Welcome to the new Laureate Pharma. It is a busy time here as our company has reached a significant milestone, one which will serve to accelerate your timelines from development through production.
We have secured $20 million in capital, which will be used for strategically-planned improvements to our client offerings by creating a new testing unit, enhancing our scientific expertise, adding to our process development toolbox and enabling Laureate to expand cGMP production capacity.
These improvements, coupled with our solid financial footing and our nearly 30 years experience in the development and supply of protein drug products produced from mammalian cell culture, will position us for exceptional growth.
Our capitalization will be used to drive several initiatives, over a three-year period, and will allow for a more robust portfolio of services including:
- 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.
- Upgrading protein production services to increase bioreactor (2000L) and purification (10L chromatography skid) capacity, build new gowning rooms, renovate purification suites and add 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.
As we transform Laureate, care will be taken to assure continuation of all client services during phases requiring construction. Quality assurance will ensure our offerings comply with the strict demands of global regulatory agencies.
I encourage you to check back often for updates. We look forward to sharing more good news with you as our capitalization milestones are achieved and as we continue to accelerate your journey from development through to production.
Michael A. Griffith, Chief Executive Officer
