Healthcare

WHITE PAPERS AND CASE STUDIES

• Understanding Real-World Patient Characterization And Safety Outcomes Of DEXTENZA

  In this study, we can derive confirmation of DEXTENZA’s favorable safety profile across a broader surgical spectrum.

• Leveraging Single-Use Solutions To Solve Working Cell Bank Challenges

  Discover how custom manifolds enhance allogeneic therapy development from formulation to commercialization by improving process control, scalability, and efficiency.

• 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.

• OPTICHECK Technology Built-In – Diagnostics, Verification, And Functional Safety With OPTIMASS Coriolis Mass Flow Meters

  State-of-the-art measuring devices such as OPTIMASS Coriolis mass flow meters combine robust measuring principles and powerful electronics to produce a wide range of readings and device-specific data. OPTICHECK technology built-in leverages the features of the devices to translate their available comprehensive measuring system data into sophisticated diagnostics information for plant personnel. 

• Democratize Batch Data Management For AAV Gene Therapies

  Explore a biotechnology company's process of choosing a data management solution that offered centralized batch data management, allowing the company to streamline its CMO data delivery process.

• 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.

• Best Practices For Sterilization Validation In Medical Device Manufacturing

  Sterilization validation ensures medical device safety by confirming sterility through rigorous testing, method selection, and regulatory compliance, using both established and emerging sterilization technologies.

• Aseptic Process Design And Simulation Under Annex 1 Guidelines

  Gain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.

• EHR-To-EDC Success In A Complex, Adaptive Platform Trial

  I-SPY 2, one of the longest-running adaptive platform trials in oncology, is revolutionizing breast cancer research through a dynamic, data-driven approach to evaluating novel therapies.

• Challenges In Developing Medical Devices From Animal-Based Biomaterials In China

  Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

• How To Recruit 236 Patients In An Osteoarthritis Study On Time During The Peak Of The Pandemic

  A leading Eastern European contract research organization completed the recruitment of 236 subjects in a Phase 3 osteoarthritis study for Handok Inc. despite hurdles caused by the COVID-19 pandemic.

• Revolutionizing Lentiviral Vector Manufacturing For In Vivo, Ex Vivo CAR-T Therapies

  Discover how scalable, cost-effective, and high-quality lentiviral vector manufacturing can accelerate both ex vivo and emerging in vivo CAR-T therapies.