Complex Parenteral Drug Manufacturing — A Foundation For Success

By Kurt R. Nielsen, Ph.D., President and CEO, Pharmaceutics International, Inc (Pii)

Developing and manufacturing complex parenteral drugs is one of the most difficult processes in the pharmaceutical industry, it requires a great deal of skill, firsthand knowledge, and attention to detail and still the risks are significant. When adding the complexities of a highly potent compound, an aseptic environment, small amounts of API, or a combination product of a drug in a medical device, risks increase and so does the need for even greater levels of skill and knowledge to assure success.

Based on my personal experience, and the decades of collective experience among the people with whom I work, successful drug manufacturing for the kinds of complex products described above is built on a solid foundation of skilled professionals, quality systems, and comprehensive risk management. A foundation like this creates an organizational culture that has the confidence to efficiently address the inevitable challenges associated with complex parenteral drug manufacturing and be successful.