Early Development 
Late Development 
Excellence In Medicines Development
We are a scientifically-led, commercially-minded and award-winning innovation partner, dedicated to developing economically and environmentally sustainable pharmaceutical manufacturing processes. We create tailored solutions from candidate selection through product launch and beyond, ensuring delivery of your asset at every stage through our experienced line of sight of drug development.
Why Choose CatSci?
End-In-Mind Approach
Our in-depth understanding of drug development challenges enables us to minimise risks and expedite the progress of your projects in a safer, greener and more cost-effective way. We ensure open consultation and communication in everything we do, to understand you inside out, and proactively address all your concerns and challenges to meet your evolving portfolio needs.
Partner, Innovate, Deliver
Our highly qualified team of PhD and postdoc scientists has decades of collective experience working on hundreds of non-clinical development projects for companies of all sizes and from all over the world. This allows us to expertly manage the full complexity of your small molecule, oligonucleotides and other complex medicines projects, working not only as a helping hand but as a true partner for innovation.
Agile Ways of Working
Our ways of working include adopting digital data management tools, which enable us to facilitate knowledge sharing and reduce barriers to efficient ways of working. We ensure total alignment with your internal processes and systems to alleviate any pressures of working with an external partner. Our team takes full responsibility for seamless technology transfer to your in-house manufacturing sites or third-party manufacturing organisations.
Health & Safety Commitment
We operate a system of Health, Safety and Environmental controls aligned to the rigorous standards set by large pharma to safely and securely deliver all your project demands.
Data Confidentiality and IP Protection
We guarantee complete data and information security to ensure integrity, confidentiality and total protection of your intellectual property rights.
Access To The Best Science
We leverage our partnerships across the wider pharmaceutical value chain and provide important access to the academic excellence that the United Kingdom is renowned for.
Our Capabilities
Small Molecule – Early Development
We have successfully developed hundreds of pre-clinical and Phase I projects. Using a thoroughly consultative approach we take the time to understand your objectives and identify the challenges that you face. The key areas of early development that we focus on are route scouting and selection, early scale-up, crystallisation, solid state, preformulation, high potency API development and project risk management.
We pride ourselves on utilising the latest advances in science and technology to optimise drug development and manufacturing processes from an early stage.
Early Development
Small Molecule – Late Development
Our late development work ensures that you are successfully supported through process design and assessment, scale-up for commercial manufacture, tech transfer and post-approval improvements. We can also deliver beyond our in-house non-GMP material supply in a seamless manner by working closely with your preferred manufacturer. We possess a range of critical enabling technologies including catalysis, crystallisation, solid state, preformulation, high potency API development and analytical development.
Our experienced team has successfully delivered numerous Phase II-III and launch phase projects for Top 50 pharma companies and we continue to deliver to the standards of large pharma.
Late Development
Expert Oligonucleotide Research, Development and Manufacturing
Our 40+ years of collective experience in oligonucleotide R&D and manufacturing enables us to de-risk and expedite the delivery of our customers’ RNA therapeutics.
Our CMC experience, detailed understanding of regulatory requirements and deep QbD expertise accelerate the development and manufacture of these complex molecules. We harness our dedicated analytical support and PR&D excellence to deliver projects from candidate screening and in vivo animal studies to toxicology studies. Our state-of-the art laboratory is equipped with the latest high-end equipment.
Our experienced team can synthesise all classes of therapeutic oligonucleotides, including siRNA, ASO, Gapmers, sgRNA, as well as GalNAc ligands and other conjugates.
Oligonucleotides
Our State-of-the-art Facilities at CatSci
We have 7 operational laboratories dedicated to the non-clinical development of small molecule therapeutics across our two UK sites, with our oligonucleotide suite situated in our Cardiff site. Our state-of-the-art laboratories feature the latest high-end equipment, including a 10m glove box for catalysis research, dedicated high potency laboratories and 20L vessels for non-GMP material supply, along with all requisite analytical, solid-state, and oligonucleotide R&D and manufacture instrumentation. This enables scale-up from milligrams to kilograms in-house, as well as ensuring the necessary technology transfer for GMP manufacturing to expedite project progression. Our extensive range of facilities enables us to devise, revise and optimise your chemistry with complete flexibility.
We constantly invest in and expand our bespoke facilities to broaden our range of laboratory assets to address customers’ dynamic portfolio needs. We have dedicated facilities for process understanding and optimisation, catalysis, high pressure reactions, crystallisation, process scale-up, preformulation, analytical development and non-GMP material supply. We also possess two SafeBridge®-certified laboratories for the development of potent compounds. Our GMP-analytical science laboratory in Dagenham, UK is fully equipped with state-of-the-art analytical equipment, through our collaboration with Shimadzu Corporation, providing the highest-quality analytical data and critical interpretation to our customers.
Our dedicated oligonucleotide laboratory is kitted with the latest high-end equipment, allowing us to synthesis, purify, analyse and fully optimise the synthetic and downstream process of our customers’ oligonucleotide research, development and manufacturing programmes.
View our Digital Walkthrough to take a 360° virtual tour of our facilities.
Partnering from pre-clinical to product launch
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Chemical Development
Route scouting & selection
Rapid route development & scale-up
Thermal hazard identification & mitigation
Green chemistry exploitation
Kilo-scale non-GMP & GMP material supply
Knowledge transfer for first GMP manufacture
Process design, development & optimisation
Process understanding & robustness for manufacturability
Model-led exploration of design space for process definition
Sustainability metrics
Demonstration batches
Kilo to tonne GMP material supply
Technology transfer for late-stage & commercial manufacture
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Analytical Excellence
High-throughput reaction profiling and analysis
Method development (In-silico, screening optimisation & qualification)
Impurity identification & characterisation
Forced degradation studies
Screening
SFC
Chiral
EPSA
ChromLogD
Large scale purification
Drug substance & product batch analysis (GMP)
Method validation & robustness (following ICHQ14)
Measurement of trace genotoxic impurities & trace element analysis, detailed reaction understanding & data visualisation
Stability studies
Impurity isolation
Oligonucleotide sequencing, characterisation & analysis
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Crystallisation, Solid State & Preformulation
Early solid state characterisation
Version (salt) screening & selection
Polymorph screening
Crystallisation design
Developability assessment
Pre-formulation including formulation definition for pre-clinical studies
Particle & formulation risk assessment for FTIH
Computational assessment using CCDC informatics tools
Micronisation assessment
Crystallisation development & optimisation
QbD process understanding & robustness
Control strategy for solid state & bulk properties
Comprehensive physical properties measurement capability
PAT using in-situ particle measurement & imaging
Filtration & washing optimisation
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Catalysis Experience
Reaction screening & catalyst selection, incl. high pressure reactions & biocatalysis
State-of-the-art expertise in homogeneous & heterogeneous catalysis, incl. asymmetric hydrogenation
Medium-throughput & data-rich experimental workflows
Research, development & optimisation of catalytic processes
Statistical experimental design (DoE, PCA)
Advanced data science & visualisation techniques
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High Potency API Development
Route design
Process invention & characterisation
Crystallisation, isolation & drying
Analytical method development & sample analysis
Up to 10g-scale non-GMP material supply
SafeBridge®-certified laboratory
Parallel reactor workstation technology
Process data collection
Up to 10g-scale non-GMP material supply
Analytical method development & sample analysis
SafeBridge®-certified laboratory
