INSIGHTS ON QUALITY CONTROL

• A CDMO's Take On Psychedelic Formulation

  Psychedelics show therapeutic promise, but face major formulation and regulatory hurdles. Advances in delivery and neuroscience may unlock new mental‑health treatments.

• Software Simplifies 21 CFR Part 11 and Annex 11 Compliance

  21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

• 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.

• Quality By Design In The Pharmaceutical Industry

  Real-time release and digital quality management, powered by PAT, are driving efficiency and compliance, reshaping how manufacturers achieve speed, consistency, and competitive advantage.

• How A Global Biosimilars Company Cut Manual Data Errors By 50%

  5/8/2026

  Learn how a global biopharmaceutical leader halved transcription errors and integrated over 350 instruments to accelerate the development of high-quality, clinically proven biosimilars.

• CMO Validation As A Service

  8/20/2024

  Learn about the highly successful commissioning and qualification of Wheeler's Oklahoma City CDMO facility with the overarching goal of ensuring all equipment was qualified for a Phase 3 clinical production campaign.

• Tackling Residual DNA Testing In Biotherapy Manufacturing

  7/16/2025

  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.

• Human Performance In Pharma: Strengthening The Biotech Workforce

  11/24/2025

  Transforming the pharma workforce requires strategic partnerships and a shift toward behavioral and operational readiness, moving beyond simple technical training to ensure performance and compliance.

• Thermal Analysis In The Pharmaceutical Industry

  12/30/2024

  Thermal analysis techniques provide valuable insights into pharmaceutical material properties, ensuring compatibility, stability, and quality control in drug development and production processes.