Arcinova strengthens API services with new GMP manufacturing capabilities
Multi-service Contract Research and Development Organisation Arcinova has made a major investment in its Active Pharmaceutical Ingredient (API) capabilities.
Alnwick, UK-headquartered Arcinova, which provides both end to end solutions and standalone services to pharmaceutical and biotech companies, has announced that it has introduced two new 20-litre GMP vessel streams to its API manufacturing facility.
The introduction of the two new streams means that Arcinova can now offer fully integrated drug substance and drug product capabilities on one site.
With two 20-litre capacity GMP streams and one five litre GMP stream, which was installed earlier in 2017, the new systems afford Arcinova over 140-litres of cumulative reactor volume at their Alnwick site. Arcinova are now able to produce between 0.5g to 4kg of API or an intermediate per batch with an annual total capacity of min. 500kg. The vessel streams are in a fully GMP-compliant facility and can operate between 180 °C and -80 °C. They use active data logging of vessel temperature, pressure and stirring rates in a fully CFR21 compliant system.
The streams operate with a contained Nutche filter for API isolation and a 128-litre vacuum oven for the drying of intermediates. Arcinova also offers a dedicated raw material and final product storage and sampling facility.
Arcinova has further invested in Flowsyn flow equipment to enhance the capability of these assets and will continue to invest in flexible modular manufacture technology to increase its drug substance manufacturing capacity.
Arcinova works across drug substance synthesis, drug product manufacture, Chemistry, Manufacturing and Controls (CMC), Bioanalytical and Metabolism services, radiolabelling synthesis and synthesis of toxic/highly potent APIs. It also provides consultancy services and works in partnership with companies throughout the drug development process.
Paul Quigley, Head Of API Development and Bioanalytical Services, said: “The introduction of the 20 litre streams forms part of our business growth strategy and will enable us to further enhance the service Arcinova offers our global customer base.
“Our ability to offer fully integrated drug substance and drug product capabilities on one site, is a major advantage for our customers and allows us to react more quickly and nimbly to client requirements, and provide security of supply.”
Ian Shott, Managing Director of Arcinova, added: “The installation of the new 20 litre streams at our Alnwick site is part of a program of continued investment in our capabilities.
“Since the company was launched in 2016, we have built on the world class facilities of the site, and the legacy of its former owners, Covance and the growth of our API department is a key part of this.”
Launched in 2016, Arcinova operates from a 15,000 m2 facility on a 34-acre site, which has benefited from decades of investment as a key research and development centre for Sanofi and Covance, allowing it to offer a rare range of on-site capabilities as a CRDO.
Arcinova’s senior scientific team are renowned for their world class, specialist research and development expertise and their big pharma and CRDO experience gives them extensive, broad ranging industry knowledge and insight.
Arcinova works with big pharma, specialty pharma and biotech companies across the globe, from established multinationals to emerging start-ups.
For more information on Arcinova, click here.
The introduction of the two new streams means that Arcinova can now offer fully integrated drug substance and drug product capabilities on one site