Industry Insights

  1. Considerations For Late-Stage Customization 4/18/2019

    Learn how streamlining operations and using a process called Late Stage Customization you can significantly reduce costs to ensure a more efficient, flexible supply chain.

  2. FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities 5/3/2021

    On April 14, 2021, the FDA released a new guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. This article discusses planning, conducting, and concluding a remote interactive evaluation under this guidance, and shares how to submit public comments for FDA consideration.

  3. Erasing Disease: How Gene Editing Is Changing Genetic Therapies 3/15/2017

    We are all born with disease hardwired into our genome. A few mutations paired with lifestyle choices or other environmental factors can lead to asthma, Alzheimer’s, and thousands of other conditions. One out of every 100 of us suffers from a disease caused by a mutation in just a single gene. A particular group of drugs, antisense and gene therapies, tackle these disorders at their origin, the faulty gene or its expression. But even the most successful of these genetic therapies provide only a treatment.

  4. Clearing The Fog On New First Air Visualization Expectations 3/18/2026

    Assessing first air using standard smoke studies is qualitative in nature, and it's difficult to establish clear criteria. Here is how regulator positions are evolving.

  5. Bringing Data Quality To The CRO-BioPharma Partnership 2/10/2023

    Learn about CRO use in response to growth in pharma companies, R&D spending and activity, and rising number of drugs in preclinical trials.

  6. Improve Solubility And Spray Drying Throughput For Brick Dust Compounds

    This paper presents three approaches to address poor solubility in organic solvents for spray drying as well as case studies outlining their successful application during development.

  7. 505(b)(2) CMC Basics: Aligning Chemistry, Manufacturing, And Controls With Clinical Trial Phases 8/8/2022

    While the successful completion of clinical trials can invite and maintain funding, those trials are not meaningful without an appropriately designed, manufactured, and controlled drug product.

  8. Ensuring Performance And Compliance: Successful FAT Of Filling Line Isolator For Creative Lifesciences, Taiwan 3/19/2026

    Rigorous Factory Acceptance Testing ensures filling line isolators meet performance and safety standards. This validation is vital for aseptic integrity and protecting both product and operator.

  9. Increasing Transparency And Confidence Through Real-Time Data Sharing

    A digital transformation of biomanufacturing offers a new path for continuous monitoring and optimization of process performance, which would ultimately lead to greater efficiency in drug production.

  10. Fluid Flow Effects In A Chromatography Column For Mechanistic Models 5/23/2022

    Flow patterns are three-dimensional in space, and chromatography fluid dynamics (CFD) models should also be three-dimensional in space. Understand fluid dynamics within a chromatography column.