Pharmaceutical Production: From Batch to Continuous Manufacturing

Martin Perkins

20th June 2019

CMAC, CO2, NMR, Nuclear Magnetic Resonance, Pharmaceutical, Selected Ion Flow Mass Spectrometry, SIFT-MS,

CMAC have proof of a concept that opens up the possibility to continuously manufacture active pharmaceutical ingredients. The opportunity for continuous pharmaceutical production is big news.

See the application note here.

As a company who deal with pretty unique systems, we rely on forging relationships with likeminded individuals and organisations who move us into areas in which we can contribute to and thrive in.

CMAC definitely fall into that category of partnership that reveal some of the highly specific, high impact applications of SIFT-MS.

As the ancient saying goes, it all starts with residual solvents.

A key stage of pharmaceutical production is the removal of the solvents used to make them. This is done easily enough through the conventional method of heating the product until the offending parties evaporate.

Traditionally, the only way to find out if and when the heating process had been successful was to stop the process (thereby stopping overall production), take a sample and then analyse it using Nuclear Magnetic Resonance spectroscopy, (NMR).

While this process of stop and test ultimately does the job, it comes with significant downsides:

  • There is often unacceptable solvent residues.
  • It takes a long time for the ‘cake’ to dry.
  • The high temperatures can degrade the quality of the overall product.
  • Agglomeration which can critically affect the flow characteristics of the final product.

In simple terms it creates a bottle neck at the solvent analysis stage of production, often stopping operations by half a day. Meaning you have to produce in staggered batches to minimise the effects of stop-start production.

This is where Georgia Sanxaridou and her colleagues at CMAC saw a massive SIFT-MS shaped hole.

SIFT-MS’s extreme sensitivity gives it an incredibly wide dynamic range and has the sensitivity to measure from low parts per billion up to 100s of parts per million concentrations in real-time. Meaning it’s no longer necessary to make product in batches, cook off the solvents until it’s likely they’re gone, analyse a sample, then respond accordingly. Rinse, repeat.

The addition of real-time monitoring to supercritical CO2 extraction opens up the possibility of continuous manufacturing which is a significantly less wasteful and simpler way of doing things.

It’s the way most other consumer goods are produced.

Georgia from CMAC will be presenting her work at the SIFT-MS Interest Group Meeting on the 9th-10th of July at the Hotel Felix, Cambridge.

We’re only scratching the surface of the significance that accurate, real-time polar and non-polar molecule measurement is having in a variety of contexts. This event is by far and away your best bet to get up to scratch.

For more information on what Georgia and many others will be talking about, click here.

Email now to book your place or CONTACT US for more information