Biopharmaceutics execution

Additional safety studies may be required to support the movement into new indications, and the complex designer biopharmaceuticals will continue to require creative approaches to safety assessment. In either case, the requirement for, and design and execution of, those studies should be driven by sound scientific rationale. Ultimately, the objective of preclinical safety evaluation is well articulated in ICH S6 ... 

Sarfaraz K. Niazi is the Chief Executive Officer of Pharmaceutical Scientist, Inc., Deerfield, Illinois, and is a consultant to the pharmaceutical and biopharmaceutical industry worldwide. The author of more than fifteen major texts in the field of pharmaceutical sciences and over 100 research articles. Dr. Niazi received the M.S. degree in biopharmaceutics in 1971 from Washington State University, Pullman, Washington in 1971 and the Ph.D. degree in pharmacokinetics in 1974 from the University of Illinois, Chicago. He is also licensed to practice before the US patent and Trademark Office and owns several US patents for his inventions. 

In this prechnical phase a lot of other development work packages also have to be executed. Most important for the biopharmaceutical dmg substances is the development of the manufacturing process, and the respective analytical methods to be used to characterize process intermediates and the final product, especially with regard to their purity (impurities) and stability (see also Part I, Chapter 6 and Part VII, Chapter 1). 

Future developments in the biopharmaceutical industry are likely to impact the scope and execution of process validation activities. The nature of process validation is continuously changing to meet the requirements of biopharmaceutical development and manufacturing. The understanding and implementation of new strategies based on future developments is key to maintaining an effective process validation methodology. 

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