INSIGHTS ON REGULATORY COMPLIANCE

• Enabling Real-Time Data Through A PAT Integration

  Explore how Raman models and autosampling tools enable real-time bioprocess control, delivering richer data and automation. Learn how PAT technologies can help close data gaps and support smarter, more efficient biomanufacturing strategies.

• Why Perform A D-Value Study? Reference Review

  Understanding how a product influences microorganisms' resistance is crucial. Read about relevant standards and references as well as recommendations for performing product D-value studies.

• What Does The New Annex 1 Mean For The Aseptic Fill/Finish Industry?

  The revised Annex 1 focuses on harmonizing regulations across the pharmaceutical manufacturing industry, prompting the pharmaceutical industry to strategize to achieve the best compliance method.

• FAQs On The Revised EU GMP Annex 1: Volume 2

  Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing component readiness: product, process, protection, and proof.

• Mold In Cleanrooms: A Persistent Threat And The Case For Proactive Bio-Decontamination

  11/17/2025

  Learn how a comprehensive investigation and systems-level bio-decontamination strategy successfully eliminated persistent mold contamination in a vaccine manufacturing facility's high-risk area.

• Ready-To-Use Cartridges: Ensuring Compatibility For GLP-1-Based Drugs

  8/27/2024

  Ready-to-use cartridges for GLP-1 applications offer safe, reliable self-administration. See how they can minimize complexities and better align with the stringent demands of modern manufacturing.

• How To Reduce Batch Loss In Biopharma Production

  12/12/2025

  Batch failures in biopharma remain costly despite improvements. Learn the leading causes in downstream purification and how supplier expertise can help reduce risk and protect production.

• Developing A Comprehensive Regulatory Approach For LNP Drugs

  2/26/2024

  The path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.

• Development Of Improved Chromatographic Methods

  7/31/2025

  Explore the evolving role of GLP-1 agonists in weight management and diabetes care, and discover the urgent need for advanced chromatography methods to ensure pharmaceutical quality and safety.