Arcinova Strengthens Its API GMP Manufacturing
The company has introduced two new GMP vessel streams at its API manufacturing facility in Northumberland, UK that allows it to now offer fully integrated drug substance and drug product manufacturing.
On Nov. 10, 2017, Arcinova, a multi-service contract resesearch and development organization, introduced two new 20-liter GMP vessel streams at its active pharmaceutical ingredient (API) manufacturing facility Alnwick, Northumberland, UK. The addition of the two new streams gives the company the ability to offer fully integrated drug substance and drug product capabilities in one site.
With the two new 20-litercapacity GMP streams and one five-liter GMP stream installed earlier in 2017, the new systems give Arcinova over 140-liters of cumulative reactor volume at their Alnwick site. The company now has the capability to produce between 0.5 g to 4 kg of API or an intermediate per batch, giving it an annual total capacity of approximately 500 kg.
The vessel streams are housed in a fully GMP-compliant facility and can operate between 180° C and -80° C and use active data logging of vessel temperature, pressure, and stirring rates. They operate with a contained Nutche filter for API isolation and a 128-liter vacuum oven for drying intermediates.
The company has also further invested in Flowsyn flow equipment to enhance its API GMP manufacturing capabilities and will continue to invest in flexible modular manufacture technology to increase its drug substance manufacturing capacity.
The company’s services encompass drug substance synthesis, drug product manufacture, chemistry, manufacturing and controls, bioanalytical and metabolism services, radiolabelling synthesis, and synthesis of toxic/highly potent APIs.
Source: Arcinova
