Full Scope of New Service Capabilities to be Operational in Q2; Company Has Already Secured Project Commitments from Multiple New Clients
San Diego, CA and Gainesville, GA — Recro Pharma, Inc. (“Recro”; NASDAQ: REPH), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today 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, chief executive officer 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 state-of-the-art water for injection system.
About Recro Recro (NASDAQ: REPH) is a bi-coastal contract development and manufacturing organization (CDMO) with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Recro is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market.
In addition to our experience in handling DEA controlled substances and developing and manufacturing modified-release dosage forms, Recro has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California.
For more information about Recro’s CDMO solutions, visit recrocdmo.com.
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