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WHITE PAPERS AND CASE STUDIES

• Exploring Perfusion Technology For Virus Manufacturing Process Intensification

  Perfusion cell culture technology supports high cell densities and product yields for viral vaccine manufacturing, offering a reliable way to produce high-quality cells at a commercial scale.

• A Synergy Of Excellence: Partnership During Unprecedented Times

  Learn how a partner with the right experience and capabilities is crucial to support accelerated GMP manufacturing and ensure novel vaccines and therapeutics receive regulatory approval.

• 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.

• Challenges And Solutions In Lyophilization Development For ADCs

  Successful ADC lyophilization requires a robust, individualized process driven by thermal characterization using DSC and FDM to define the critical parameters for stability and efficient manufacturing.

• Cell And Gene Therapy Field Quiet In Q2

  While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.

• Relieving The Strain Of Publishing During Regulatory Registration

  Go inside how an expertly handled NDA submission for a biopharma company ensured timely FDA approval despite challenges.

• Overcoming The Top 3 Challenges In Setting Up And Managing Clinical Trials

  Navigating the intricacies of clinical trials demands adept handling of document management, regulatory compliance, and financial forecasting. Learn key strategies for overcoming these hurdles.

• Is Sustainability The Key To Agile Biopharma Manufacturing?

  In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.

• ProPharma Supports A Contract Manufacturer's Form 483 Response

  Learn how a small contract manufacturer navigated a complex FDA 483 Observation notice and implemented effective remediation strategies that addressed multiple system-wide concerns.

• Lean Six Sigma Methodology Drives Cost Savings: 2 Success Stories

  Unlock significant lab efficiency and financial gains. See how focused optimization of workflows and asset management led to substantial cost savings and reclaimed six-figure value in consumables.

• Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning

  The piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.

• A Scalable Single-Use Two-Step pDNA Purification Process

  Evaluate the performance of a single-use two-step plasmid purification process, and see how it compares to the existing three-step purification method.