Laureate Pharma Secures $20 Million to Grow Biopharmaceutical Contract Manufacturing Business

Laureate Pharma, Inc. (Princeton, NJ) has secured $20 million in debt and equity financing to grow its business. The new funds will be used to expand existing capacity in protein production and aseptic filling and to expand its service offerings in analytical testing and cell line development.

Planned projects include upgrading aseptic fill capabilities through the construction of a new segregated fill suite and the installation of a fully automated fill line incorporating vial washing, depyrogenation, filling, and capping. All product contact pathways of the new line will be single-use. Commissioning is planned for early 2012.

The company will upgrade protein production services to increase bioreactor (2,000-L) and purification (10-L chromatography skid) capacity, install new gowning rooms, and renovate purification suites.

A contract analytical testing business will be launched to serve a broader client base including clients who do not require other Laureate services. Laureate will enhance sample management procedures, and upgrade and add new instrumentation to offer a full range of testing required to characterize protein products.

Laureate will expand its 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.

New quality systems technologies will be adopted, including systems to manage inventory, deviations, and calibration and validation. In addition, the company will acquire new software 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.