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WHITE PAPERS AND CASE STUDIES

• Process Development For Lyophilized Products

  Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.

• Vial Fogging: Practical Considerations For Vial Selection

  Vial fogging is a common phenomenon observed in lyophilized biologic drug products. This document presents two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.

• ICH E6(R3) In Effect: Transforming Quality Management For CGT Trials

  Discover how the updated ICH E6(R3) guideline supports the speed and complexity of CGT manufacturing, enabling flexible, risk‑based decisions and quality systems built to scale therapies safely.

• Leading European CDMO For Drug Product Manufacturing

  As timelines tighten and regulatory demands grow, discover how a European CDMO delivers integrated solutions from aseptic fill and finish to packaging and release.

• The Future Of Regulatory Operations

  The pathway to enhancing reliability, compliance, and efficiency across lifecycle management will require embracing technology and process improvement if organizations want to achieve their goals.

• Compliance Auditing: Diving Into Common Critical Findings

  Review critical findings in compliance audits, highlighting frequent issues, their impact on operations, and steps companies can take to improve regulatory compliance.

• Preparing For Disease X: Effective Vaccine Development In The Face Of A Future Pandemic

  CDMOs are playing a critical role in the global effort to prepare for future pandemics. Learn how innovative strategies and flexible platforms are helping to ensure a swift and effective response plan.

• Connecting Quality Management, Patient-Centricity, And Business Value

  Examine why organizations must integrate data and processes to enhance quality and insights to improve operational efficiency, patient health, and regulatory compliance.

• State Of Clinical Trial Technology: The AI Inflection Point

  Digital maturity gaps are widening in clinical research. Connected workflows speed insights and execution, while manual processes leave organizations increasingly behind.

• Revolutionizing Biofilm Research: High-Resolution, Real-Time Imaging with ZeGage Optical Profiler

  A university lab optimized biofilm research with Zygo’s ZeGage Optical Profiler, enabling high-resolution, real-time, non-contact imaging that accelerates data collection, enhances accuracy, and preserves biofilm integrity.

• How To Unlock The Secret To Repeatable, Scalable Low Turnover

  Here, we explore the evolution of a 10-year partnership and extrapolate the principles that create cohesive teams and minimize turnover.

• Supplier Quality And The True Cost Of Recalls

  Recalls can cost millions (or even billions) and threaten a company’s public perception. Discover how to minimize recall costs and enhance compliance with effective quality management strategies.