Enabling Efficient Delivery of Test Material Through the Clinical Pipeline
Effective introduction of a monoclonal antibody or antibody-drug conjugate into clinical trials and final commercialization requires a defined path toward an efficient, robust manufacturing process with suitable quality parameters. In this process, efficient technology transfer between the drug-developing technology originator and an approved and authorized third party or parties is crucial.
SAFC will present the requirements of a properly designed technology transfer process and how to ensure a successful transfer and reproducible conjugation process with solid analytics, appropriate engineering design, process (quality) controls and quality assurance. Understanding which details are critical to the development of a solid CMC package and how this information gets effectively communicated between the various parties involved in the transfer process will be emphasized.
Is your ADC ready for transfer to the next clinical step?
Cynthia Wooge, Ph.D.,
Global Strategic Marketing, SAFC
Dr. Cynthia Wooge has been in pharmaceuticals for over 20 years and is now in Global Strategic Marketing for SAFC, responsible for the ADC and bioconjugation markets. Previous roles include 15 years managing Process Development with a focus on antibody drug conjugates, therapeutic proteins, and bio-organic polymers, as well as in project management and business development.
Michael Bienkowski, Ph.D.,
Manager Process and Analytical Development
Michael Bienkowski has 28 years experience in the pharmaceutical industry related to discovery and development of both small molecule and biologic drugs in multiple therapeutic areas. In his current role as Manager Process and Analytical Development, he leads the SAFC Bio-Conjugation Center of Emphasis which includes the development and production of Antibody Drug Conjugates to enable clinical evaluation.
- Identify the requirements of a properly designed technology transfer process.
- How to ensure a successful transfer and reproducible conjugation process.
- Understand which details are critical to the development of a solid CMC package.
- Communicate information effectively between various parties involved in the transfer process.
- Process Development
- Quality Assurance
- Quality Control
- Head of Manufacturing
- Head of Operations
- Head of Supply Chain Management
- Head of Procurement
