The long road to continuous manufacturing in pharma

Continuous manufacturing could have significant success in improving the pharmaceuticals supply chain, but challenges remain.

The journey to continuous manufacturing in pharmaceuticals is going to be a long one. As a recent report on another, related technology – 3D printing – made clear, the shift to continuous manufacturing in pharma has been “slow”. Most still hold to traditional batch processing methods.

That’s despite the benefits it potentially provides – proven in a wide range of other industries like oil, gas and petrochemicals. Most notably, perhaps, is efficiency: Frost & Sullivan’s report notes that continuous manufacturing can cut production time to less than 10 days (which could then be further cut with 3D printing); the US Food and Drug Administration (FDA) has estimated some drugs that take a month to manufactured through batch processing, could be produced in a day.

Linked to that, continuous manufacturing also promises to cut manufacturing costs: by up to 40 to 50 per cent, according to the US National Science and Technology Council’s Subcommittee for Advanced Manufacturing. Estimates put waste from inefficiency in the pharmaceutical industry at up to $50 billion a year.

A quality argument for continuous manufacturing

Finally, continuous manufacturing has the potential to improve quality. Reducing human input – and error – from production, it could help cut contamination and mistakes that lead to waste and product recalls. And it’s not just the technology companies making that case: it’s one reason the FDA has been keen to accommodate uptake of continuous manufacturing.

As the deputy director in the FDA’s Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, has put it: “[B]y eliminating breaks between steps and reducing opportunities for human errors during the stops and starts in the batch process, continuous manufacturing is more reliable — and safer.”

In short, continuous manufacturing could help address both drug shortages and recalls from production issues: two key supply chain challenges the industry faces.

Demand for data

So, if it’s faster, cheaper and results in better quality, why has the move to continuous manufacturing been so slow?

There are a number of reasons. One is the up front costs, with the need to invest in new equipment. For some producing small quantities, it may also be difficult to justify round-the-clock production.

But there is also the fact that the move to continuous manufacturing is demanding – and potentially risky if not handled correctly. The benefits to quality, particularly, are achieved only by building it into the continuous process at the outset – so called “quality by design”. Regulators, too, must be satisfied that the process and controls in place are adequate.

Two things are particularly important to meeting that challenge, and both were picked up on in a speech earlier this year by Stephanie Krogmeier at Vertex Pharmaceuticals.

First, is the data challenge that continuous manufacturing can bring, ensuring the right information is available to control the process and satisfy regulators. The move to continuous manufacturing and increased oversight of data are closely tied in the FDA’s approach.

Second, and possibly even more important, is leadership. As Krogmeier made clear, the move to continuous manufacturing needs commitment, and that has to start at the top. As she said: “You need the full support of management. If you don’t have someone in senior management driving this, you will fail.”