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.
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 more than 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 that 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 to solve complex analytical problems and meet 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.”