- Selection of Containers/Closures for Use in Lyophilization Applications: Possibilities and Limitations
Akhilesh Bhambhani, Ph.D., & Babu M. Medi, Ph.D Merck & Co.
- Reporting and Analyzing Drug Dissolution Results: A Systematic Approach
Saeed A. Qureshi Senior Research Scientist, Therapeutic Products Directorate, Health Canada, Banting Research Centre
- Metal Leachables in Therapeutic Biologic Products: Origin, Impact and Detection
Shuxia Zhou, Lavinia M Lewis, Ph.D., & Satish K. Singh, Ph.D. Pfizer Inc.
- Particle Size Specifications for Solid Oral Dosage Forms: A Regulatory Perspective
Zhigang Sun, Ph.D., Naiqi Ya, Ph.D., Richard C. Adams, & Florence S. Fang Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration
- Application of Very-High Pressure Liquid Chromatography for Developing Fast and More Efficient Separations within Pharmaceutical Development
Brent L. Kleintop, Ph.D. & Qinggang Wang, Ph.D. Bristol-Myers Squibb Analytical Research and Development
- A Rapid Microbiological Assay to Monitor the Effectiveness of a Vaccine Injector Sanitization Following a Microbial Challenge Procedure
Claudio Denoya, Ph.D.1, Edwin Dawson2, Darwin Sessoms2, Michael Baumstein3 & John Shabushnig, Ph.D.3 (1) Pfizer Global R&D (2) Pfizer Poultry Health (PPH), Animal Health, (3) Pfizer Global Manufacturing
- Application of Raman Spectroscopy in Biopharmaceutical Manufacturing
Zai-Qing Wen, Ph.D., Xiaolin Cao, Ph.D., & Joseph Phillips, Ph.D. Process and Product Development Amgen Inc.
- Functionality and Performance of Excipients in a Quality-by-Design World Part X: Continuous Processing of Pharmaceutical Finished Products
Chris Moreton, Ph.D. FinnBrit Consulting LLC
- Using Process Analytical Technologies for Real Time Monitoring and Quality Assurance in Chemical Development
Jun Chen, Ph.D., Gregory J. Gervasio, Patrick N. Ng, James W. Rydzak & Alireza S. Kord, Ph.D. GlaxoSmithKline
- Top Ten Validation Considerations When Implementing a Rapid Mycoplasma Test
John Duguid Cell Therapy Manufacturing Technical Services Genzyme
- The Flexibility, Quality and Cost of Single Use Recovery Systems in Bio-Pharmaceutical Drug Production
Lindsay Leveen Genentech
- Optimizing the Solubility of Research Compounds How to Avoid Going Off Track
Christoph Saal, Ph.D. Merck KGaA