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BioPharma Solutions BioPharma Solutions
Sterile Contract Manufacturing



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
  • Four 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

You can feel confident knowing that your molecule is in good hands with our scientific team, who bring a combined 250 years of experience in pharmaceutical development and injectables, as well as several other notable achievements:

  • Published 120+ articles/presentations in the past five years
  • Developed and optimized lyophilization formulations and cycles for >30 clients
  • Award-winning and industry recognized:
    • Recipient of the 2007 AAPS Pharm Tech Section Research Achievement Award
    • Two AAPS Fellows
    • Chairman of the USP Expert Committee on Parenteral Products
    • Professors of international parenteral science and technology courses
    • Author of “Parenterals” chapter in Remington’s: The Science and Practice of Pharmacy
    • Former college of pharmacy professors, currently adjunct professors
    • Editors and authors of Development and Manufacture of Protein Pharmaceuticals
    • Author of three editions of Parenteral Quality Control
    • Author of Sterile Products book available Fall 2010

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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