Digital Lab Walkthrough

Welcome: Transcript

The CatSci Way

Hello! My name is Ross Burn and I am CatSci’s CEO. Our customers can now leverage both our expertise in small molecule drug substance development and manufacturing and Oligonucleotide R&D and manufacturing.

At CatSci, we are passionate about breaking down the silos in drug development to accelerate the delivery of life-changing medicines to patients in need.

We pride ourselves in being perfect-for-purpose, meaning that we will always tailor our solutions specifically in response to our customers' needs and treat each and every project as if it were our own. Essentially, we seek to be a seamless extension of our customer’s internal capability and capacity.

I am very proud of the team here at CatSci. Our ethos is to support and develop each other in order to be the best scientists that we can. Please take the rest of the tour and meet my fantastic colleagues.

Our ways of working: Transcript

Your Innovation Partner

Hello, my name is Sam and I’m Director of Analytical and Digital here at CatSci

CatSci has 9 state-of-the-art laboratories in Cardiff and Dagenham dedicated to the development of new medicines. We have specialist facilities in: Process R&D, catalysis, high pressure reactions, crystallisation, preformulation, analytical development and non-GMP material supply. We also have a SafeBridge®-certified high potency lab allowing us to work on highly potent OEB-5 materials. One of those 9 labs is also focused on the development of oligonucleotides.

Through our partnership with AGC Pharma Chemicals we provide scalable small molecule API manufacturing, from grams to tonnes, with complete accountability of the whole tech transfer process.

Of course, having great facilities means nothing without having great people and that is one of the best things about working at CatSci. We have a team of expert scientists truly dedicated to delivering great science, and getting medicines to patients in need. Around 80% of the team are PhD qualified and many have large pharma experience.

Each of our projects has a dedicated strategic account leader who supports the overall relationship, and a technical project leader in that scientist to scientist role who acts as the primary contact for project delivery. We always provide a fully tailored technical report to transfer knowledge and can combine that with other digital technologies such as video tech transfer.

CatSci is constantly evolving to become a “Digital First, Intelligent Automation Next company”, freeing up the hands and minds of our talented scientists to solve our customers’ drug development challenges.

Crystallisation: Transcript

Perfect For Purpose

Hi, I’m Jo, and I am one of CatSci’s Group Leaders for Process Invention.

Here at CatSci, we are the trusted partner of global large pharma and biotech companies, in the US, EU and Japan and our expert team have worked on the development of over 100 therapeutics.

The last year has seen a huge amount of internal investment in facilities at CatSci, enabling us to develop better chemical processes for our customers. Our new chemistry lab facility is equipped with parallel workstations, such as Integrity10, EasyMax and Mya4, and interchangeable reactor-vessel platforms. To enhance our capabilities to simulate scale-up, we have invested in continuous solvent evaporation equipment and Nutsche Filter driers. Our facility is equipped with automated sampling technology, automated dosing units, and reactor control panels, to enable CatSci scientists to run data-rich experiments for our customers. We also routinely utilise reaction modelling and experiment design software (such as JMP, Dynochem and Reaction Lab), to expedite our process development and support reaction understanding.

At CatSci, safety is paramount. Prior to any scale-up, we always conduct a risk assessment as well as obtaining calorimetry and DSC data. Our process safety workflows are embedded in our working culture, ensuring we are both protecting our scientists and developing safe, sustainable processes.

Our end-in-mind approach along with our passion for science, enables us to deliver perfect-for-purpose solutions that balance timelines and internal resources with maximum flexibility.

Process R&D: Transcript

Safe and Secure

Hi, I’m Dan Smith, Director of Operations at CatSci.

CatSci actively performs research and development on APIs with a potency defined by the Occupational Exposure Limits 0.1 – 1.0 µg/m3 (CatSci band OEB-5). Our focus is to develop reaction understanding through the design and optimisation of reactions on scales below 10 g with a maximum scale of non-GMP material supply of 10 g. Our SafeBridge-certified suite is equipped with a CTS powder handling isolator allowing effective containment and manipulation of solids within the isolator. Solution handling is conducted within an adjacent set of fumehoods, with direct ducting from isolator to fumehood. This capability is led by an internal specialist and employs a small team of chemists specifically trained to operate at this level of potency. Safety is always our highest priority and we have strict occupational hygiene control procedures in these laboratories to keep our team safe.

The suite is further equipped with a parallel reactor platform compatible with PAT to enable in depth reaction monitoring and further supported by safe access to on-site analytical techniques. For project specific needs, capabilities are deployed as needed to support our range of route design, process invention and characterisation projects.

Catalysis: Transcript

Green Chemistry

Hi, I am Vargini, an Associate Principal Scientist at CatSci.

Developing processes that take medicines to patients in need is the heart of everything we do at CatSci, and catalysis plays a pivotal role in developing efficient and green processes, giving us access to difficult transformations.

Our in-depth knowledge and experience in both bio- and chemo-catalysis allow us to systematically explore the reaction space and find the best catalyst for a chemical process. We have an extensive library of over 500 commercially available catalysts and ligands to support us with this process.

We are unbiased on which technology to use in our processes and are willing to screen all commercially available options, regardless of the IP owner, to ensure the best results for your process.

To efficiently screen atmospheric pressure reactions, we have refined workflows for 24, 48 and 96 parallel reactions with fast analytics for profiling. we have a bespoke glove box that allows up to 5 scientists to work simultaneously on air and moisture sensitive reactions. For pressurised reactions we have a specialist kit for screening 8, 48 and 96 parallel reactions.

The solutions identified at this phase are then developed into robust scalable processes by our team of experts.

Material Science: Transcript

Material Science

My name is Robert Dennehy, and I am Director of Material Sciences at CatSci. We are a team of experts in solid-state and crystallisation, all of whom have relevant PhDs and a track record in solving difficult problems. Some examples of problems that we have solved recently include the salt screening and assessment for a basic drug, where we applied a tiered approach to collecting physicochemical data, the baselining of a crystallisation of an NCE in Phase II clinical trials, which identified potential problems with solid state form control and process efficiency, and the understanding of a crystallisation of a cyclodextrin complex to address a problem of slow filtration.

We have a full range of crystallisation platforms and analytical equipment. For crystallisation, this ranges from screening platforms like the Crystal 16, where we measure solubility curves and metastable zone widths at small scales, to the Crystalline, where we can perform crystallisation at small scale with overhead agitation. We also possess jacketed lab reactors for larger scale process definition, and we can measure filtration rates and cake wash efficiency. Our analytical capabilities are comprehensive and recently purchased, and include the Aerus XRPD with variable temperature capability, the Mettler DSC and TG with sample autochangers, and the DVS Intrinsic for water sorption. We have two polarised light microscopes, one of which is fitted with a Linkham hot stage. We can also measure bulk density via tapping. Our PAT capability includes a Blaze probe for in-situ particle imaging and size measurement, and is Raman compatible.

For evaluating the developability of solid-state forms alongside comprehensive physical property testing, we have stability cabinets, as well as the Pion Rainbow system for measuring biorelevant dissolution.

We believe in an active dialogue with the client to understand their problem and always keep the needs of the formulation at the forefront when finding solutions. We have a dedicated focus on sound science, and do not believe in guesswork or intuition.

Analytical: Transcript

Essential Expertise

Hi, I’m Beth, the Analytical Group Leader at CatSci.

At CatSci, we understand the importance of getting analytical chemistry right. Our expert analysts have over 20+ years’ experience in analytical science with significant GMP experience in large pharma. They possess in-depth expertise in LC method development, LC-MS, GC-MS, NMR and in standard analytical techniques. We exploit the latest digital tools, using in-silico predictive modelling and an AMQbD approach for the method development lifecycle.

We recognise that reaction and process understanding requires a close collaboration between chemistry and analytical functions, and also for ensuring process safety. We assign an analytical project lead within each cross-functional project team who are accountable for the delivery of the project’s analytical needs, as well as working closely with the customer to ensure we continue to meet their requirements.

Our laboratories have walk-up LC-MS instruments, and our chemists are fully trained to run their own samples and interpret data to give them access to faster information.

This reduces experimental turnaround time and frees up the hands and minds of our analysts to work on more complex problem-solving. We understand and mitigate method failure through risk assessment and structured experimentation.

We have two dedicated analytical science laboratories - one at our headquarters in Cardiff and also our new facility in Dagenham, which is fully equipped with state-of-the-art analytical equipment, through a collaboration with Shimadzu Corporation, providing the highest-quality analytical data and critical interpretation to our customers.

Our capabilities allow us to perform data-driven process development and QC testing of drug substances plus provide support to our material science and oligonucleotide teams.

Oligos: Transcript

Oligos

Hi, let me introduce myself; I am Dr Nigel Richardson, CatSci’s Director of New Modalities. New Modalities include oligonucleotides. This is an exciting and very innovative area of science that offers new therapeutic opportunities to treat previously unmet patient needs.

Oligos are a type of RNA Therapeutic, where a small synthetic strand of modified RNA can act to inhibit protein formation. This is a complex area of science, with challenges in the optimisation of the solid phase synthesis to control the impurities and deliver material to the appropriate quality standard. There are also challenges in the analytical characterisation of these large, complex molecules. Our oligo team and our new dedicated laboratory is fitted with state-of-the-art equipment to meet these challenges. We can synthesise oligos from nanomole quantity to support cell-based assay screens, to 30g of material for toxicological investigation or impurity reference markers. These materials we make can be fully characterised by the dedicated high resolution HPLC Mass Spec equipment.

The team has expertise in CMC and regulatory requirements for oligo therapeutics. We have experience in process robustness studies that support late-phase development. We are very excited by our new capability that will help deliver new medicines to the waiting patients.

Transcript

Partnering with CatSci

I hope you’ve enjoyed the chance to see a little bit of who we are and what we do. But most importantly why we do it. Across the company, we are relentlessly driven by our purpose to get new medicines into the hands of patients in need, and this has been widely recognised over the years – most notably by our recent Queen’s Award for Enterprise.

Our ambition is to play an even more impactful role in the future, and to become a partner of choice for pharmaceutical innovation. So, we continue to invest in new capabilities that are of value to our customers, for example, material science, high potency and, most recently, oligonucleotides.

We are building an integrated offering to support the research, development and manufacturing of drug substance and drug product in the small molecule and new modalities space.

If you would like to explore how CatSci might be a good fit to work with you to deliver important new therapeutic programmes for patients, please get in touch. We would love to hear from you.