INSIGHTS ON QUALITY CONTROL

• Choosing The Right Sterility Strategy For Powder Injectables

  Developing powder injectables requires matching sterilization to product traits. Early cross-functional planning and tight contamination controls build sterility assurance before clinical work starts.

• 5 Common Pitfalls In CGT Facility Design Planning And Implementation

  With shifting needs and requirements in advanced therapy manufacturing, embedding infrastructure flexibility is vital. Discover how to balance these variables for long-term success.

• Esco IntelliGlove Tester (EIGT)

  Ensure sterility with wireless glove leak testing. Align with Annex 1 and ISO standards through portable, traceable, and cable-free integrity checks that optimize cleanroom safety and workflows.

• Building R&D Knowledge Into GMP Documentation

  Integrating R&D knowledge into GMP documentation ensures consistent aseptic powder fill‑finish processes by capturing material insights, defining controls, and enabling reliable, knowledge‑driven manufacturing.

• Controlling Nitrosamine Risk In Drug Products: Detection, Formation, And Control Strategies

  7/31/2026

  Bioprocess control relies on clear insight into cell health. Automated tracking cuts risk, saves time, boosts yield, and helps scale up fast to ensure smooth, top quality batch production runs daily.

• Predicting Drug-Loading Limits In Tablet Formulations

  7/15/2026

  Learn how predictive percolation modeling identified critical drug-loading limits of ~20% for crystalline API and ~15% for SDD forms, cutting tablet formulation trial-and-error significantly.

• Minimizing Particulate Risk

  5/13/2026

  While visible particles often draw immediate attention, visual inspection alone is insufficient, as subvisible particulate matter can pose equally significant risks to patient safety.

• Contamination Control Strategy With QRM Principles

  11/19/2024

  Contamination Control Strategies (CCS) have long been a main concept, but advancing requirements and regulatory expectations create a challenge. Learn how to be effective and compliant with your CCS.

• Sterilization Of APIs – The Alternative: Sterile Filtration Following Aseptic Processing

  5/21/2026

  When terminal sterilization isn't an option for heat- or radiation-sensitive APIs, sterile filtration with aseptic processing protects quality. Get the technical framework.