Continuous manufacturing has been talked up for years as a way for drugmakers to reduce cycle times and make production more environmentally friendly. Yet while every major manufacturer has taken a close look at the model--and committed cash to their investigations--it has yet to replace batch production in any significant way.
Chemical & Engineering News revisited the benefits of continuous manufacturing and dug into why it has yet to take off in a feature this week. On paper, many of the elements needed to drive adoption are in place. Regulators are supportive of the approach, and potential cost savings are associated with moving away from the batch model. With big drugmakers desperate to take costs out of their operations, the business case for continuous manufacturing should be clear.
Weighing against the lure of lower costs is the uncertainty of the new. Batch production has worked for years. It is a safe choice for risk-averse executives, and capacity is already available. "The biggest thing holding us back is that we have assets in the ground," James Bruno, president of consultancy Chemical & Pharmaceutical Solutions, told C&EN. The business case becomes less clear when it calls for new capacity to be built for a somewhat unproven technology when tried-and-tested plants are available.
With manufacturers generally being reluctant to take the risk of changing the processes used for an approved product--and unwilling to invest heavily in capacity for developmental drugs that may never reach the market--continuous production has remained on the fringes. All Big Pharma companies have groups looking at the technology--and have invested an estimated $1 billion over the past decade--but continuous manufacturing equipment suppliers report that CMOs are currently their main customers.
Even so, use of continuous manufacturing is slowly, quietly growing, and as it does some of the old uncertainties will fade away. Confidence in the predictability of the regulatory process should grow as more companies engage with FDA. "We have seen a little bit of everything related to continuous manufacturing. … [W]e have seen companies looking to put continuous manufacturing in for both existing products and for new products," the FDA's Christine Moore said.
- read the C&EN feature