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Analytical Platform Methods: Caveat emptor!

The importance of passing the “Fit for Purpose” test! During early development, we use a variety of laboratory analytical methods to characterize a promising biopharmaceutical molecule. Once we “know” our molecule, our role as analytical professionals shifts as we begin supporting process development to produce material for preclinical studies and beyond....

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Learning to Speak Acronymish

A Beginner’s Guide to the Incomprehensible Dialect of the Biopharmaceutical Industry The biopharmaceutical industry generates acronyms faster than a four-year-old can ask “Why?” People making the transition from academia or other careers to this industry often feel like they have been dropped into the midst of an isolated tribe that speaks...

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Speed Can Kill: In Biotech Too!

Our industry is obsessed with speed to first in human trials. We all know the mantra – push to make the “first in man” milestone at all cost. This driver has caused companies to seek FDA’s Fast-Track designation for their development projects. Since July 2012, 516 projects have been granted...

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