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Time is Money: Reducing the biopharmaceutical discovery and development timeline by 60%

In today’s competitive market, companies do not have time to develop new biopharmaceuticals using a linear path strategy. Overlapping late stage discovery activities and early stage development is an emerging approach that provides risk reduction while accelerating timelines. In her recent presentation, Multiplexing for Efficient Product Development, BPTC’s Susan Dana Jones, Ph.D., Vice President and Principle Consultant, provided two case studies demonstrating how this strategy benefits companies, investors, and patients. The outcomes are superior biopharmaceutical candidates that lend themselves to easier manufacturing strategies, and shorter timelines to first-in-human studies.

This shift away from a linear pathway is made possible by the evolution of development tools. These advancements include improvements in:

· Expression technologies

· Robust host CHO cell lines

· Rapid clone screening methods

· Instrumented micro-bioreactors

· High throughput analytics/robotics

· Single use technologies

Taken together, developments in expression and purification technologies, miniaturization of process unit operations, robotics and automated analytics have contributed to reducing timelines and risk when developing an initial manufacturing process. The employment of these technologies allows the multiplexing of overlapping discovery and development activities, thus allowing what was once a linear development path to evolve into an integrate approach reducing the discovery and development timeline from 2 ½ years to 18 months.