Onyx Scientific is a Contract Development and Manufacturing Organization (CDMO) that specializes in process R&D, non-GMP scale-up, and GMP manufacture for clinical trials and commercial applications.
With facilities in the UK and US, their dedicated teams in chemistry, solid-state and analytical chemistry guide small molecule Active Pharmaceutical Ingredient (API) products through development and manufacturing.
In anticipation of CDMO Live, we had a conversation with Chris Atherton, the Commercial Manager of Onyx Scientific, who shed light on their business operations.
24 years of growth
“Onyx was one of the first chemistry CDMOs to invest in solid-state, and we plan to continue investing in this area in the future.” says Chris.
Established in 2000, Onyx Scientific has garnered 24 years of successful experience within the preclinical development space, completing thousands of development projects. Their pragmatic ‘fit for purpose’ approach is centred on intelligent rapid process development with an eye towards future GMP campaigns.
Over the years, Onyx has experienced organic growth. From an initial team of seven founders, they now boast over 110-120 employees across two sites in Sunderland.
They have invested in a new facility in Sunderland, just five minutes from their original site. This has allowed them to significantly invest in their non-GMP scale-up and GMP services, increasing capacity in both areas. They also have plans for the acquisition of additional state-of-the-art equipment in the very near future.
Despite this growth, “Onyx have maintained a small to medium-sized company mentality, which allows us to remain flexible and reactive to customers’ needs.” says Chris.
Chemistry at the heart of operations
“A common question posed by customers is, ‘how do you manage to accomplish so much?’” says Chris.
The answer lies in their expert teams within the analytical, solid-state, operations, and quality departments who support their chemists, who are at the core of everything they do.
“This approach allows our chemists to fully utilise their skills and execute projects without distractions, resulting in increased productivity across all projects.” he says.
Onyx’s solid-state services run as an integrated extension of chemistry and analytical departments, always keeping the end goal in mind. This goal is a robust understanding of physiochemical properties and control of the critical quality attributes of the molecule, enabling and de-risking synthesis at scale.
“Our integrated approach allows us to use solid form development to aid our chemistry teams when faced with difficult purification of process intermediates. This has enabled us to complete some extremely challenging development campaigns in an accelerated manner, keeping projects on track where a more standard approach may have become protracted.” says Chris.
Sustainability initiatives
Sustainability is becoming an increasingly important consideration in the pharma industry, but it presents several challenges for drug manufacturers. Balancing economic considerations with sustainability goals is a complex task that should not be underestimated.
“Over the last two years, Onyx has created short and long-term sustainability initiatives that are achievable and continuous. These include incorporating green chemistry practices into our process development and optimization to maximize yields. We’re also focusing on minimising our environmental impact by consolidating raw material deliveries to reduce our carbon footprint and implementing smart sensors to lower energy consumption, as well as reducing water consumption by implementing dry condenser technology.” says Chris.
Historically, the industry has been very paper-heavy. Onyx is moving towards a paperless approach wherever possible and is engaging in local environmental initiatives.
Setting the right expectations
Selecting the right contract service provider is a crucial step in the overall success of a GMP API manufacturing project and partnership. A compatible cultural fit between the company and the CDMO of choice is vital.
Two-thirds of Onyx’s customers highlighted the importance of setting explicit expectations early in any partner relationship as key to project success.
“Biotech and pharma companies should expect the CDMO to add value from the outset, at the request for quotation stage, even before any work starts.” says Chris.
“CDMOs need to really understand the project requirements. During these discussions, the CDMO should take a consultative role, suggesting alternative strategies and using their knowledge to add value to the process.”
“Crucial questions that biotechs and pharma should be asking include:
- Will the CDMO give you access to the whole team, including direct access to the chemists who understand your molecule?
- How does the CDMO deal with failure and handle problems early on in the relationship?”
To find out more about Onyx Scientific, join them at CDMO Live 2024
