonstrated the capability to develop new therapeutics in the face of a dire situation…
Supply of raw materials has been a risk to the biomanufacturing industry for many years, however, the pandemic has worsened and accelerated what is now no longer a risk but a reality…
Use of animals and/or animal derived products to demonstrate safety or efficacy supports drug development and, in some cases, is required by law to release drug product…
Continued progress in the development of sensitive and high-resolution analytical technologies have enabled significant progress towards the goal of a Well Characterized Biological Product…
“Alone we can do so little, together we can do so much” is a Helen Keller quote which captures the spirit of CASSS-organized conferences like WCBP, the regional CMC strategy forums, and technology specific meetings…