When a biologics company prepares to launch a new product, it must forecast the manufacturing capacity it will need. Forecasting demand is a complex endeavor. This article explains how starting early, building options into your process, understanding the lead times, and continuing to evaluate your strategy can reduce uncertainty in your plans.
Biopharmaceutical companies take on a lot of risk developing new large molecule drugs. With more complex molecules in development, changing capacity needs, uncertain forecasts, and increased competition, the market demands flexibility and innovative approaches to address today’s new challenges.
Biologics, orphan drugs, and precision medicine are on the rise, and that means some big changes for drug development and manufacturing companies. What should pharma companies look for when navigating this new era of small-volume manufacturing? Here are some ideas to consider when developing a new manufacturing strategy.
Quickly proving efficacy in first-in-human (FIH) trials is a make-or-break milestone for cash-strapped companies whose hopes for success hinge upon just one or two molecules. Whether biopharmaceutical companies have one candidate or 100, the directive is clear: moving quickly into FIH testing is essential. But, how?