Document Migration

WHITE PAPERS AND CASE STUDIES

• Buffers And Process Liquids For Biopharmaceutical Production: Considerations For Scale-Up And Outsourcing

  For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce regulatory risk.

• Electronic Batch Reporting

  Learn how a CDMO automatically created a comprehensive batch report model to drive their reporting and speed root cause identification of quality failures with an Industrial DataOps software solution.

• 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.

• 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.

• The Advantages Of A Blended Learning Approach In Operator Training

  Explore blended learning and its advantages over traditional operator training methods, which often reduce training to a repetitive but necessary checklist of reading and acknowledging procedures.

• Antibody-Drug Conjugates – Catalysts For Chemistry

  Review the complexities of developing linkers – chemical moieties which attach a drug payload to an antibody – and considerations when identifying a CRO for ADC research and development.

• How Bend Bioscience Standardized Operations And Boosted Compliance

  Discover how Bend Bioscience replaced its outdated CMMS with RAM to achieve rapid compliance, boost efficiency across facilities, and cut operational costs by 25%.

• 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.

• 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.

• CHA Consulting Is Helping Florida Utilities Meet Ambitious Reclaimed Water Effluent Regulations

  Discover how CHA Consulting has been working to help utilities across the sunshine state find the right balance and stay ahead of statewide deadlines for compliance.

• Digitalizing Batch Records In Pharmaceutical Production

  Pharma manufacturing embraces cutting-edge automation, yet outdated paper-based documentation hinders efficiency and delays batch releases. See how digital solutions can transform compliance.

• Providing Enhanced Manufacturing Data To Contracting Companies

  The life sciences sector is projected to reach $220 billion by 2030. Examine the growth of CDMOs and CMOs, emphasizing the need for digitalization to meet client demands and regulatory standards.