Healthcare

WHITE PAPERS AND CASE STUDIES

• Earning RMAT Designation - What Developers Need To Know

  Explore a high-level overview of the Regenerative Medicine Advanced Therapy designation and how to ensure success and accelerate advanced therapy products toward commercialization.

• CHO Cell Lines For Recombinant Protein Production

  Discover how new strategies in CHO cell line development are driving innovation and transforming the future of biologics manufacturing, from enhanced productivity to improved therapeutic quality.

• Handle Single-Use Technology Biopharma Waste: Data Sharing, Collaboration

  Learn more about data sharing and collaboration to enable a better environmental impact of single-use technologies (SUTs) and quantifying the single-use plastic waste generated when manufacturing mAbs.

• Developing Effective Procedures

  Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

• How A Leading CDMO Reduced Yield Variability With Automation

  Explore the transformative journey of a leading CDMO company and how they adopted an innovative platform that enhances data analytics and drives pharmaceutical manufacturing advancements.

• Increase Production Capacity With Virtualized Process Automation

  Learn how Sleeman Breweries grew their production, improved process control, and avoided the high expense of building a new greenfield facility.

• Best Practices For Sterilization Validation In Medical Device Manufacturing

  Sterilization validation ensures medical device safety by confirming sterility through rigorous testing, method selection, and regulatory compliance, using both established and emerging sterilization technologies.

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

• Modernizing Operational Maintenance At Treatment Plants

  In 2017, the Harford County Division of Water and Sewer began looking for a modern work management solution to help automate preventive maintenance, coordinate work activities between groups, manage material inventories, and capture important data.

• Mobile App And Wearable Integration Collects Longitudinal Data

  Get an overview of SISCAPA's utilization of eTechnologies, specifically ePRO, and how their partnership with CDS accurately demonstrates the improvement of data collection and analysis in the biotechnology industry.

• 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.

• 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.