Crystec Pharma

Shortlisted:
Sustainability in Manufacture

Modified Supercritical Anti-Solvent (mSAS®) Particle Engineering Platform for Green Pharmaceutical Manufacturing

Crystec Limited (CrystecPharma) is a crystal and particle engineering company applying its proprietary, green mSAS® (modified Supercritical Anti-Solvent) technology to enable drug molecules to be crystallised in new forms and novel particles to be manufactured in ways that greatly enhance their therapeutic performance, whilst reducing environmental impact.

It is widely acknowledged that the pharmaceutical industry is a major contributor to emissions damaging to the environment. Crystec’s manufacturing technology is a rapid, single step process; it requires less energy and solvent and generates much less waste than conventional pharmaceutical technologies.

Globally, the pharmaceutical industry emits greenhouse gases with an intensity over 55% higher than the automotive industry. The mSAS® process uses 27% less solvent than micronisation, and 80% less solvent than spray drying. With on average a 95% yield, mSAS® is 40% more energy efficient than spray drying and 80% more efficient than micronisation, measured in kWh per g. Crystec’s ‘in-particle design’ means less solvent waste, higher yields and quicker development times. Figure 2 (below) shows mSAS® compared to batch crystallisation and spray drying of paracetamol in methanol at 2 L scale, to produce at least 220 g. Figure 2 (attached) shows mSAS® compared to batch crystallisation and spray drying of paracetamol in methanol at 2 L scale, to produce at least 220 g.

The mSAS® platform was originally developed in 2008 to solve particle size, shape and morphology challenges with small molecule development, particularly in the field of inhaled therapeutics (see Appendix 1), and as a technology to help reduce environmental impact in the industry. Over recent years, large molecule therapies have become increasingly popular, now representing over 30% of new product approvals. However, typical processing methods employed, such as spray drying and lyophilisation, carry a significant environmental burden as well as introducing many challenges.

In 2020/21, to extend its green offering, Crystec undertook a project to explore the applicability of the mSAS® technology for the large molecule market. It was found that mSAS® provides a superior alternative for generating dry, highly stable, free-flowing powders of biomolecules through controlled processing, enhanced drug loading and stability, efficient dehydration, co-processing flexibility, and scalability and regulatory compliance. Most importantly, these powders require less (or no) refrigeration, reducing the environmental impact of pharmaceutical supply chains.

Today, the mSAS® technology is deemed to be both an innovative and highly sustainable solution for processing both small and large molecules, and many clients (new and existing) are embracing this. Since 2022, Crystec has been working on projects involving both small and large molecule therapeutics. Furthermore, at the time of writing [February 2025] , Crystec has a 100% success rate for projects completed on biomolecules where the client’s problem was solved.

The mSAS® platform is readily scalable and therefore has the potential to further reduce the environmental footprint within the industry. We have capabilities to rapidly scale product development and manufacture from initial laboratory experiments on precious research material all the way through to commercial Good Manufacturing Practice (GMP) scale.

It is the company’s vision to establish additional scale-up capacity in Bradford, ideally on-site at its existing premises, to provide a seamless and sustainable facility that meets increasing client demand. Above all, the mission is to foster wider adoption of our technology across the industry, bringing greater benefits to patients while reducing the burden on our planet.

Crystec’s mSAS® particle engineering platform should win this award because it is:

1) A green manufacturing process
2) Technologically superior to traditional methods
3) Provides rapid development capability

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