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.

• Scaling Success: A Blueprint For Flexible Biometrics Partnerships

  Learn how a micro-FSP model and integrated biometrics team can scale from specialized support to a full-service solution, ensuring agility and consistency as clinical trial needs evolve.

• Smart Scaling For Cell And Gene Therapies

  To meet patient demand, advanced therapy manufacturing processes must be commercial ready. CGT sponsors can mitigate risk and protect viability by partnering with a CDMO that prioritizes scalability.

• 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.

• Revolutionizing European Football With UWB Micro-Location

  See how UWB micro-location technology was utilized by European League Football to address pandemic-era challenges, but quickly transformed into a vital tool for player analytics and safety monitoring.

• The GxP Digital Maturity Model

  Explore how the GMP Digital Maturity Model guides life sciences companies through five stages to improve compliance, efficiency, and profitability with strategic digital adoption.

• Rethinking Peptones As First-Line Optimization Tools

  Peptones enhance CHO cell growth, viability, and yield, offering a fast, low-risk way to improve bioprocess performance without major process changes.

• Avoid Clinical Manufacturing Pitfalls With These Tech Transfer Best Practices

  Ensure a smooth transition from development to manufacturing by implementing a strategic tech transfer process. Review key practices for effective communication, collaboration, and risk mitigation.

• Build An AAV8 Platform: Lessons From A Collaborative Development Journey

  Explore how a modular AAV8 platform enables scalable, GMP-ready gene therapy manufacturing with reproducible outcomes, streamlined tech transfer, and adaptability across serotypes.

• Modular Automation: The Plug-And-Produce Opportunity For Life Sciences

  Explore how the advantages of modular automation in life sciences emphasize flexibility, efficiency, and cost savings through plug-and-produce systems that enhance production adaptability and speed.

• Digitalizing Batch Records In Pharmaceutical Production

  Pharma manufacturing embraces cutting-edge automation, yet outdated paper-based documentation hinders efficiency and delays batch releases. See how digital solutions can transform compliance.

• Understanding Biosafety Levels

  Compliance with biosafety levels (BSLs) is crucial in ensuring that your laboratories meet stringent standards to protect staff and prevent the escape of biological agents.