About Onyx Scientific
Onyx Scientific is the Contract Development and Manufacturing Organization (CDMO) division of Ipca Laboratories.
Onyx Scientific offer small molecule drug substance development and manufacturing services. MHRA-licensed sites in the UK offer early development of candidate APIs and manufacturing for clinical phases through to commercial supply.
Onyx have dedicated solid-state and analytical chemistry teams who are able to expedite development activities but are also available to provide full-service outsourced projects to complement or support to customers in-house campaigns.
Formed in 2000, Onyx boasts 24 years of early development experience and success. Onyx is a small to medium sized company, employing around 120 staff over two sites in Sunderland. Their pragmatic, fit-for-purpose approach focuses on rapid process development and a view to future GMP campaigns. Where required, scale-up through Phase II towards commercial manufacture is retained either at Onyx, for low volume requirements, or within the Group through transfer to sister sites in the USA and India.
Onyx adopts a consultative and collaborative approach to always give customers direct access to the project team. Development projects are run in a way that allows the technical experts freedom to work without distraction. Onyx integrates its solid state service with chemistry and analytical, with the end goal being the control of the physical properties of a drug substance whilst achieving API synthesis on a larger scale.
Onyx offer comprehensive and integrated CMC chemistry tailored to the exact needs of customers. As a result, the need to be flexible and reactive is paramount, which is where Metrohm comes in.
Q&A with Curtis Swift (Analytical Team Leader)
What is produced? Pharmaceutical drug substance (small molecule)
Major quality parameters? GMP
Parameters Controlled? Final product specification, intermediate analysis and
in-process controls
Where does the Control take place? GMP manufacture / QC / QA
How many people working in the lab? 40 over two sites in analytical, total employee count 110-120
Which parameters are determined with Metrohm Instrumentation? Water content, pH, conductivity, auto titrations
What specific challenges you face in monitoring these parameters? Side reactions between our analytes and the KF reagents are quite common. Sample dissolution is also a problem for a lot of the API’s/Intermediates we work with.
Why have you chosen a Metrohm system? The Metrohm system gave us the versatility we required, and we considered the price to be very competitive. The level of support received during design was great and the aftercare support is also very good. We regularly contact the Metrohm support via email and always receive a prompt reply with helpful suggestions.
How long have you been using Metrohm equipment? 5 years
What are the particular benefits of using this system? Data integrity on this system is much better with sample results and audit trails very straightforward to access for our system admins.
How is Metrohm after sales service and support? Excellent, we regularly contact the Metrohm support via email and always receive a prompt reply with helpful suggestions. I’ve even had help setting up a potentiometric titration method via Microsoft Teams with Metrohm which saved lots of time.
Why would you recommend Metrohm? Very good sales service, instrument service and support
Can you describe a specific instance where Metrohm instrumentation helped you overcome a particularly challenging analytical problem? Not yet but we are looking at extending our OMNIS platforms to add a KF oven which we are hoping will help us with the side reactions we are observing with some of our analytes.
How has the use of Metrohm instrumentation impacted the efficiency and accuracy of your laboratory operations? Improved the quality of documentation and sample throughput
Can you share any specific examples of benefits from the implementation of Metrohm solutions? We find that sample throughput has been much quicker compared to our other KF systems. This has been particularly noticeable in method validation which involves us running a higher volume of samples compared to routine analysis.