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WHITE PAPERS AND CASE STUDIES

• 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.

• Modernizing Clinical Trial Logistics To Deliver Value

  Explore how biopharma organizations can design and operate clinical supply systems that absorb complexity while maintaining control and consistency.

• Master Protocols: Implementing Effective Treatment Adaptations

  From balancing treatment ratios and managing eligibility to accommodating site-specific readiness and protocol amendments, a well-designed IRT system enables seamless transitions.

• How Sharp Packaging's Clinical Packaging Process Is 30% Faster

  Discover how digitized workflows and real-time verification are helping streamline clinical trial packaging, reduce complexity, and improve quality in a high-stakes, time-sensitive environment.

• Meet Regulation Requirements With RTU Vials And Cartridges

  Sterile manufacturing remains vital, with resilient supply chains preventing shortages. Industry and regulators prioritize integrity as demand surges, making it the fastest-growing pharmaceutical segment.

• From CLD To CDMO: Demonstrating A Successful Cell Line Technology Transfer

  Explore critical considerations for biopharmaceutical developers and CDMOs during technology transfer as well as a successful transfer and scale-up of a cell line from a CLD platform to a global CDMO.

• 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.

• The Smart Industry Readiness Index: A Path To Achieving Digital Maturity

  In a time defined by the Fourth Industrial Revolution (Industry 4.0), a period transforming industries through advanced technologies, the manufacturing landscape is evolving beyond something we recognize as familiar. With the potential to automate processes, enhance data visibility, optimize operations, and redefine value chains, technology is revolutionizing industries across the globe. However, many organizations grapple with a critical question: How can they assess their digital transformation (DX) readiness for this most important paradigm shift?

• Accelerating Antibody-Drug Conjugate (ADC) Development

  Explore how automated immunoassays help overcome ADC bioanalysis challenges, reducing hands-on time, improving throughput, and enabling multi-analyte workflows for more efficient assessments.

• Life Sciences Corporation Implements eLogbooks Across 15 Sites

  New regulations challenged how surgical kits were tracked and processed across 15 U.S. sites. Discover how one team balanced compliance and efficiency to keep life-saving procedures on schedule.

• Driving Customer Profitability With Enterprise Platform, Pricing

  Explore how the solutions and approaches offered by CDS can help different research stakeholders conduct more cost-efficient clinical trials in the industry's pharmaceutical, biotech, and device sectors.

• Vial Fogging: Practical Considerations For Vial Selection

  Vial fogging is a common phenomenon observed in lyophilized biologic drug products. This document presents two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.