Business Process Management

WHITE PAPERS AND CASE STUDIES

• 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.

• The Impact Of Artificial Intelligence On CQV

  AI is revolutionizing CQV in life sciences by automating documentation, enabling real-time monitoring, and driving predictive quality to boost efficiency and compliance across validation processes.

• 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.

• Newport News, VA Deploys 130,000 Mueller AMI Meters

  Eight years ago, Newport News started having discussions about moving away from reading their mechanical, manually read meters every other month to go to monthly billing. Knowing they did not have adequate staffing to handle that task, the department decided to outsource its meter reading responsibilities to a third party. 

• Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer

  Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.

• Why Early Market Access Planning Is Crucial In CGT Commercial Strategy

  Bringing cell and gene therapies (CGTs) to market and ensuring patient access is a complex process. Discover how developing a market access strategy and partnering with experts can help.

• 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.

• Enhancing Preclinical Cell Therapy Development

  Automation in cell therapy development boosts reproducibility, reduces error, and enhances yield. Learn how it’s reshaping preclinical workflows and accelerating clinical trial readiness.

• Predictive Modeling Of Transmitted Wavefront Error In High-Performance Optical Coatings

  When interferometric testing isn’t possible, an analytical, spectral-based model predicts coating-contributed transmitted wavefront error with confidence, enabling compliance and control for advanced optical systems.

• Accelerating The Development And Production Of High-Quality bsAbs

  Bispecific antibodies (bsAbs) are revolutionizing medicine by targeting two disease mechanisms simultaneously. Learn about an innovative platform offering excellent pairing and enhanced productivity.

• Phase 1 Clinical Trial Designs And Strategies

  With tailored guidance, sponsors can align their modern model-based and model-assisted design choices to program goals, accelerating progress while safeguarding patients.

• Five Essentials For Accurate Oligonucleotide Chemistry

  Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.