Tuesday, August 12 • 6:30 to 9:00pm
Vaccine Production & Manufacturing
This course provides an excellent overview to vaccine manufacturing with an emphasis on new technologies. Current manufacturing trends that are influencing vaccine production include cell culture-based manufacturing, disposables, aseptic operations, and rational process development. New vaccine production trends will be discussed by those in the field, including how new approaches to production are affecting the way vaccines function.
Overcoming challenges will be addressed, such as optimizing processes for large-scale production including cell line development and manufacture of novel modes of delivery, such as virus-like particles (VLPs).
Additional topics include risk-based studies, Quality by Design, and lifecycle approach to process validation and control. Finally, the globalization of supply will be explored, including its influence on process scale, facility design, product image and regulatory expectations.
- Disposable/single-use technologies
- Cell culture-based production
- Rational process development
- Lifecycle approach to process validation and control
- Large-scale production
- Supply management
- Regulatory expectations
Cancer Vaccines: Clinical Updates, New Technologies and Challenges
This short course will focus on recent developments in the field of cancer vaccines. While excitement over the use of checkpoint inhibitors has dominated the field of cancer immunotherapy in recent years, cancer vaccines have made steady progress and important advances. Because of their inherently high specificity as well as the species-specificity of the immune system, progress in cancer vaccine development has been particularly dependent upon the slow pace of human clinical trials. In spite of this, there has been a large increase recently in the number of cancer vaccine efforts. Much has been learned from the failures as well as successes that gives hope for their broader utility in the clinic.
Instructor:Eric von Hofe, Ph.D., President, Antigen Express, Inc.
- Clinical proof of concept
- Different cancer vaccines modalities
- Recent clinical updates
- Case Study: HER2 vaccine to prevent relapse in breast cancer
- Immunotherapy combination
Dr. Eric von Hofe has been President of Antigen Express since April 2005, leading the development of a novel active immunotherapeutic agent to prevent relapse in patients who have had breast cancer. That compound (AE37) is currently in late Phase II development in a controlled, randomized trial. Interim results showed a strong trend toward a reduction in relapse in patients receiving AE37. During the course of those studies, the focus has been on elucidating the immunological consequences of cognate CD4+ T helper cell activation. Prior to joining Antigen, Dr. von Hofe held positions of increasing responsibility at Millennium Pharmaceuticals. He also held the position of Assistant Professor of Pharmacology at the University of Massachusetts Medical Center studying mechanisms of carcinogenesis. He received his Ph.D. from the University of Southern California in Experimental Pathology and was a postdoctoral fellow both at the University of Zurich and at Harvard. His work has been published in fifty articles in peer-reviewed journals and he is an inventor on four patents.