Business Process Management

WHITE PAPERS AND CASE STUDIES

• A Risk-Based Approach To Plasmid DNA And mRNA Process Development

  Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.

• Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer

  Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.

• Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker Assays

  Receptor occupancy (RO) assays assess drug-target engagement and support PK/PD modeling. Accurate RO requires customized assays using stabilized blood to monitor CD6 modulation in autoimmune therapy.

• Quality Assurance In IVT RNA Vaccine Development Using Electrophoresis

  Discover advanced solutions for IVT RNA synthesis, focusing on enhancing fidelity in throughput, innovative technologies, and methodologies to optimize your RNA research and development processes.

• Atlantic Research Group Builds Competitive Advantage With Medrio EDC

  By using Medrio’s EDC platform, learn how Atlantic Research Group was able to achieve the flexibility needed to span multiple therapeutic areas and eliminate redundancy in documentation.

• Intro To USP <1062> - What It Is And Why You Should Use It

  Knowing how to use USP <1062> helps manufacturers manage the wide variety of factors that can exacerbate production costs, or result in no product at all.

• Electronic Batch Reporting

  Learn how a CDMO automatically created a comprehensive batch report model to drive their reporting and speed root cause identification of quality failures with an Industrial DataOps software solution.

• Leeton Shire Improves Efficiency And Service Levels With An Affordable, Intuitive Digital Solution

  Although Leeton Shire already had some digital technologies in place, such as SCADA, GIS and AMI, they lacked hydraulic modeling capabilities and expertise — which is why they turned to Qatium’s open and secure water management platform.

• Why Early Market Access Planning Is Crucial In CGT Commercial Strategy

  Bringing cell and gene therapies (CGTs) to market and ensuring patient access is a complex process. Discover how developing a market access strategy and partnering with experts can help.

• NuGenesis 9.3 – What's New

  Explore the latest features of a user-centric lab management system that comprises data, workflow, and sample management capabilities to support the entire product lifecycle.

• Key Considerations For Selecting A Solenoid Valve In Health & Science Applications

  Solenoid valves are vital in medical devices, enabling precise fluid and gas control. Explore customizable, high-reliability valves that optimize performance while conserving space, weight, and power.

• Perspectives On Performance, Scalability, And Regulatory Compliance

  Here, we discuss the challenges and solutions for cell and gene therapies, focusing on performance, scalability, and regulatory compliance to accelerate commercialization and improve patient access.