Abstract
This special issue of JALA is dedicated to emerging technologies and their impact on pharmaceutical development. In this issue, pharmaceutical development refers to both drug substance development (chemical process R&D) and drug product development (pharmaceutics R&D).
Regular JALA readers might be surprised by the selection of this topic for a special issue, given the relative infrequency of past reports from this discipline among the journal's pages. As guest editors, it is our opinion that pharmaceutical R&D is currently underrepresented within the community of laboratory automation professionals. Yet, the application of automation and new technologies to pharmaceutical R&D activities is a rich area of growth and has substantially influenced how modern pharmaceutical development scientists carry out their work.
The primary stimuli for this growth can be traced to both the potential for productivity gains and regulatory pressure, because regulatory agencies, such as the U.S. Food and Drug Administration, have sought to influence pharmaceutical companies to design quality into their drug manufacturing processes. In pharmaceutical drug substance and drug product development, this translates to constructing a comprehensive and convincing body of knowledge that ensures consistent performance of a given manufacturing process. In fact, it can be said that the goal of pharmaceutical research and development is gradually shifting from one of “optimizing” processes to one of creating knowledge from which processes can be rationally designed and predictably controlled. The tools and techniques of laboratory automation are playing a pivotal role in this transition by enabling structured forms of measurement and experimentation that would not have been considered possible in the past.
In keeping with the mission of JALA, which is to provide a multidisciplinary forum devoted to the advancement of technology in the laboratory, we elected not to limit the reports in this issue to one particular theme within pharmaceutical development. Instead, we are pleased to present a collection of articles that we believe illustrates how technology impacts several of the many facets of pharmaceutical R&D. We hope you enjoy reading these articles as much as we did.
Sincerely,
Erik Rubin, Ph.D.
Thorsten Blume, Ph.D.
Footnotes