Upstream Processing

At Laureate we provide superior contract manufacturing services that accelerate new products from development through production.

Cell Line Optimization
Our highly experienced cell line development team at Laureate ensures that this first critical step in the development phase of your biopharmaceutical is improved. We strive to maximize the yield of cell line productivity in optimal growth media. We can offer a full range of services including the following:

• Create and select high producing stable cell lines from DNA transfection with your favorite cell lines and expression system
  
• Optimize/improve your existing stable cell line for production
  
• Adapt cell lines to serum free and suspension culture
  
• Develop and optimize cell growth medium
  
• Evaluate cell line stability and production suitability
  
• Prepare/coordinate the master cell bank and working cell bank production and external safety characterization

Cell Culture Process Development
Cell culture process development is a vital step in large-scale production. We have the expertise and experience in bringing protein-based parenterals from lab scale to pilot scale and all the way to commercial production. Our process development team conducts shaker flask, Wave bioreactor®, small and pilot-scale stir-tank bioreactor culture process development, including bioreactor parameter optimization, cell expansion in seed train, fed-batch strategy optimization and cell culture. Our team has extensive experience working with varied and robust protein production processes with most cell lines used for manufacturing, including CHO, NS0, BHK, SP2/0 as well as hybridomas.

Bioreactor Production
Our 57,000 sq.ft. modern facility at Princeton, New Jersey, includes development laboratories and manufacturing areas that house single-use disposable and stirred-tank bioreactors. The sizes of multiple stirred tank bioreactors range from 2L to 2,500 L and the Wave bioreactor® includes System 20 all the way to System 1,000. For clients who prefer perfusion process we also offer hollow fiber bioreactor services.

We routinely operate our bioreactors in batch/Fed batch modes. Our production taff has extensive experience doing tech transfers of clients' process to our facility. We can also develop the manufacturing process at Laureate for your target. Based on the clients' needs we can perform pilot runs engineering runs and GMP production runs. Our very experienced staff in the production group has produced protein-based biotherapeutics from Phase I all the way to commercial scale. We validate critical equipment and processes for the production of biopharmaceuticals, and our facility is FDA registered.