Business Process Management

WHITE PAPERS AND CASE STUDIES

• Streamlining AAV And LVV Manufacturing Platform Solutions

  Observe how streamlined, scalable platforms are transforming viral vector manufacturing to accelerate the delivery of cell and gene therapies to patients.

• Unravelling The Complexities Of ADC Manufacturing

  Whether you're in the early stages of development or scaling up for commercialization, understanding ADC manufacturing challenges is essential for bringing life-saving therapies to patients worldwide.

• CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics

  CDMOs must innovate production architectures to meet the demands of advanced therapeutics to ensure a reliable supply and compliance. Discover how these approaches advance modern medicine and improve patient outcomes.

• 8 Ways To Achieve Higher ROI In Quality

  Is your company still using outdated methods for its QMS? It's time to evolve. Uncover how an integrated QMS can streamline operations, enhance compliance, and support your company's growth.

• Retention Begins With Recruiting The Right-Fit Patients

  Recruiting the right patients into a clinical trial is only half the battle. To combat attrition, sponsors must also institute measures that ensure patients remain comfortable and confident throughout the trial.

• 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.

• 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.

• Re-Engineering A Complex Process For FDA Compliance

  Discover the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance.

• Blending Tradition And Technology For A Water-Resilient Future

  Discover how a desert utility is evolving its operations to safeguard Tucson’s water supply for generations to come.

• Perspectives On Performance, Scalability, And Regulatory Compliance

  Here, we discuss the challenges and solutions for cell and gene therapies, focusing on performance, scalability, and regulatory compliance to accelerate commercialization and improve patient access.

• Meeting The FDA's CAPA Expectations

  Year after year, deficiencies in corrective and preventative action procedures have consistently topped the list of the most common observations during FDA inspections. Gain insight on how to ensure your organization is CAPA-ready.

• Automated Validation And Centralized Data

  Discover how intelligent CPV, powered by automation and real-time analytics, is transforming manufacturing by driving quality, compliance, and innovation in a rapidly evolving regulatory landscape.