Recent advances in cancer immunotherapy have turned researcher' s attentions to new therapeutic strategies focused on improved specificity, control of key checkpoints in immune response, the identification of new biomarkers and novel ways of combining the

Assurance of quality and stability of biologic formulations over the course of intended usage is critical in developing safe and efficacious biopharmaceutical products.

The Bioprocessing Summit brings together international leaders to discuss today’s bioprocess issues from cell line selection to manufacturing.

This course provides a detailed look into the discovery, characterization, and manufacturing of Antibody-Drug Conjugates, with a particular focus on safety issues. Featured is an in-depth and extensive case study from Genentech about their use of antibody-drug conjugates in a robust bio-oncology program, including a focus on risk mitigation and risk minimization strategies. This talk is followed by a presentation about Sutro Biopharma’s Open Cell Free Synthesis (OCFS) technology for screening, selecting and formulating ADCs. Finally, an excellent overview of the infrastructure required to produce these molecules is presented by Lonza. All three presentations are filled with first-hand insights and practical approaches to successfully developing these potent biologics.

Immunogenicity Summit 2012, led by Dr Amy Rosenberg, Director of the Division of Therapeutic Proteins at CDER and Paul Chamberlain from the NDA Advisory Board, a well recognized and experienced expert in presenting immunogenicity risk assessments to European and North American regulatory agencies. This product covers product quality aspects and clinical consequences and the immunogenicity risk assessment process, and provides real examples demonstrating the application of principles and an interactive case study.

This DVD provides a great overview of affinity tags along with an excellent case study of developing tandem affinity purification (TAP)-mass spectrometry approaches to protein purification. Bill Gillette (from SAIC-NCI Frederick) has personally purified over 800 unique proteins, and generously shares his extensive knowledge and experience including interactive discussions with the course participants. Alexey Veraksa(from UMass Boston) discusses the advantages and pitfalls associated with the use of the original TAP tag and the more recently developed GS-TAP tag, and shares his group’s new data on developing even more efficient ways to isolate and analyze protein complexes.