INSIGHTS ON QUALITY CONTROL

• Improving Bioprocess Monitoring And Control With Multivariate Data Analysis

  Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.

• ISO/TR 14644 -21:2023 Cleanrooms And Associated Controlled Environments — Part 21: Airborne Particle Sampling Techniques.

  Avoid common sampling errors and ensure cleanroom compliance. Master correct probe placement and tubing configurations to align with the latest industry standards and improve data accuracy.

• Contamination Control Strategy: Compressed Gas Monitoring Of Microbes

  Microbial survival during gas decompression is a proven risk. Learn why point-of-use monitoring is essential for Annex 1 compliance and how to ensure process gas purity in sterile environments.

• Delivering Value Across Sites With Unified Quality Operations

  Standardizing quality processes across 14 sites has enabled faster lead times. Discover how a unified platform reduces complexity, improves compliance, and delivers greater value for customers.

• Antibody-Drug Conjugates – Catalysts For Chemistry

  5/16/2024

  Review the complexities of developing linkers – chemical moieties which attach a drug payload to an antibody – and considerations when identifying a CRO for ADC research and development.

• Ensuring Compliance For Virtual And Hybrid Pharmaceutical Companies

  10/16/2025

  Proactive, risk-based oversight must be established to manage outsourced GXP activities. This requires a robust QMS and comprehensive quality agreements to safeguard product quality and data integrity.

• 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.

• How To Double Up With A CDMO To Reduce Risk

  12/12/2025

  Parallel operations with a CDMO can reduce risk and accelerate timelines by enabling simultaneous process development and manufacturing. Learn how this approach supports facility design.

• Method Migration Of A Normal Phase HPLC Method For Tocopherols

  9/17/2024

  The ability to migrate methods across HPLC systems is essential as systems are updated. Review a normal phase method that provides a means for quantification of tocopherols in vitamin supplements.