Lyophilization
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.
