CatSci Ltd Expand Capabilities to Offer Expert cGMP Analytical Development Services
21st November 2023
CatSci Ltd, an award-winning innovation partner for medicines development, are thrilled to announce the launch of their expert cGMP Analytical Capabilities in Dagenham, UK. CatSci’s new offering will provide the highest-quality GMP analysis for both small molecule and oligonucleotides to their customers worldwide. It includes advanced, digitally-enabled method development and innovative problem solving, whilst being fully compliant with ICH requirements.
CatSci’s cGMP Analytical capability will be led by Dr Sam Whitmarsh and Duncan Thompson, CatSci’s Director of Analytical Science and Digital Transformation, and Head of Dagenham site respectively. Sam and Ducan hold over 40 years of collective GMP technical experience at AstraZeneca and GSK. Dr Nigel Richardson, CatSci’s Director of New Modalities, will lead the analytical development of oligonucleotides. Nigel has decades of experience in the oligonucleotides space, having previously led GSK’s oligonucleotide therapy for Duchenne Muscular Dystrophy into the final stages of development and regulatory submission. Our QP Consultant, Kate Smith, QP, will also oversee all quality aspects. Kate has over 20 years of experience within the medical device and pharmaceutical industry, including human and veterinary medicines for marketed and clinical use with a wide range of dosage forms.
CatSci’s analytical team will provide ICH Q14 aligned method development and validation, ICH Q3D elemental analysis, batch release, ICH stability testing, extractables and leachables, and oligonucleotides analytical development.
CatSci’s GMP facility is fitted with the latest high-end analytical equipment through a collaboration with Shimadzu Corporation, with validated connected CDS and LIMS system to maintain data integrity. The laboratories and expert analytical team ensure CatSci can deliver the highest-quality analytical data and critical interpretation to customers, whether they are looking for full pipeline support or standalone projects.
The expansion into offering high quality GMP Analytical Development services is the latest step in CatSci’s evolution as they continue to enhance their capabilities to add strategic value to their customers’ projects. The need for solving complex analytical problems and meeting the ever-evolving regulatory demands is growing alongside the development of new modalities, such as oligonucleotides and cannabinoids.
CatSci’s Chief Operating Officer, Dr Jerome Theobald, said: “The launch of our GMP analytical capabilities is an incredibly exciting and important milestone for CatSci. Our state-of-the-art facilities, coupled with our expert analytical team, will ensure we deliver on our commitment to providing excellence in analytical development. This will enable our customers to expedite the delivery of their life-changing medicines to patients.”
CatSci’s Director of Analytical Science and Digital Transformation, Dr Sam Whitmarsh, said: “Analytical science has always been at the core of CatSci's commitment to innovation and quality. After much hard work by our amazing team and a great partnership with Shimadzu, I am excited to launch this new chapter for analytical science at CatSci. The opening of our state-of-the-art GMP analytical facilities is not just a new space, it is a commitment to tackling key analytical challenges facing our customers, from method development and validation to oligonucleotides and trace analysis.”
CatSci’s Head of Analytical Site in Dagenham, Duncan Thompson, said: "Building a GMP analytical facility from the ground up has enabled us to evaluate and adopt best practise and digital workflows from the start. That coupled with the latest high-end equipment and an expert team, possessing both breadth and depth of analytical experience, will enable us to exceed customer expectations, accelerating medicine development and benefitting patients in need." Ends
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CatSci Ltd - Caitlin Bourton: email@example.comNotes to EditorsAbout CatSci Ltd
CatSci Ltd is an award-winning innovation partner, dedicated to breaking down the silos in small molecule and oligonucleotide drug development to accelerate the delivery of life-changing medicines to patients in need. We proudly serve customers across the globe with projects, meeting their needs from candidate selection to product launch and beyond. Our tailored services include route scouting and selection, initial scale-up and risk management for early development. For later development, we provide process design, assessment and optimisation, scale-up for clinical and commercial manufacture, tech transfer and post-approval improvements. We possess a range of critical enabling technologies including catalysis, material science, pre-formulation, GMP analytical development and HPAPI development.
Agile, commercially minded and scientifically led, CatSci leverages its highly qualified technical team and state-of-the-art facilities to empower our customers to create affordable, best-in-class small molecule therapeutics in a safer, greener and more cost-effective way. Together, we can meet the evolving healthcare needs of the world.
Recent recognition includes the highly esteemed Queen’s Award for Enterprise: International Trade 2022, the 2022 Bionow Awards (Export of the Year), the 2022 Inspire Business Awards (Business of the Year (25+ employees)), the 2022 Wales Business Awards (Workplace Wellbeing), the 2022 Wales STEM Awards (STEM Company of the Year (50+ Employees) and STEM Ambassador of the Year), and the 2022 Cardiff Business Award (International Business of the Year).www.catsci.com