Insights On Regulatory Compliance

  1. Chromatography In Biologics Manufacturing: Purification Science, Resin Applications, And System Qualification 11/24/2025

    Explore chromatography fundamentals, resin selection strategies, and the regulatory frameworks required to qualify automated systems for compliant, commercial-scale biologics manufacturing.

  2. The Problem With Construction Quality 10/21/2024

    Data center construction quality management is inadequate, with issues traced to human error. A stronger focus on quality control and assurance is needed for success.

  3. Advances In Regulations For Viable Environmental Monitoring 2/21/2025

    Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.

  4. Optimal Microbial Sampling Criteria 6/24/2025

    Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.

  5. Biopharma Supply, Reimagined: Blarney, A Climate-Neutral Facility For Best-In-Class Filters 11/11/2025

    Explore how a new, climate-neutral manufacturing facility strengthens biopharma supply chains. Understand the benefits of its advanced filtration technologies and commitment to environmental sustainability.

  6. Environmental Monitoring For Aseptic Filling 3/6/2025

    Explore regulatory interest in modern environmental monitoring for aseptic filling, the benefits of biofluorescent particle counters, and their role in enhancing drug product safety and quality.

  7. Development Of Separation Methods For GLP-1 Synthetic Peptides 6/30/2025

    Explore a novel HPLC-UV/MS method for analyzing GLP-1 analogs to address critical challenges in peptide separation, impurity detection, and performance for improved reproducibility.

  8. The Ultimate Guide To Biological Indicators 5/27/2025

    Discover why biological indicators are the gold standard for sterilization validation in pharmaceutical and medical device manufacturing, as well as how choosing the right one ensures safety, compliance, and product integrity.

  9. Shaping The Future Of Process Intensification With Digital Solutions 10/3/2025

    Discover how automation, analytics, and AI are driving smarter process intensification and enabling a shift toward connected, continuous manufacturing.

  10. Key Considerations When Developing Your Combination Product 2/20/2024

    Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.