July 1, 2008
The biopharmaceutical industry is faced with a challenging task: planning, developing, manufacturing, and bringing to market a highly specialized and complex biopharmaceutical product. Competitive pressures, cost, and — above all — time to market are of key concern.
The wide range of implementation options, from in-house resources to outsourcing companies of various calibers and capabilities, adds yet another layer of complexity to the decision-making process. Our objective is to offer our customers a full-service alternative to the development and manufacturing portions of this process. We offer a proven, fully integrated facility staffed with skilled professionals in each critical area. Our management and staff combine years of experience and capabilities in manufacturing both clinical-trial and commercial biopharmaceuticals.
Although some of our capacities and capabilities are comparable with other contract services, it is our unique focus on and experience with products expressed by mammalian cells that set us apart. It is this combination of expertise and available production capacity that offers both biotech and pharmaceutical companies an ideal opportunity to take advantage of our contract service programs.
The first critical step in the development phase of biopharmaceuticals — cell line optimization — should be entrusted to a highly experienced protein product development team. Our cell culture and molecular biology technicians have the experience to improve and maximize cell line productivity in optimal media for downstream processing.
Laureate Pharma can also complement your own process development staff with expertise and experience in bringing protein-based parenterals from lab scale to pilot scale and commercial production. Development of robust, well-integrated, and high-yielding processes is a vital step before proceeding to cGMP production. We offer appropriate equipment for affordable production. Our 57,000-ft2 facilities in Princeton, NJ, house stirred-tank, hollow-fiber, and Wave bioreactors with capacities from 20 L to 2,000 L (Vw). Critical equipment and processes have been validated for the production of biopharmaceuticals and are periodically inspected by regulatory agencies.
From sample preparation to initial capture to polishing and final product formulation, we offer more than just the standard methods of purification at scale. We have experience in performing conjugation for clinical and commercial products and the special expertise in working with conjugation of chelators to proteins for radiolabeling.
Our quality systems consist of quality control, quality assurance, microbiology, and validation. The integration of all these groups ensures compliance at every step of the manufacturing process. We offer analytical and microbiology testing for raw materials and in-process and finished protein, antibody, and pharmaceutical products. Our labs are registered with the FDA and licensed by the DEA and NRC. Our facility has a modern aseptic filling room that can accommodate 2–100 mL vials with 0.1–100 mL fill volumes. Our current equipment can process batch sizes up to 20,000 vials or 200-L in bulk volume. We invite you to discuss your needs with our development team as early in your planning stage as possible.
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