May / June 2018

Evolution of the Pharmaceutical Industry

Ferdinando E. Aspesi, PhD
Evolution of the Pharmaceutical Industry

As this is my first Pharmaceutical Engineering editorial, let me introduce myself. I have been in the pharmaceutical industry for the last 41 years. Over time, I became the global head of quality for three major pharmaceutical companies. I’ve lived and worked in six different countries, but for the last 15 years I have been a resident of the Philadelphia area.

I have witnessed the evolution of this important industry from bioextractives to recombinant DNA bioproteins, from small molecules to monoclonal antibodies. Throughout these four decades, however, the industry has never forgotten the reason for its existence: our patients.

Areas Of Interest

  • Despite the transition from batch to continuous manufacturing, the industry continues to struggle with process variability. The use of flow chemistry and, in the near future, continuous processing in biotechnology drug substance manufacturing, is providing better control of our manufacturing processes as well as more consistent drug product availability and quality.
  • Materials characterization and consistent, reliable supply still need improvement. Technology is evolving in the areas of protein analysis and characterization, continuous freeze-drying, and freeze-drying heat-exchange efficiency.
  • The industry is investing heavily in IT and data management for process modeling and artificial intelligence; both are needed for a fully automated factory of the future with built-in continuous improvement capabilities.
  • Tax policies and labor costs are fueling the deployment of new technologies and products. Technology transfer and process validation continue to require high commitments of resources.
  • The industry has not yet been able to convince regulatory authorities of the importance of implementing real-time release, despite a better understanding of process design and correlation with critical quality attributes.
  • Despite ICH’s recent efforts, including Q12, we are still in a disharmonized world. Recent mutual recognition agreements are positive signs; much work remains to lift cumbersome regulatory burdens.
  • The last 20 years have seen a major technology transfer from the Western world to emerging economies. This change allows an additional 30 to 40 million people each year to spend money on medications, a trend that will drive sales growth and higher production volumes. India and China, the major recipients of these technologies, are now becoming the sources of future innovation.
  • To produce students who are well-educated in science and technology, it’s essential that we help prepare the workforce of the future to operate in a digitized economy where mathematical models, artificial intelligence, and virtual reality will be part of their daily operations.

Our magazine provides a major opportunity to disseminate the science and technology driving these changes. I encourage all of you to contribute articles that will inform and educate our members about the challenges and opportunities facing our industry.

I look forward to working with all of you to increase the reach and influence of Pharmaceutical Engineering.