High-Volume Scanners

WHITE PAPERS AND CASE STUDIES

• Overcoming HCP Co-Elution Issues Using Cell Line Engineering

  Product quality assessments revealed that a customer’s therapeutic protein had a range of hydrophobic HCPs. Review a solution that took an alternative approach by utilizing cell line engineering.

• 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.

• Precision Project Management In Action

  Discover how a tailored, risk-based project management approach was used to overcome the challenges of a complex Phase I/IIa FIH multi-country study of an advanced therapy medicinal product (ATMP).

• Accelerating Cold Chain Expansion: Responding To COVID-19 Challenges

  Review how leveraging cross-functional teamwork helped complete a cold chain infrastructure expansion in a fraction of the expected timeline, ensuring the production of essential COVID-19 therapeutics.

• Transforming Clinical Trial Sites With Research Study Rockstar

  This innovative platform streamlines workflows, automates patient communication, and provides intuitive dashboards to address prevalent pain points faced by trial coordinators.

• Achieving Licensing For A Healthcare Solution

  Facing strict regulations and tricky powders, a healthcare client sought an advanced filling solution. Learn how an expert collaboration led to licensed product, boosting precision and productivity.

• 3-Week Database Builds That Withstood FDA Review

  Learn how a lean clinical team deployed global, regulator-ready databases in just three weeks to secure immediate Phase 3 entry and transform reproductive health research.

• Simplify CAPA In 7 Steps

  Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

• Writing An IND Module 3 For Cell And Gene Therapy Products

  This whitepaper outlines the critical considerations for CGT Investigational New Drug (IND) Module 3, as well as how to avoid clinical holds and ensure regulatory readiness.

• Advancing Multiomics Through Intelligent Automation

  Modern automation tackles hidden pipetting errors and boosts reproducibility. Discover how your lab can scale confidently, reduce rework, and accelerate multiomic workflows with built-in traceability.

• Improving Methodologies For iPSC Manufacturing And Differentiation

  Learn how next-generation workflows are being developed to streamline iPSC manufacturing, enhance differentiation strategies, and overcome the hurdles of scalability and consistency.

• Mobile Advanced Therapies Facility

  Discover NIH's innovative solution to clinical-stage viral vector production: See how two mobile cGMP facilities deliver adaptability and compliance to Bethesda's National Institute of Health.