Dispatches from AAPS
Kemwell announces Cirrus to produce trial supplies in 'flexi suite'
At the AAPS (American Association of Pharmaceutical Scientists) Annual Meeting in San Diego yesterday, Ninad Deshpanday, President of R&D at Kemwell, told Outsourcing-Pharma.com CDMO Cirrus is set to expand its services from R&D-only to manufacture.
Construction of the flexible GMP room is due to finish in April next year and will manufacture “all types of formulation except sterile products.”
“I’m calling it a flexi suite – what’s so exciting is it’s not only for aerosols or solids. We’re designing it so we can roll in and out equipment in using steel carts on rollers, depending on the dosage form,” said Deshpanday.
The company will use mostly equipment it already owns for formulation development, meaning funds are only being spent on building a clean room and decking it out with air and water filters, electrical connections and gowns. Cirrus will staff the unit with four employees: two process development workers who will be trained in manufacturing, and a QA head and a facilities manager.
Manufacturing capacity will be for early stage trials only, at a volume of one to 25 litres. “We won’t be able to support a Phase III 2,000-patient clinical from here. That’s when we’ll transfer to Bangalore, where our larger CMO facilities will help.”
Kemwell bought Cirrus in August last year, when it developed only aerosol products. Since then, the North Carolina company has expanded to perform contract development for oral products and peptides and proteins.
The Indian company has made a series of investments in recent months to its Bangalore facilities, including an oral solid dose manufacturing plant, and a commercial-scale lyophilisation unit.