INSIGHTS ON QUALITY CONTROL

• Don't Lose Sight Of Ophthalmic Injectables' Regulatory Complexity

  Intravitreal injectables face some of the strictest regulatory scrutiny in drug development. Learn what sponsors need to know about EU GMP Annex 1, USP standards, and container closure integrity to stay compliant.

• Leachables Method Development, Validation And Relevant ICH References

  It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.

• Practical Considerations For Aseptic Gowning In Contamination Control Strategies

  Master the complexities of aseptic gowning and Annex 1 compliance. Explore risk-based strategies to mitigate human-source contamination and strengthen your facility's sterility assurance.

• CPhI North America 2026: CDMO Partnerships With Mikart

  Event-driven blogs highlighting how sponsors can evaluate CDMO partnerships, outsourcing strategies, and formulation development discussions across major 2026 industry conferences.

• 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.

• Enhance Peptide Innovation With A High-Quality Supply Of Building Blocks

  1/29/2025

  To leverage the benefits of peptide therapeutics, identify an experienced chemical material manufacturer that can produce unique peptide building blocks with quality, efficiency, and continuous compliance.

• Leadership Perspectives From The Grand Opening of Flamma's Honkai 2 Facility

  5/22/2026

  A two-day celebration in Dalian highlighted a major global investment milestone, featuring leadership perspectives, opening ceremonies, and the strategic vision behind expanded cGMP manufacturing capabilities.

• The Importance Of Having A Strong Reject Characterization Program

  2/26/2026

  Discover how linking inspection results to systematic defect analysis strengthens data integrity, accelerates root cause resolution, and satisfies regulatory process knowledge requirements.

• Discovery Core Rheometer: Easy To Use. Hard To Beat.

  5/6/2026

  Explore how advanced rheological testing delivers deeper insight into material behavior, from flow and yield stress to quality control decisions, using guided workflows that simplify setup.