Document Migration

WHITE PAPERS AND CASE STUDIES

• 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.

• ICH E6(R3) In Effect: Transforming Quality Management For CGT Trials

  Discover how the updated ICH E6(R3) guideline supports the speed and complexity of CGT manufacturing, enabling flexible, risk‑based decisions and quality systems built to scale therapies safely.

• Increasing Batch Size And Reducing Cycle Times For A Biologic

  JHS partnered with a global pharma company to optimize biologic production, increasing output by 50% and reducing batch release times by up to 30%.

• 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.

• Leading European CDMO For Drug Product Manufacturing

  As timelines tighten and regulatory demands grow, discover how a European CDMO delivers integrated solutions from aseptic fill and finish to packaging and release.

• Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility

  The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.

• Transforming Environmental Monitoring And Sample Management

  Discover how applying an OpEx framework to environmental monitoring and sample management can optimize workflows, improve resource utilization, and deliver measurable annual cost savings.

• Preparing CRAs For Success In Oncology: Targeted Training In An Era Of Advanced Therapeutics

  Explore the pivotal role of Clinical Research Associates (CRAs) in oncology clinical trials, emphasizing their critical responsibilities and the importance of specialized CRA training programs.

• Richter BioLogics Drives Efficiency And Compliance With Unified Quality

  Learn how one CDMO tripled production, improved audit readiness, and built customer trust by unifying quality systems and embracing a digital-first approach.

• 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.

• Process Development For Lyophilized Products

  Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.

• Validation Provider Shortens The Path To Equipment Qualification

  Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.