Process Development

CUSP process development capabilities include downstream recovery and purification (biological macromolecules) and a wide range of finished product manufacture (small molecules, peptides, and macromolecules). Experience in the areas of lyophilization and sterile product manufacture are especially extensive.

CUSP helps plan and implement many aspects of process development-

  1. Process design: Screening, selection, staging and optimization of unit operations for manufacturing processes

  2. Process development, downstream (biological macromolecules): product recovery via precipitation, filtration, centrifugation, and chromatography

  3. Finished product manufacturing (sterile product manufacture): Identification of appropriate approaches for producing sterile product

  4. Formulation: Mixing of drug substance, excipients and solvent according to batch recipe

  5. Filling: Transfer of bulk drug product solution to individual dosage units

  6. Freeze drying: Removal of water to increase product stability. Optimization of freezing function, primary and secondary drying

  7. Technology transfer to manufacturing (GMP): Scale-up and adjustment of laboratory and pilot scale processes to match requirements of the manufacturing environment