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WHITE PAPERS AND CASE STUDIES

• 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.

• Selecting A New Sporicidal Disinfectant: What The Cleanroom Manager Needs To Know

  This guide helps cleanroom managers evaluate sporicides by efficacy, safety, and compatibility to ensure contamination control without compromising operational integrity.

• Advanced Ozone Disinfection – City Of Fayetteville, Arkansas

  Discover how Fayetteville upgraded wastewater disinfection with advanced ozone technology, improving contaminant removal, reducing energy use, and delivering reliable, sustainable treatment for future regulatory demands.

• Decentralized And Community-Based Solutions Driving Women's Healthcare

  Clinical trials should reflect the affected population by reducing participation barriers and bringing trials to patients to increase inclusion and improve real-world data.

• Facility-Fit-Driven Process Development For A Monoclonal Antibody

  See how proactively designing around plant constraints, using high-capacity resins, and leveraging parallel workstreams resulted in a 50% reduction in processing hours and 25% lower costs.

• Sensors And On-Demand eCOA

  See how one rare disease trial eased caregiver burden by unifying glucose monitoring and patient diaries into a single app with real-time safety alerts.

• Modelling TPDs Utilizing Computational And Medicinal Chemistry Approaches

  Through a carefully executed strategy, see how we identified novel degrader molecules with the right physicochemical properties to achieve robust degradation of the target Protein of Interest (POI).

• Expanding Translational Research Concepts With Genedata Profiler

  The biopharma industry leverages Genedata Profiler to integrate, curate, and analyze diverse R&D data, enabling collaborative, compliant, and AI-driven translational research to optimize drug development.

• Development And Regulation Of Veterinary Monoclonals

  Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.

• Vaccine Clinical Trials Global Landscape Whitepaper (2024)

  The global vaccine trial landscape is undergoing rapid evolution, driven by technological innovations, emerging health threats, and regulatory shifts.

• How To Adopt CSA For Streamlined Computer System Validation

  Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

• Performance Of A Customizable DMSO-Free Cryopreservation Media Formulation

  Cryopreservation enables cell therapy by storing cells long-term. A DMSO-free formula preserves cell viability and health, minimizing toxicities linked with traditional cryoprotectants.