The Biotechnology industry is relatively young � just over 3 decades old. In this short time, it has made substantial contributions by its focus on life saving medications and cutting edge science and technology. The process development organizations have been an integral part of this industry and have played a significant role in developing appropriate processes/ analytical methods/ delivery mechanisms to aid the commercialization of these therapeutics. However, as the industry matures, so does the focus and deliverables of the PD organization. Until around the last years of the 90's, the PD organization was mainly focused on ensuring that we had a consistent and robust process that would deliver the final product reliably through tight controls � 'the process is the product'. Over the next 10 years, the focus shifted to the use of process and method platforms (especially for modalities such as antibodies and peptibodies). This allowed for faster development times, and more importantly, allowed a consistency in the manufacturing facilities that enabled easier tech transfers and more robust operations. However, over the last few years, the focus of the PD organization has shifted again. As the manufacture of mAbs becomes more commoditized and with the emergence of new modalities, the business of process development needs to adjust to allow for technologies that will allow for greater efficiencies, easier global expansions, and a focus on the patient experience. This presentation will discuss some of the technologies that Amgen - and the industry, in general � is developing, particularly in the areas of molecule assessment, process and analytical methods development, in-process and final product testing, and device development. Opportunities and challenges in the commercialization of each of these areas will also be discussed.

Process development in biotechnology: The future is already here

247th National Meeting (2014)

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