Pharma Integrates

What will tip the scales towards continuous manufacturing?

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/AlSimonov)
(Image: Getty/AlSimonov)

Related tags: Continuous manufacturing, Ema, Fda

A closer partnership between CDMOs and pharma companies could share the risk of innovation, suggested one pharma director.

A discussion on how industry could speed up the adoption of continuous manufacturing (CM) occurred at Pharma Integrates last week.

Jon-Paul Sherlock, global technology strategy director for manufacturing science and technology at AstraZeneca, stated that it would welcome contract development and manufacturing organisations (CDMOs) investing in the area.

“One of the on-going challenges is how do we bring forward this technology in partnership with a CDMO? It would be desirable to see innovation through the CDMO space, as well. You have to take the risk but we need to think of better ways to partner to get that innovation happening and moving forward,” ​said Sherlock.

Phillip Gabb, group sales director of GEA Group, which produces processing equipment for the pharma sector, observed that he had also seen a lot of investment from the big pharma area but found smaller companies to be “sitting on the sidelines, waiting to see what happens.”

“There's interest but are they prepared to put their hands in their pockets? At the moment, no. My concern is that we will be hit with a tsunami – where demand far exceeds supply [of processing equipment]. From a supply point of view, it would be much nicer to have more predictability,” ​he continued.

Regulatory helping hand

Another focus area concerns regulatory bodies and their role in industry adoption – a topic which has previously led to criticism of agencies’ coordination​ in the area.

Mark Birse, group manager of device safety and surveillance at the Medicines and Healthcare products Regulatory Agency (MHRA), said that the MHRA spends more time working with other stakeholders, as a result of industry feedback.

“We work with other stakeholders and other regulators internationally to try to smooth our approach, particularly in this space. There's a lot of work we've done across Europe and with the US FDA (Food and Drug Administration), in terms of going out to sites to see how the industry is implementing the process,” ​he explained.

He also stressed that a big part of the MHRA’s role is to aid in educating industry to develop their CM approaches, as well as to work out where additional regulation can be helpful.

Sherlock admitted that, previously, regulators had been used as a “scapegoat” ​by industry but believed that many have now “come around to the fact that they are supportive”​ in helping develop CM.

However, he continued to suggest that a lack of harmonisation across regulators, beyond the FDA and the European Medicines Agency, still acts as a “major blocker”​ to adoption.

On future use

When will all of these factors combine to see wider adoption of CM technology? One industry consultant gives the industry a 10-year timeline.

What the future will look like is another question; Birse noted that he did not expect CM to completely takeover from batch production.“Continuous and batch are two key processes, I think we need to develop both and make sure we are using the best of both. There is an awful lot of development going into continuous but a lot of other industries still do batch, mixed with continuous,”​ he said.

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