Latest Articles

  • From Kirk’s Conquests to Cancer Cures: Space Gets a Day Job

    Nobody wrote the script where space spends its days quietly growing protein crystals for a Merck immunotherapy drug. And yet, here we are. read more

  • Aligning Environmental Monitoring Expectations with Scientific Realities

    Considering the advances in aseptic processing and their effectiveness in eliminating the primary sources of contamination (i.e., human activity), it is not our intent to entirely disparage the value of monitoring. Environmental monitoring has some value in trend analysis within an overall contamination control strategy. However, it is not a control mechanism. 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

  • PEG Alternatives: Synthesis and Evaluation of Novel Polymers in mRNA-LNP Formulations

    The synthesis and evaluation of novel polymers have provided highly effective and safer alternatives to PEG in mRNA-LNP formulations, directly confronting the fundamental challenge of the PEG dilemma. This dilemma is the primary bottleneck for advanced nucleic acid therapeutics. 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