Recro Pharma Inc. has reported key progress in adding fill/finish and lyophilization capabilities to its broad suite of CDMO offerings.
 
All construction and equipment installation related to this service expansion has been completed at the company’s San Diego facility and final validation and commissioning activities are underway.
 
The company expects that its new automated fill/finish line and lyophilization unit will be operational early in the second quarter. Recro has already secured agreements for customer projects involving these new capabilities and continues to work to book additional business for fill/finish and lyophilization projects.
 
“Our expansion into the areas of fill/finish and lyophilization represents a critical element of ongoing strategic efforts to establish Recro as an end-to-end provider capable of addressing all of the CDMO service needs of our customers. Importantly, this service expansion will unlock key additional revenue sources for the company and we are excited to report that we have already pre-booked several customer projects focused on utilizing these new capabilities,” said David Enloe, CEO of Recro. “We are on schedule for the launch of both of these new services in the second quarter and look forward to efficiently completing the remaining validation and commissioning activities. I would like to recognize our technical and engineering teams for the diligence and commitment to getting these services online for our clients.”
 
The company’s aseptic fill/finish suite will feature a sterile, automated vial filling system with the capability to fill up to 2,000 presterilized vials per hour at a range of volumes. The lyophilization offering incorporates a novel, patented approach to uniformity and instantaneously induces nucleation via pressurization and depressurization. This equipment provides the capacity for lyophilization of approximately 9,000 10 mL vials during each 3-5 day freeze-drying cycle.
 
Both the filler and the lyophilization equipment were supplied by SP Industries, a U.S.-based designer and manufacturer of specialty laboratory equipment, and its Barcelona-based subsidiary i-Dositecno. To support these new services, Recro has also invested in a U.S.-based water for injection system.