Lyophilization

Lyophilization manufacturing area

Understanding that optimizing lyophilization cycle times and improving stability for complex injectables is a critical component of parenteral product development, Biopharma Solutions established the Lyophilization Center of Excellence, an industry-leading resource center focused on the development of high-quality freeze drying. Dr. Gregory Sacha and Wendy Saffel-Clemmer, distinguished scientists and educators, lead our team of scientists who can assist with modifications and formulas to help maximize the potential of your lyophilized products.

Interested in learning more about lyophilization? Please visit our Resources center for white papers and scientific papers on the subject.

WE OFFER:

  • Targeted lab-to-product correlation for optimum manufacturing and cost efficiencies
  • Six research freeze-dryers for development of freeze-dry cycles for future clinical manufacture
  • Robotic loading/unloading of lyophilizers to minimize handling and microbial exposure
  • Knowledge of milling and homogenizing
  • Expertise and innovative solutions to overcome protein aggregation stability problems
  • Proven scientific approach to cycle development vs. traditional trial-and-error techniques
  • State-of-the-art analytical methodologies for protein biophysical characterization and measurement of protein aggregates
  • Expertise in thermal characterization, capillary electrophoresis, including cIEF and cGE