INSIGHTS ON QUALITY CONTROL

• Chromatography In Biologics Manufacturing: Purification Science, Resin Applications, And System Qualification

  Explore chromatography fundamentals, resin selection strategies, and the regulatory frameworks required to qualify automated systems for compliant, commercial-scale biologics manufacturing.

• Don't Let Seals Break Your Batch: A Risk-Based Approach To Column Maintenance

  Optimize biopharmaceutical manufacturing by implementing risk-based seal maintenance. Tailor replacement protocols using data and advanced monitoring for enhanced efficiency and compliance.

• Organ-Chips Outperform Animal Models And Spheroids

  Examine how 780 human Liver-Chips were assessed for their ability to predict drug-induced liver injury from small molecules.

• The Problem With Construction Quality

  Data center construction quality management is inadequate, with issues traced to human error. A stronger focus on quality control and assurance is needed for success.

• Your Guide To Precise And Robust Separation Methods

  11/12/2025

  Discover a detailed guide to characterizing GLP-1 receptor agonists that covers advanced LC-MS and SEC-MALS workflows for impurity profiling, stability testing, and aggregate analysis.

• 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.

• 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.

• Monitoring Microbial Contamination Of Mammalian Cell Cultures

  2/21/2025

  Mammalian cells are widely used to produce complex processed molecules. Explore a system that effectively detects microbial contamination in mammalian cell cultures and utilizes a newly formulated lysis buffer.

• Lessons From FDA 483s And Warning Letters: Cleanroom Compliance

  12/8/2025

  Learn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.