The design and development of new drugs should not be regarded as a series of discrete events, rather as a continuum of interdependent activities. This is very much the case for viral vectors, whether they are used as direct therapies or for cell modification.
These products are highly complex, and their functionality is impacted not only by their design, but also their manufacturing processes. Understanding and control of the manufacturing procedures is critical to achieve consistent outcomes, as is the control of the analytical procedures used to determine their purity and functionality.
Therefore, there is a requirement that control and scientific oversight is applied not only to the production of materials for toxicological and first in man studies, but also for the material generated for evaluation in drug discovery functions. This not only ensures that there is consistency in the quality of material used in pivotal drug discovery activities, but confidence in the study outputs and the decisions made.
The knowledge base generated from these studies supports the translation from discovery to clinical production and first in man studies, where there are defined regulatory requirements around vector production and the testing/release of material.
- The connectivity between discovery and clinical manufacturing
- Criticality of vector analytics and quality within discovery and clincial production
- The need for long term strategies linking discovery activities and clinical supplies
Dr. Audrey Chang
Executive Director, Quality Control & Analytical Sciences, Charles River Laboratories
Audrey Chang Ph.D. earned her PhD in Biology at The Johns Hopkins University; Baltimore Maryland and has over 25 years of government and industry experience in conducting biological products testing and in managing laboratories. In her current role as Executive Director Quality Control & Analytical Sciences at Charles River Laboratories, she is responsible for managing and developing a team of scientific experts that provides greater focus to the development of new services and technologies while providing technical solutions and support to clients and operating laboratories.
Technical Director, Charles River Laboratories
Tony Hitchcock has over 35 years of experience in the biotechnology industry and has spent more than 30 years in the production of complex biologics for clinical trials in the EU and US. He has worked in the areas of process development and manufacturing and has wide experience of engineering and process systems. Over the last 20 years, Tony has specialized in the CDMO field and has contributed to the development of over 30 products for clinical trials including plasmid DNA, viral vectors, bacteriophage products, and recombinant proteins from microbial, mammalian, and insect cell sources.
Director, Sales - Biologics, Charles River Laboratories
Brian Fry, Director, Sales - Biologics, Charles River has over 16 years of experience in the contract development and manufacturing industry with a heavy focus on biologic drug development. Prior to joining Charles River in 2014, Brian began his career as a Business Development Manager for a reputable pharmaceutical company. Brian’s continuous growth within the Biologics sales segment of Charles River has enabled him to seamlessly guide clients through various complex requirements throughout the drug development continuum. Brian earned his Bachelor of Arts, Business Administration- Management from California State University.