Document Migration

WHITE PAPERS AND CASE STUDIES

• Non-Viral Genetic Modification Using The 4D-Nucleofector LV Unit In CGT

  This paper underscores the 4D-Nucleofector® LV Unit as a pivotal tool for translating genetic modification technologies into scalable, safe, and effective therapeutic solutions.

• How To Adopt CSA For Streamlined Computer System Validation

  Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

• Biometric Services For Large Pharmaceutical Company

  This case exemplifies the effectiveness of flexible staffing solutions in meeting the dynamic needs of the biopharmaceutical industry while maintaining control over project deliverables and timelines.

• 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.

• Reducing Costs & Risks: A Pharma Guide To FTZ Subzones For U.S. Drug Manufacturing

  Utilized wisely, FTZs and subzones can be tools for cost savings and can enable pharma companies to leverage the benefits of American manufacturing.

• Reducing Lead Time, Delivering >99.5% OTIF

  Explore the stocking solution offered to a mid-sized CDMO in need of a high volume of safety stock inventory to support their customer portfolio growth.

• 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.

• Revolution In The EU Pharmaceutical Legislation Ahead

  Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.

• 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.

• A Risk-Based Approach To Plasmid DNA And mRNA Process Development

  Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.

• Biopharma Production And Quality Control With Electrophoresis

  Discover how Kaneka Eurogentec, a leading provider of custom DNA synthesis and molecular biology services, enhanced their fragment analysis to achieve higher efficiency and accuracy in their workflows.

• Compliance Auditing: Diving Into Common Critical Findings

  Review critical findings in compliance audits, highlighting frequent issues, their impact on operations, and steps companies can take to improve regulatory compliance.