Analytical Methodology and PTMs will be taking place March 9-10, 2015.

Following year-on-year success, Cambridge Healthtech Institute presents a three-part event taking place March 9-13, 2014 in Baltimore, MD focusing on Analytical Methodology and PTMs, Characterization & Compliance and Comparability for Biologics.

This event covers advanced characterization technologies for a range of complex therapeutic proteins to provide a fuller understanding of the product, to ensure safety and efficacy, and to facilitate smooth and efficient interaction with the regulatory au

Ensuring quality in bioprocesses that complies with regulatory requirements and mitigates risk often results in very high bottom-line costs. Adopting best practices early in the development process and customizing these approaches to operational excellence from other highly competitive industries are currently taking place in biopharmaceutical production. This course provides both an overview of these approaches along with details about how they work, as well as case studies and data addressing how these innovations have been applied successfully in bioprocessing and the development of biopharmaceuticals. Appropriate regulatory guidance is also discussed.

The “Optimizing Media” digital course provides a detailed overview of the process for successfully developing media for culturing cells, with an emphasis on providing optimal conditions for cell growth. The overview addresses media supplementation, the importance of amino acids, protein free media, and serum versus serum-free media. In addition, the digital course includes a discussion about developing a chemically-defined basal and feed media for fed-batch cell culture, which includes strategies for optimizing basal and feed media, and developing fed-batch platforms. This presentation also highlights the use of Design of Experiments (DoE) strategies for developing basal media.

This digital course will aim to guide the researcher in designing studies for accelerated stability testing of biologics. The course will begin with basic underlying concepts governing protein drug product stability, and focus on design principles for meaning stress and accelerated stability testing of not only the protein of interest but also of excipients and primary packaging components. Strategies to handle complexities arising from their interactions will also be discussed.