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

31. 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.

32. 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.

33. Guide To PUPSIT And Annex 1 In Aseptic Processing 12/5/2024

    Pre-use, post-sterilization integrity testing (PUPSIT) ensures filters remain undamaged and effective during aseptic manufacturing. Discover how you can successfully perform PUPSIT with proven solutions.

34. 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.

35. 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.

36. A Risk-Based Approach To Validation Studies For Sterilizing-Grade Filtration And Single-Use Systems 10/3/2024

    One way to address risk related to product quality is by implementing a Question-Based Review approach. Read on to learn about this approach and its advantages.

37. Nitrosamine Analysis: Solutions For Risk Management And Analytical Testing 8/22/2024

    Testing for nitrosamines is essential in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug products to ensure safety and compliance.

38. PUPSIT As Part Of A Contamination Control Strategy (CCS) 8/21/2024

    Learn about the changes introduced in the latest revision to EU GMP Annex 1, and gain insight into the components that should be part of a PUPSIT risk assessment.

39. When Should Filter Validation Be Performed? 8/21/2024

    Learn about a program that has been developed to facilitate risk mitigation before process-specific filter validation is performed.

40. 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.