The facility in Santa Ana, California has increased its dedicated capacity for Irvine Scientific’s animal component free (ACF) dry powder, used in the cGMp production of biologics, vaccines and cell therapies, to 12,000L through the expansion.
While financial details were not divulged, spokeswoman Lori Serles told Biopharma-Reporter the expansion is continual and linked to the firm’s long-term growth strategy.
She added the expansion was necessary to feed demand for the number of biopharmaceuticals in development.
“Every market report shows an expected increase in the production of biotherapeutics, both in quantity and in number of approved drugs. Coupled with that is a projected increase in demand from existing customers and new customers as our account base expands.”
The new tumble blending enables the company to provide customers with homogeneous powder media in single production batch sizes of up to 7,000 kg.
“As more companies learn of our capabilities and the quality of our products the demand for our media keeps increasing. We are very confident that we will be making full use of our expanded production capacities.”
The expansion will not lead to new hirings, per se, though Serles said the firm has been growing in headcount in recent years though and expects that trend to continue.
ACF powder media
Irvine’s manufacturing process follows regulatory guidelines for current good manufacturing practice (cGMP).
“In very simplistic terms the components, or qualified raw materials, of our media are processed in an impact mill, then blended in our tumble blender to achieve a dry powder media that is homogeneous for consistent particle size as well as uniform distribution of components,” Serles explained.
“Formulas, processes and material transfer are all designed and optimized to minimize the potential of contamination, thermal damage or de-blending of media that other processes such as mechanical conveyance can have.”