The clinical and commercial success of biotherapeutics hinges on the development of robust, reproducible and scalable processes that yield active product, at an attractive cost and enable rapid transfer to cGMP manufacturing.

Mammalian Cell Culture & Microbial Fermentation

Our cell culture and fermentation groups emphasize the application of scientific excellence to process development. In addition to mammalian and bacterial cell lines, we also have broad experience with yeast and insect cell lines.

We maximize the design of our laboratories, systems and equipment, as well as our operating procedures, to avoid delays and streamline process development, clinical manufacturing and technology transfer.

Service offerings include:

• Selection of clones (productivity, stability)
• Cell line evaluation
• Cell line adaptation (e.g. to serum-free or suspension culture)
• Medium development (animal component free)
• Development of reproducible, robust and scalable processes
• Development of nutrient feed strategies to prolong culture life and production
• Optimization of existing processes
• Identification of critical process parameters
• Development of process control strategies
• Production at pilot scale for preclinical studies
• Process cost analysis
  

Purification

We provide high yields of clinically active proteins to the quality standards necessary for use in human clinical trials. Considerable attention is paid to viral inactivation/clearance steps for products derived from mammalian cell culture. Our scientists and engineers are industry leaders in this field and apply the company's expertise in analytical and biophysical characterization to efficiently design robust and economic processes, which maintain biological activity and stability of the selected purified products.

• Development of recovery and harvest processes
• Development of robust and scalable chromatographic processes
• Development of various separation processes
• Optimization of existing processes
• Identification of critical process parameters
• Development of process control strategies
• Production at pilot scale for preclinical studies
• Development of viral clearance unit operations
• Execution of viral clearance studies (with third party vendors)