ARTICLES BY KEVIN WALL
3 CMC Mistakes That Could Cost You Billions
The end game for many small biotech startups is acquisition by Big Pharma. How should small biotech companies prepare their chemistry, manufacturing, and controls (CMC) documentation for due diligence review? What are the mile markers that measure how far product and process have developed? While the CMC section may not add zeros to the sales price, poorly documented development can remove them.
Choosing A CDMO: If You Can’t Answer 'Yes' To These 3 Questions, Walk Away
Choosing the right CDMO is the most important factor in the success of drug product and process development, particularly for small and virtual companies. To choose the right CDMO, you must look past the opening presentation, the facility walk-throughs, and even the compliance audit.
When Should Formal Quality By Design Documentation Begin?
When is the best time to start quality by design (QbD)? This question is asked most frequently among many small firms. A better way to phrase it is: When should I formally document my QbD activities?
Debunking The Top 3 Myths About Quality By Design (QbD)
Pharmaceutical QbD and quality risk management principles have become mainstays, but prevalent myths stymie adoption of the concepts. Dismantling those myths enables more companies to capitalize on the benefits of QbD.