This begins a five-article series of “how-to†guides for tackling the most common obstacles in assessing, measuring, analyzing, and improving the performance of global biopharmaceutical manufacturing operations. Each installment covers a component of proper collection, analysis, and use of data for the best possible performance outcomes. When taken as a whole, the series should provide imperative best practices for handling business-performance data. First, consider what you want to know about your bioprocesses. How can you more appropriately measure those data…
Author Archives: Ben Locwin
Why the “Central Dogma” Isn’t
For decades, professional biology education programs, universities, community colleges, and some high schools have inoculated students with the phrase central dogma to refer to the basic paradigm that “DNA encodes RNA, which encodes for protein†(1). Although that is in large part true, we do need to break with tradition, let science take its course, and call it like it is. Background In 1970, Francis Crick’s seminal paper in Nature (“Central Dogma of Molecular Biologyâ€) was published. Eventually its premise…
Quality Risk Assessment and Management Strategies for Biopharmaceutical Companies
You’ve probably been hearing a lot about risk assessment in recent months. Indeed, some 15 times more articles have been printed referencing the concept over the past year relative to a 12-month period just three years ago. That truly represents a geometric progression. Unfortunately, very few authors have been able to disambiguate the different methods or provide insight into this time-tested, multiple-industry philosophy that at its core uses good science to make better decisions. When we undertake the challenge to…