INSIGHTS ON QUALITY CONTROL

• Seamlessly Integrating An E-WorkBook With A Customer's LIMS

  Explore the story of a global biopharma company's integration of E-WorkBook with their LIMS, automating ADA study reports, saving significant time, and enhancing data accuracy.

• Quantitative Determination Of Amorphous And Crystalline Drug In Polymer Microspheres

  Biodegradable polymer microspheres control drug release through crystalline and amorphous properties, analyzed using DSC, MDSC, and TGA to determine composition and stability for precise delivery.

• Regulatory Compliance And Advanced Solutions For Aseptic Environmental Monitoring

  Modern aseptic monitoring requires a shift from periodic checks to risk-based strategies. Learn how to integrate particle and environmental data to meet Annex 1 standards and ensure patient safety.

• 0.45 m/s ±20% At Working Position In Closed Sterility Testing Isolators: Requirement Or Convention?

  Balance compliance and efficiency in sterility testing. Explore how a risk-based approach to airflow and isolator technology aligns with Annex 1 while optimizing contamination control.

• Inline Checkweighing Of Packaged Products In Manufacturing

  12/29/2025

  Accurate inline checkweighing is vital for quality control. Learn how system design, software, and regulatory compliance work together to overcome high-speed production challenges.

• The Role Of Quality By Design In Pharmaceutical Tablet Development

  7/30/2024

  Quality by Design (QbD) ensures efficiency and high standards in pharmaceutical tablet development. Explore how this proactive approach transforms manufacturing processes and enhances product quality.

• From Day One Success To Everyday Improvement: The OR → OE Continuum

  11/24/2025

  Bridging the gap between initial startup and long-term sustainability requires a unified strategy. Learn to transform early readiness metrics into a durable operating system that drives continuous performance improvements.

• Advancing Cell Therapy Manufacturing: Rapid Sterility Testing

  5/7/2024

  The rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.

• Accelerate Biologics Product Release With Seamless Viral Testing

  6/23/2025

  Explore viral safety testing for biologics, focusing on prevention, detection, and removal strategies, updated regulatory guidance, and common challenges in unprocessed bulk testing.