Talk Title: New software tools beg the question: Why don’t we monitor drug product profile directly?
As biotherapeutics start to dominate the pharmaceutical industry, established procass analytical technologies (PAT) are no longer adequate. Bioproduction has undergone multiple revolutions over the last decade, particularly in moving closer to real-time feedback. Compared to small molecule pharmaceuticals, the complexity of the information produced in bioreactors is enormous and the tools in use today are the preserve of specialists.
Advances in analytical tools allow researchers in development to provide detailed characterization of the drug product and variants of its sequence during process development. Mass spectrometry has been specifically identified as a tool that can provide thorough characterization of biomolecules, but the information is opaque unless mediated by an expert human, and is generally not accessible in real time. A large part of the answer lies in advanced software tools to determine the design space of “well characterized” biotherapeutics for sequence, structure, and variants.
The analytical hardware is mature enough to produce the information, but only software can distill the raw data into meaningful information that can provide the operational information as biosimilars start to pressure the market for greater efficiency. With an eye toward ensuring that the manufacturing process operates within this well characterized design space, rapid analysis and advanced algorithms and processing offer the promise to allow near real-time monitoring of the drug product profile as part of a PAT strategy or with continuous process verification.
Dr. Eric Carlson, President and CEO of Protein Metrics
Zeta Symposium 2018