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BioPharma Solutions BioPharma Solutions
Sterile Contract Manufacturing

Lyophilization

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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. Steven Nail 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.

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 capillary electrophoresis, including cIEF and cGE
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  • Author of Sterile Products book available Fall 2010
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    Interested in learning more about lyophilization? Please visit our Educational Resources center for white papers and scientific papers on the subject.

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