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Laureate Pharma, a full service contract manufacturing company located in Princeton, New Jersey, provides specialized services from process design and development to full-scale current Good Manufacturing Practices (cGMP) production, purification, aseptic filling, testing, validation, analytical services and regulatory support. Our experienced scientists purify biopharmaceutical proteins, expressed in mammalian cells, using state-of-the-art semi-automated chromatography systems and fill into vials under stringent aseptic conditions. Our contract manufacturing expertise spans the area of clinical to commercial-scale production of monoclonal antibodies, interleukins, enzymes, antibody conjugates and radiolabeled antibodies.
Laureate Pharma offers a proven, fully integrated cGMP facility staffed with experts and specialists in each critical area. The management and staff combine the unique experience and capabilities of manufacturing both clinical-trial and commercial scale biopharmaceuticals for over 20 years. We have a proven track record of taking products through development and manufacturing to the market. We focus on two active segments of the biopharmaceutical industry: monoclonal antibodies and recombinant protein products.
Our 57,000 sq.ft. (5,300m2) facility in Princeton, New Jersey, includes development laboratories and manufacturing areas that house both hollow-fiber and stirred-tank bioreactors, ranging from 20 to 2,500L in size. Laureate Pharma’s assets include multiple stirred tanks, wave systems and hollow fiber bioreactors. We validate critical equipment and processes for the production of biopharmaceuticals, and the regulatory agencies routinely inspect our facilities.
We offer aseptic fill and finish services to formulate and fill the final product. Our facility features a specialized high precision filling machine with minimal holdup volume and whose product contact parts are all single use disposable. It operates within a class 100 filling area and can accommodate vials from 2-100 mL in size, with fill volumes from 0.1 - 100 mL. This equipment can accommodate batch sizes up to 20,000 vials or 200 liters of bulk volume. We perform Formulation development, QC testing, Media fills with product-specific components, Container-closure studies, SOPs and documentation systems and Full ISO environmental monitoring.
Our Quality System consists of Quality Control (QC), Quality Assurance (QA), Microbiology and Validation. The integration of all these functional operations ensures compliance at every step of the cGMP and manufacturing process. The Quality System department works closely with manufacturing groups to assure adherence to quality standards in all systems and processes throughout Laureate Pharma’s facilities.
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