Onyx Scientific makes strategic investment in commercial API licence
Investment fills the growing gap in the market for manufacturers that have the niche capabilities to deliver small-scale commercial API projects.
Onyx Scientific has made a strategic investment to position the company for a commercial API licence. Driven by growing demand for flexible, specialist and small-scale API manufacture, the investment will see Onyx expand its UK facility, putting in place the infrastructure to take customers’ projects from concept right the way through to commercialisation.
As part of the initiative, Onyx will invest in implementing Quality by Design (QbD) and Design of Experiments (DoE) principles into its API development and manufacturing practices, establishing critical quality parameters for every product. The company will also expand its team of scientists, as well as its analytical and quality assurance (QA) teams.
Onyx has engaged with the Medicines and Healthcare Products Regulatory Agency (MHRA) from the initial stages of its move to commercial manufacture. Following the licence approval, which is expected later this year, the UK facility will have the capacity to manufacture low volumes of drug substance, particularly for orphan drugs. This new service will complement the company's facilities in North Carolina and India, which offer larger scale manufacturing capability.
Denise Bowser, commercial director at Onyx Scientific, said: “Onyx has built a great reputation in the market for helping drug developers to deal with complex chemistry and deliver early-stage programs that enable them to progress their candidates. It’s an important milestone in the growth for our UK facility to be able to support customers in taking projects through to full commercialisation.
“There is a growing gap in the market for manufacturers that have the niche capabilities to deliver small-scale commercial API projects. We want to fill that space and remove the need for our customers to seek other partners to help them manufacture their drug substance commercially. With our commercial licence in place we can respond to customers’ growing requirements for quick set-up and fast turnaround of products on a bespoke basis.”
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance