Laureate Pharma, Inc., a full-service contract development and manufacturing organization 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.
Laureate Pharma has added 10 new jobs since bringing on a
new CEO and a new Vice President of Business Development and plans to fill 50
more positions when working at capacity.
