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WHITE PAPERS AND CASE STUDIES

• Revolution In The EU Pharmaceutical Legislation Ahead

  Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.

• Accelerating Approval Pathway For Phase III Ovarian Cancer Trial

  A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.

• Life Sciences Corporation Implements eLogbooks Across 15 Sites

  New regulations challenged how surgical kits were tracked and processed across 15 U.S. sites. Discover how one team balanced compliance and efficiency to keep life-saving procedures on schedule.

• 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.

• FDA Recommendations For Gene Therapy For PMDs

  Explore insight into the strategies and FDA recommendations for executing gene therapy development programs, specifically for primary mitochondrial diseases (PMDs).

• How Are 5G Non-Terrestrial Networks Driving Satellite Link Impairment And Hardware-In-The-Loop Emulation?

  Explore how 5G Non-Terrestrial Networks integrate satellites, HAPS, and IoT to deliver seamless global connectivity, expanding 3GPP standards beyond traditional terrestrial limits.

• How Community Oncologists View CAR T-Cell Therapy Possibilities And Challenges

  Learn how a partner with innovative solutions aimed at overcoming the barriers that limit the real-world impact of CAR T-cell therapy can make these advanced therapies more accessible and affordable.

• 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.

• Process Scale Column Packing Instructions

  Explore a comprehensive guide to using DurA Cycle A50, a high-capacity, alkaline stable protein A affinity chromatography resin for the downstream processing of mAbs and recombinant proteins.

• 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.

• 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.

• Pharma Company Digitizes Paper Logbooks To Increase Data Accessibility

  A top pharma producer modernized its operations by digitizing paper-based logbooks. Discover how this shift supports compliance and scalability across global manufacturing environments.