High-Volume Scanners

WHITE PAPERS AND CASE STUDIES

• Navigating Regulatory Compliance In Medical Device Development For Prefilled Syringes And Auto-Injectors

  Developing prefilled syringes and auto-injectors requires rigorous mechanical, user-focused, and compliance testing to ensure device safety, effectiveness, and seamless regulatory approval for patient use.

• How Early-Stage Planning Strategies Are Optimizing Drug Development

  Early integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact.

• Leveraging High-Pressure Sterile Filtration For Highly Viscous Solutions

  This research demonstrates the potential of high-pressure sterile filtration to enhance efficiency, reduce waste, and accelerate the development of innovative therapies.

• The True ROI Of Decentralized Clinical Trials

  Gain a greater understanding of how the right DCT solution, or combination of solutions, coupled with clear metrics and expert guidance on execution, can demonstrate tangible, quantitative ROI in clinical trials.

• How Digital Transformation In Sample Management Increases Efficiency

  Explore a real-world example of how a dynamic and growing CDMO implemented a lab management system to improve efficiency and data integrity for their quality control sample management workflows.

• Reducing ADC Timelines With Integrated Development And Manufacturing

  ADCs have proven to be highly effective in cancer treatment, but their manufacturing poses challenges. Learn how a CDMO partner can help bring these treatments to patients safely and efficiently.

• How eSource Reduced Benchmark's Protocol Deviations By Almost 40%

  Explore how a leading vaccine site network selected CRIO to help address the challenges with it's use of paper charts in collecting source data.

• 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.

• ProPharma Supports A Contract Manufacturer's Form 483 Response

  Learn how a small contract manufacturer navigated a complex FDA 483 Observation notice and implemented effective remediation strategies that addressed multiple system-wide concerns.

• 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.

• Process Scale Column Packing Instructions

  Explore a comprehensive guide to using DurA Cycle A50, a high-capacity, alkaline stable protein A affinity chromatography resin for the downstream processing of mAbs and recombinant proteins.

• Achieve Higher Targeted Concentrations

  Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.