July 20, 2019
If you think about the progression of the pharmaceutical industry, the way we approach treatments and medicines has evolved tremendously in the last one hundred years. Penicillin was first discovered in 1928 by Fleming changing the way we treated infections. Twenty-five years later, Watson and Crick made the ground-breaking observation that the DNA molecule exists in the form of a three-dimensional double helix, opening our understanding of how the genetic code works. This new understanding has changed how we approach treatments for diseases. The first recombinant protein treatment was approved in 1982. The biotech industry was here to stay.
Today, over 70 per cent of all medicines in development are ‘’first in class’. Drug developers are facing more and more challenges to do everything on their own. Relying on service providers has become an integral part of the industry. Companies can focus on their R&D efforts to grow their pipelines by outsourcing process and analytical development activities to Contract Development and Manufacturing Organizations (CDMOs). CDMOs bring a wealth of knowledge and expertise from the experienced gained by working with a very wide gamut of molecules, many of which have particular challenges, intrinsic and extrinsic to the biological therapeutic target. From an economic perspective, working with CDMOs reduces the expense of maintaining a manufacturing facility and improves the efficiency of the entire supply chain.
As the industry has matured so has the need to re- evaluate how the drug developers and CDMOs work together. Transactional, fee-for-service approaches may not be the best-suited way to ensure the long-term success of a therapeutic candidate. FUJIFILM Diosynth Biotechnologies has shifted how it approaches programmes. It is not a transaction but a long-term partnership with its customers. Therapies are becoming more targeted to specific patient populations, which can lead to different supply chain requirements. Technology continues to evolve, changing how we view long-term manufacturing; for example, as cell lines become more efficient yields have increased. High throughput approaches to process and analytical development continue to evolve as new technologies become available to the cutting-edge of today’s advanced therapies – at every stage there has been a blend between using the experience of those who have done it before (many, many times in the early days) with the tangible excitement of the new. I was brought up on the stories of how stuff had been discovered that is now taken for granted and now we are creating the stories that tomorrow’s generations will build their futures upon.