Arcinova strengthens API services with new GMP manufacturing capabilities
Arcinova has made a major investment in its Active Pharmaceutical Ingredient (API) capabilities.
We are pleased to announce that we have introduced two new 20-litre GMP vessel streams to our 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 the addition of 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 L of cumulative reactor volume at their Alnwick site. This will now enable Arcinova 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 incorporating CFR21 and GAMP 5 compliant data logging and can operate between 180 °C and minus 80 °C. They use active data logging of vessel temperature and stirring rates in a fully CFR21-compliant system.
The streams operate in conjunction with a contained Nutche filter for API isolation, and a 0.15128 litre sqm vacuum oven for the drying of intermediates. Arcinova also offers a dedicated raw material and final product storage and sampling facility.
Arcinova have 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 our drug substance manufacturing capacity.
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 is able to offer 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.”