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WHITE PAPERS AND CASE STUDIES

• Forge Boosts Efficiency And Compliance During External Collaboration

  Streamlined collaboration and unified quality systems are helping CDMOs cut review times. Discover how connected workflows improve compliance and efficiency for faster delivery of life-changing treatments.

• Transitioning Your Product From Phase 1 To Phase 2 Clinical Studies

  Strategic partnerships can streamline your transition from Phase 1 to Phase 2 clinical studies, ensuring optimized dosage forms, seamless scale-up, and alignment with patient and study requirements.

• Transforming Development Through Mass Spectrometry Data Analysis

  Mass spectrometry is vital for understanding PTMs in modern biologics. Explore key challenges and how streamlined analysis can reveal deeper, more sensitive insights into biotherapeutic structure.

• Cutting European Methane Emissions Through Advanced Gas Leak Detection

  Reducing methane emissions is crucial in combating climate change, and advanced gas leak detection technology is key to achieving this goal.

• Boosting CMC Regulatory Efficiency In Gene Therapy

  Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.

• How Optics And Flow Cytometry Are Improving Pancreatic Cancer Treatment

  The University of Texas researchers are developing an optical system analyzing cancer cell properties to guide treatments, improving patient outcomes and targeting aggressive cancers like pancreatic.

• American Academy Of Ophthalmology IRIS Registry Report

  The 2024 IRIS^® Registry Industry Report showcases the transformative power of real-world data (RWD) in ophthalmology.

• Richter BioLogics Drives Efficiency And Compliance With Unified Quality

  Learn how one CDMO tripled production, improved audit readiness, and built customer trust by unifying quality systems and embracing a digital-first approach.

• EHR-To-EDC Success In A Complex, Adaptive Platform Trial

  I-SPY 2, one of the longest-running adaptive platform trials in oncology, is revolutionizing breast cancer research through a dynamic, data-driven approach to evaluating novel therapies.

• 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.

• Flexible Integrations To Reduce Risks And Increase Efficiencies

  Learn how a trial team kept the blind of central lab samples and patient treatment across a Phase III and extension trial, whilst optimizing the supply chain.

• Digital Standardization: Accelerating Gene Therapy Tech Transfer With Confidence And Compliance

  Fragmented, manual data practices slow tech transfer and increase risk; centralized digital CMC systems standardize workflows, improve transparency, and accelerate onboarding while maintaining compliance.