• Beyond Dissolution: Why Today’s BCS Class II Pipeline Requires a More Predictive Approach

    Drug molecules are becoming more complex. As pipelines continue to be dominated by poorly soluble compounds, the dynamic of solubility and absorption will remain central to development success. read more
  • Packaging Is Tough

    The lesson here isn’t that packaging is bad. It’s that packaging is where all the science, formulation work, and quality control finally meets a real person standing in a real kitchen. If the patient can’t get the product out in one piece, all of that great work ends up in crumbs on the counter. read more
  • Typical and Representative, Part 1

    As technology in endotoxins and pyrogens testing changes, and as the basic research advances our understanding of pyrogenicity, fifty-year-old assumptions and decisions should be revisited, if not challenged. Given that it is neither typical nor representative of potential contaminants, is the current calibrant still an appropriate analyte for endotoxins and pyrogens testing? read more
  • Beyond the Plate: Where Biofluorescent Particle Counting Can Reduce Errors and Strengthen Contamination Control

    The goal is not to eliminate plates. It is to reduce the number of reasons to open or intervene in the isolator. By supplementing traditional environmental monitoring with real-time BFPC, manufacturers can preserve the value of growth-based methods while reducing avoidable interventions—and, consequently, the number of investigations triggered by the monitoring process itself. read more
  • Featured Documentary: A Solid Dosage Future

    While biopharmaceuticals continue to grab much of the limelight in the pharmaceutical industry, the fact is solid dosage products (tablets, capsules, pills, etc.) still account for the majority of medicinal products made worldwide. The reasons for this market share are abundantly clear: patients are familiar with the dosage form and are comfortable using it. In addition, the industry has many decades of experience designing, formulating, testing, manufacturing and packaging solid dosage products. The knowledge base is extensive. read more
  • Watch Video: The Clean Facility of the Future - Advanced Microbiology Techniques for Cleaner Facilities and Purer Products

    Learn about the tools, techniques, services and best practices being used to manufacture high quality products while minimizing contamination and error in the Clean Facility of the Future Documentary. read more