Process Development

LSNE Contract Manufacturing offers a full range of process development services in our cGMP facility located in Bedford, New Hampshire.  Utilizing data from our freeze drying microscope and differential scanning calorimeter, LSNE uses both a scientific approach and our extensive experience to develop and optimize the lyophilization cycle of your drug substance.  Our process development team will determine the critical temperatures of your product;  glass transition temperature, eutectic melting temperature, and collapse temperature, and will use this information to  design your cycle and troubleshoot your formulation. Regardless of your stage in the manufacturing process, whether preclinical, clinical, or commercial; LSNE will work with you to improve your product stability while producing an elegant lyophilized cake.

Our staff has developed and optimized over 150 lyophilization cycles in our six dedicated development lyophilizers.   With efficiency in mind, LSNE focuses on producing cycles which are scalable, reproducible and commercially desirable, while prioritizing low residual moisture and pharmaceutical elegance in the end product. The transition from lab scale to clinic is seamless when working with LSNE because we also offer cGMP fill/finish and lyophilization for clinical and commercial material.  Utilizing this approach enables you to expedite timelines while minimizing risk as you move toward commercialization.

       

      Process Development – Testing Capabilities

      • Modulated differential scanning calorimeter (mDSC)
      • Freeze drying microscope (FDM)
      • Research and development stability studies
      • Karl Fischer, osmolality, reconstitution time, concentration, pH, density, HPLC