INSIGHTS ON QUALITY CONTROL

• Manufacturing Solutions

  Explore a cutting-edge service in powder blending, encapsulation, tablet compression, and on-site laboratory testing that meets the highest standards to ensure exceptional quality and compliance with cGMP regulations.

• Filling The Sterility Testing Gap: Traceability And 21 CFR Part 11 Compliance

  Watch to learn about a solution that offers digital information for every stage of a sterility test while remaining compliant with 21 CFR Part 11.

• Understanding cGMPs For Phase 1 Investigational Drugs

  Learn how a structured, risk-based approach to early-phase manufacturing can help streamline processes, reduce costs, and accelerate the path to first-in-human trials while meeting FDA cGMP guidelines.

• Tackling Residual DNA Testing In Biotherapy Manufacturing

  Controlling residual host cell DNA is critical for the safety and efficacy of biotherapeutics. Learn about robust, highly sensitive analytical methods for effective DNA clearance and process control.

• 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.

• 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.

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

  7/28/2025

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

• 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.

• Pave The Way To High Productivity With Continuous Manufacturing For Pharma

  12/12/2025

  Continuous manufacturing delivers agility and precision for pharma, combining automation, reduced manual steps, and quality control to meet regulatory and cost pressures while accelerating development.