Regulatory Articles. App Notes, Case Studies. & White Papers

  1. Cell And Gene Therapy In Conversation 9/8/2025

    Industry experts share strategies to overcome key barriers in CGT development, from reproducibility to scale-up. Gain practical insights to help teams move faster and more reliably toward commercialization.

  2. Navigating The Regulatory Space To Biosimilar Approval 9/1/2025

    The biosimilar patent cliff is reshaping pharma, creating unprecedented opportunities for biotech and CDMOs. Explore expert regulatory support that can help you navigate this shift with confidence.

  3. Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines 8/6/2025

    As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.

  4. Risk Assessment Services Align With FDA Guidance For Gene-Edited Human Gene Therapy Products 7/29/2025

    Navigate the FDA's gene therapy guidelines with advanced risk assessment strategies. Optimize gene editing and ensure regulatory alignment for safer, more effective therapies.

  5. The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly 3/3/2025

    In your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.

  6. How Ergonomics And Cleaning Ease Reduce Repetitive Stress Injuries And Contamination In Pharmaceutical Lab Workflows 2/3/2025

    The repetitive nature of routine laboratory procedures can put technicians and scientists at risk for repetitive strain injury. Routine activities often include reoccurrence of the same movements over and over, which can take a toll on hands, wrists and shoulders and ultimately can lead to serious damage. Choosing the right tools can make all the difference.

  7. Advancing Drug Safety And Improving R&D Productivity With The Liver-Chip S1 12/10/2024

    Explore how the Emulate Liver-Chip S1 revolutionizes predictive toxicology by mimicking human liver biology, achieving superior sensitivity and specificity.

  8. Perspectives On Performance, Scalability, And Regulatory Compliance 10/28/2024

    Here, we discuss the challenges and solutions for cell and gene therapies, focusing on performance, scalability, and regulatory compliance to accelerate commercialization and improve patient access.

  9. Resolute® BioSC Pilot: Designed For Effective And Consistent Chemical And Microbiological Cleaning 10/10/2024

    Issues related to cleaning and cleaning validation are some of the most common concerns that arise in FDA Warning Letters. Discover how to ensure you pass your cleaning validation tests.

  10. Harmonizing Regulatory Guidelines For Assay Validation 7/24/2024

    Explore a detailed process for validating ligand-binding assays, particularly for Fcγ receptor binding analytes or other structural isoforms.