Business Process Management

WHITE PAPERS AND CASE STUDIES

• How Vanguard Clinical Harnesses CDMS/EDC For Faster Results

  Uncover how this CRO was able to stay agile by choosing a CDMS/EDC partner that prioritized sponsor needs and streamlined operations to achieve top-tier results swiftly.

• Preparing The Next Generation Of Clinical Research Professionals

  Explore the live EDC platform that enabled Durham Tech to create a model for future-forward, hands-on education in clinical research.

• Understanding Biosafety Levels

  Compliance with biosafety levels (BSLs) is crucial in ensuring that your laboratories meet stringent standards to protect staff and prevent the escape of biological agents.

• 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.

• Reframing Clinical Vendor Selection

  Explore a platform that enables seamless vendor selection as well as cross-functional collaboration with built-in templates and tailored question libraries that simplify proposal creation and review.

• Digital Transformation Optimizes Production, Quality, And Compliance

  Discover how advanced automation solutions at Fermion's new facility were implemented to enhance production, quality, and compliance in pharmaceutical manufacturing while meeting industry standards.

• Redefining The Analytical Frameworks Surrounding Capsid Characterization

  Modern AAV manufacturing demands precise capsid characterization to distinguish empty, partial, and full particles, as regulators now require rigorous purity and potency control for clinical safety.

• Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes

  The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.

• Comparing Process Development Approaches For Recombinant Proteins

  Explore how adding a traceless tag enables streamlined affinity purification for recombinant proteins, and how this approach compares with a conventional process in development time, recovery, and purity.

• Development Strategies For Adenovirus-Based Gene Therapies

  Scaling up viral vector production can be challenging, and ensuring consistent titers and activity requires careful optimization and technical expertise.

• Operational Success By Strategic Investment

  Explore how infrastructure, equipment strategy, and advanced technologies shape a more reliable path for scaling sterile injectable programs.

• The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics

  Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.