Annual Characterization of Biotherapeutics

As new product formats such as antibody-drug conjugates, multispecific antibodies and fusion proteins progress through development and into the regulatory process, the role of analytical characterization is taking on new meaning. Regulatory agencies are themselves learning about these new formats, and to support filings, industry companies are being asked to provide ever more complex data across a wide range of analytical methods.

The use of platformed analytical programs, developed as a cost and time saver by the industry, is now diminishing as novel molecules and product formats demand more individualized characterization steps. And instrumentation suppliers are striving to support this new era with unique product features, software and feature combinations. In 2014, PEGS will explore these changes in the progression of analytical development, and offer a case study forum for those working in the field to share ideas, experiences and solutions that support the development of exciting new biotherapeutics.