Recro Reports Progress Towards Launching Fill/Finish and Lyophilization Capabilities at San Diego Facility
Recro Pharma has announced significant advancements in its contract development and manufacturing (CDMO) capabilities, including new fill/finish and lyophilization services. Construction and equipment installation at their San Diego facility are complete, with operations expected to commence in Q2 2022. The company has secured commitments from multiple clients for projects utilizing these new capabilities, which will enhance revenue opportunities. The aseptic filling can process 2,000 vials/hour, while the lyophilization unit can handle 9,000 vials every 3-5 days. Recro aims to be an end-to-end service provider for customers.
- Expansion into fill/finish and lyophilization services expected to unlock additional revenue sources.
- Multiple customer agreements pre-booked for new capabilities, indicating strong demand.
- Completion of construction and installation of new services ahead of Q2 operational target.
- None.
Full Scope of New Service Capabilities to be Operational in Q2; Company Has Already Secured Project Commitments from Multiple New Clients
SAN DIEGO, Calif. and GAINESVILLE, Ga., Feb. 23, 2022 (GLOBE NEWSWIRE) -- 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.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements, among other things, relate to the Company’s ability to manage costs and to achieve its financial goals; to operate under increased leverage and associated lending covenants; to pay its debt under its credit agreement and to maintain relationships with CDMO commercial partners and develop additional commercial partnerships; and to expand its capabilities. The words “anticipate”, “believe”, “could”, “estimate”, “upcoming”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “will” and similar terms and phrases may be used to identify forward-looking statements in this press release. Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. Factors that could cause the company’s actual outcomes to differ materially from those expressed in or underlying these forward-looking statements include risks and uncertainties associated with the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the customer ordering patterns or inventory rebalancing or disruption in raw materials or supply chain; demand for the company’s services, which depends in part on customers’ research and development and the clinical plans and market success of their products; customers’ changing inventory requirements and manufacturing plans; customers and prospective customers decisions to move forward with the company’s manufacturing services; the average profitability, or mix, of the products the company manufactures; the company’s ability to enhance existing or introduce new services in a timely manner; fluctuations in the costs, availability, and suitability of the components of the products the company manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials, or the company’s customers facing increasing or new competition. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results presented herein along with those risks and uncertainties discussed in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.
FAQ
What new capabilities has Recro Pharma added as of February 2022?
When will Recro Pharma's new services be operational?
What is the expected capacity of Recro Pharma's new aseptic fill/finish line?
How many vials can Recro Pharma's lyophilization unit process?
What is the significance of Recro Pharma's service expansion for its revenue?
