Oct 7 2010
Laureate Pharma, Inc., a full-service contract development and manufacturing organization today announced that it has secured $20 million in debt and equity financing to enhance and grow its business.
Building on nearly 30 years of experience in the development and supply of protein drug products produced from mammalian cell culture, Laureate Pharma will be able to better serve its clients by accelerating their timelines from development through production.
"Today marks a significant milestone in our efforts to relaunch Laureate Pharma," said Michael A. Griffith, Chief Executive Officer. "Our strategically planned improvements coupled with our solid financial footing will position us for exceptional growth."
Mr. Griffith continued, "As we transform Laureate, care will be taken to maintain continuity of client services. Quality Assurance will oversee investment activities to ensure our offerings comply with the strict demands of global regulatory agencies."
The new funds will be used to drive five investment initiatives over a three-year period and will provide a more robust portfolio of services to better serve customers' needs and include:
- Upgrading aseptic fill capabilities through the construction of a new segregated fill suite and the installation of a new fully-automated fill line incorporating vial washing, depyrogenation, filling, and capping. All product contact pathways of the new line will be single-use disposable. Commissioning is planned for early 2012.
- Upgrading protein production services to increase bioreactor (2000L) and purification (10L chromatography skid) capacity, new gowning rooms, renovated purification suites and additional support utilities.
- Launching a contract analytical testing business to serve a broader client base including clients who do not require other Laureate services. Laureate will enhance sample management procedures, upgrade and add new instrumentation to offer a full range of testing required to characterize protein products.
- Expanding mammalian cell line creation services; in 2011, Laureate will offer access to a variety of protein expression systems that can be selected based on the specific characteristics and requirements of the protein product. Additionally, the Company plans to add cGMP cell banking services.
- Adopting new quality systems technologies including new systems to manage inventory, deviations, and calibration and validation. In addition, the Company will acquire a new software solution that will enable it to assemble documentation for clients in an eCTD format. Finally, Laureate will expand its regulatory affairs unit to assist clients in the preparation of data summaries, batch reports and regulatory submissions.