Development of Next-Generation Biologics
New therapeutic formats such as ADCs, bispecifics, fusion proteins, and cell and gene therapeutics are starting to take center-stage in many drug development companies’ pipelines. These new therapeutic modalities, however, are challenging the companies’ bioprocess, analytical and CMC groups due to the adoption of new science, lack of platform technologies, and increased scrutiny from regulatory agencies. The weeklong Development of Next-Generation Biologics stream will bring together over 40 case studies and lessons learned on overcoming the technical and scientific challenges and advancing these novel biotherapeutics from clinical to commercial manufacturing.
CMC Strategies for Antibody-Drug Conjugates
Process Development for Novel Biotherapeutic Formats
Cell Therapy Bioproduction