Overview of Analytical Tools for Developing the Next Generation of Biopharmaceuticals
Ensuring the safety and efficacy of biotherapeutics from research to development, and then from manufacturing to quality control is essential in order to bring a product to market. Large molecules pose unique challenges for biotherapeutic analyses in that they often requires running a panel of tests to ensure product efficacy and safety. Industry efforts have evolved towards comprehensive analytical workflows that enable researchers to monitor their purity, potency, and critical quality attributes (CQAs) of highly complex and diverse biotherapeutic molecules.
This session will outline the basics of the biopharmaceutical industry and the analytical tools utilized to access the quality and purity of their products.
Learning Objectives:
- Describe the phases of biotherapeutic 'pipeline'
- Discuss the various modalities that encompass the biopharmaceutical industry and the analytical tools that routinely used to access the quality of these modalities.
- Learn the Quality by Design (QbD) approach in the development of biopharmaceutical products and process parameters to access product critical quality attributes (CQA)
Presenter: Christopher M. Colangelo, PhD, MBA (Biopharma Business Development Leader, Americas, Agilent Technologies, Inc.)
Christopher Colangelo, PhD, MBA is the Agilent Biopharma Business Development Leader for the Americas. Prior to joining Agilent, he was the 5th employee and co-inventor of the 454-sequencing platform. In 2003, Chris joined Yale University as a Research Faculty in where he mentored and supervised a research group producing 60+ peer-reviewed publications and directed core research laboratories for four NIH P30 grants, totaling over $21 million worth of research funds. In 2017, Chris joined Agilent to help customers develop, test, and implement end-to-end biopharma workflows.
