High Quality GMP and Non-GMP Analytical Services at CatSci

Analytical Expertise

At CatSci, we understand the importance of providing the highest quality analytical data so our customers can bring their life-changing medicines to patients, quickly and safely.

You can rely on:

Our senior analytical leaders with over 70 years of collective GMP technical experience
An experienced QA manager overseeing all quality aspects
Our expert chromatographic services from small scale research to large scale manufacturing
Automated screening systems in both HPLC and SFC modes for both chiral and achiral compounds, that can screen over 150 method conditions in less than 24 hours
The latest high-end laboratory analytical equipment with validated connected CDS and LIMS system, maintaining data integrity
Full compliance with ICH requirements
Controlled substances – Schedule 1 and 2 compliant
Workflows for both small molecules and oligonucleotides

These make us a perfect partner to address any of your small molecule, oligonucleotide, and complex synthetic medicines project needs, whether it is full pipeline support or standalone analytical projects.

We deliver value-adding data packages and solutions aligned to the latest version guidelines. From preparative chromatography, ICHQ14 aligned workflows for throughout the lifecycle of a method, ICHQ3D elemental analysis and batch release to ICH stability testing, extractables and leachables, and oligonucleotides analytical development, CatSci is the analytical partner that you can rely on.

Discover our Analytical Science Offerings

Analytical Science - blue toned image of Analytical Science laboratory

Method Development & Validation

We believe the analytical method lifecycle values of ICH Q14 and USP <1220> should be woven into each and every process. That is why we offer bespoke method development, validation, risk assessments and method control strategies tailored specifically to your project needs. We employ digital workflows to reduce method development time and enable detailed understanding of the method parameter space.

Oligonucleotides

The analysis of Oligonucleotides is a science in its own right. At CatSci, you can leverage our 40+ years of collective experience in Oligonucleotide synthesis and analysis. Whether it is complex sequencing and structural characterisation of novel 100mers, method development and validation for commercial manufacturing, or batch release and impurity analysis of starting materials, we have the expertise to deliver your project.

Extractables & Leachables

Our comprehensive offering enables you to understand the potential impact of extractables and leachables to your project. The effort deployed into understanding the risk profiles in API and drug product must be mirrored in the understanding of risks derived from packaging and storage, whether that is in production or product. The unexpected is not acceptable, patient safety always comes first.

Analytical Development at CatSci - blue-toned image of lab equipment

Trace Element Analysis

As we strive for safer medicines, reduced regulatory limits lead to ever more sensitive analysis. CatSci is fully aligned to ICH Q3D requirements and can deliver the low-level measurements of trace elements in a variety of sample matrixes.

Structural Characterisation, Investigational Analysis & Troubleshooting

Unknowns waste precious time and resources. Whether that is clinical trials, manufacturing campaigns, or research programs, we understand the cruciality of hitting your critical milestones. We do not just send you data, our experts take ownership of the analytical challenge and work with you to stay on track, on budget, and to keep patients safe.

Blue-toned image of Analytical Science laboratory and equipment

Drug Substance & Product Batch Release

We offer fast turnaround GMP services for small molecule pharmaceuticals to keep your delivery on track and prevent delays with your manufacturing batches, whether for clinical trials or commercial batches.

Analytical Science - blue toned image of female scientist in Analytical Science laboratory

Stability Studies

We offer stability studies to help our customers through IND and NDA submission, with the highest-quality data that you can trust. Our GMP Analytical Science services are core to this. We also offer a wide range of non-GMP physical property testing to build your knowledge base.

Discovery

From rapid method development and analytical support, to isolation of key target molecules, we understand that speed is priority for keeping your Discovery Project on track. By utilising a wide range of stationary phases, we are able to solve a variety of chromatography challenges. Whereas through proficient use of SFC, we can deliver high-purity chiral material within just a few days of receipt of racemate.

Large Scale

As projects move forward, demand for several hundred of grams of pure target molecule(s) becomes essential. Utilising the latest SFC instrumentation, we are able to process hundreds of grams of crude material a week – allowing chromatography to be a viable route for scale up. Our large scale facilities can also be utilised for impurity isolation, where SFC and HPLC can be used in tandem to process large amounts of API in order to isolate unknown impurities as low as 0.01% at high purity for characterisation.