PAC Mass Spectrometry FacilityExternal Testimonials

Following an incident in a clean room manufacturing facility, it was important to ensure that the materials in the production process were analysed and checked for potential unknown materials.

What was your need?

There was a concern with the performance of the cleaning room processes and checks needed to be carried out to ensure there was no potential foreign components present in the material held in the room.

It was an urgent request as the materials were needed for the next stage of manufacture. As a Strathclyde alumni, I knew of the MS facilities available and hoped they could help us.

I was able to initiate the analyses with UoS Mass Spectrometry facility in less than 1 working day and they were able to provide the sample quick turnaround requested.

How did UoS Mass Spectrometry help you work through the situation?

UoS Mass Spectrometry had both the GC-MS and UHPLC-MS  instrumentation needed to assess the samples for unknown components. Their expertise also allowed the artifacts from the sample processing to be identified.

What was the highlight when working with UoS Mass Spectrometry?

The ability to assess samples without methodology being supplied and their experience working with “unknown unknowns” meant that we had confidence in the results. The reports included all the information that the Quality team needed to make informed decision to release the materials back into the production process.

Why would you recommend UoS Mass Spectrometry?

We were very impressed with the turnaround time for sample analyses, reporting and interpretation. The expertise in handling samples with unknown components was essential for our project.

Company Information

Terumo Aortic is dedicated to developing solutions for aortic and peripheral vascular disease. Our complete portfolio includes the treatment for thoracic, abdominal and peripheral aneurysms, acute and chronic dissections, and peripheral occlusions.

Research into inhaled routes for cannabis-based therapeutics was proving to be a challenge due to both the sample being a vapour and the need for a analytical facility which had a Home Office Licence for controlled drugs.

Challenge Faced / What was your need?

We were generating vapour samples with an artificial smoking machine to support formulation development, however the requirement to use controlled drug standards meant most laboratories were unable to perform the analyses.

We needed to do development work which GMP facilities were unable to support as the changing formulations needed the analytical method to be flexible until the final formulation was agreed.

How did UoS Mass Spectrometry facility help you overcome the problem or facilitate the situation?

UoS Mass Spectrometry had a Home Office controlled drug licence and could provide analyses with all available standards, including controlled substances. The ability of the lab to support research experiments where the vapour composition was not known enabled us to develop and refine the formulation and delivery device. UoS Mass Spectrometry qualified and transferred the final analytical method to our GMP partner lab in readiness for a clinical trial.

What was your Aha-Moment with UoS Mass Spectrometry?

Their analytical expertise coupled with the flexibility to adapt and refine the method meant we could generate samples from a range of formulations to provide the data needed to support an MHRA application for a clinical trial.

Why would you recommend UoS Mass Spectrometry?

The ability to integrate research and analytical steps gave outstanding flexibility in our development programme and we are planning our next project with UoS Mass Spectrometry.

For more information on Peter’s project please visit: www.ryahgroup.com/cannabis-clinical-trials-in-2021

https://clinicaltrials.gov/ct2/show/NCT05288010?term=cannabis&cntry=GB&draw=2

Company Information

RYAH uses a combination of smart devices and plant-based medicine databases to develop collaborations for plant-based medicines, devices and formulations.

Personal Information

Peter is a consultant process engineer within the FMCG, pharma and medical device sectors.