Pharmaceutical Innovations in 21st Century

Pharmaceutical manufacturing operations are inefficient and costly. Compared to other Industrial sectors, the rate of introduction of modern engineering process design principles, new measurement and control technologies, and knowledge management systems is low. Opportunities for improving efficiency and quality assurance through an improved focus on design and control, from an engineering perspective, are not generally well recognized. Quality and productivity improvement share a common element -reduction in variability through process understanding. Reducing variability provides a "win-win" opportunity from both public health and industry perspectives. And, since pharmaceutical product manufacturing technologies and practices are generally similar between both innovator and generic companies, facilitating efficiency improvements provide opportunities for both sectors of the pharmaceutical industry. An efficient and secure US pharmaceutical manufacturing sector will be essential in the 21st Century.

  • Development & approval times for orphan drugs
  • Pharmacotherapy in tissue regeneration
  • Biowaiver approaches for new drug

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