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WHITE PAPERS AND CASE STUDIES

• 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).

• Challenges And Solutions In Lyophilization Development For ADCs

  Successful ADC lyophilization requires a robust, individualized process driven by thermal characterization using DSC and FDM to define the critical parameters for stability and efficient manufacturing.

• Is Sustainability The Key To Agile Biopharma Manufacturing?

  In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.

• Elevating mRNA Manufacturing Toward GMP-Readiness

  The mRNA Technology Transfer Program empowers LMICs with scalable vaccine production. Learn about a partnership that drives innovation in mRNA and sets a global blueprint for equitable health access.

• Enhancing Viral Clearance Prediction And Process Optimization

  MockV® technology enables early, in-house viral clearance assessment, helping biopharma developers improve process robustness, reduce costs, and enhance safety before GMP manufacturing begins.

• Pharmacokinetic Study Of Salbutamol Through Nose Only Exposure In CD-1 Male Mice

  Explore how using advanced tools like the inExpose system can provide precise measurements of lung and plasma drug concentrations to optimize inhalation therapy for pulmonary treatments.

• Physiologix Serum Replacement Performance On T Cells

  A serum replacement for promoting T cell growth and functionality in cell therapy development shows comparable or superior performance to traditional human serum supplements.

• Extractables And Leachables Assessment For Single-Use Systems

  Efforts to enhance biopharmaceutical manufacturing focus on boosting production capacity sustainably and economically. Explore how optimizing processes with single-use solutions and monitoring leachables ensures product quality.

• Simplifying The Transition To Multi-Column Chromatography

  Explore the advantages of multi-column chromatography and how to transfer your process from batch to an intensified system, step-by-step.

• Achieving Excellence In Clinical Research And Quality Management

  Lotus Clinical Research, founded in 2001, leverages regulatory expertise and digitalization to enhance quality, automate processes, and improve compliance in biopharmaceutical clinical trials.

• Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning

  The piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.

• 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.