Alnwick, UK-headquartered Arcinova, which provides both end-to-end solutions and standalone services to pharmaceutical and biotech companies, has introduced two new 20-liter GMP vessel streams to its active pharmaceutical ingredient (API) manufacturing facility.

Arcinova can now offer fully integrated drug substance and drug product capabilities on one site. With two 20-liter capacity GMP streams and one five liter GMP stream, which was installed earlier in 2017, the new systems afford Arcinova over 140-liters 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-liter 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 says it will continue to invest in flexible modular manufacture technology to increase its drug substance manufacturing capacity.

“The introduction of the 20 liter streams forms part of our business growth strategy and will enable us to further enhance the service Arcinova offers our global customer base,” said Paul Quigley, head of API development and bioanalytical services, Arcinova. “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, Arcinova, said, “The installation of the new 20 liter 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 February 2016, Arcinova operates from a 15,000-square meter facility on a 34-acre site, which has benefited from decades of investment as a key research and development center for Sanofi and Covance, allowing it to offer a rare range of on-site capabilities as a contract research and development (CRDO).