Records Management

WHITE PAPERS AND CASE STUDIES

• Key Considerations For Selecting A Solenoid Valve In Health & Science Applications

  Solenoid valves are vital in medical devices, enabling precise fluid and gas control. Explore customizable, high-reliability valves that optimize performance while conserving space, weight, and power.

• 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.

• Monitoring Laser Power In Laser-Based Fill & Finish Biopharmaceutical Systems

  Custom laser power measurement ensures precise vaccine vial sealing, meeting strict biopharma compliance standards through tailored detectors, firmware, and calibration for critical fill-finish applications.

• 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.

• Decoding A B-Cell Fingerprint: All You Need To Know

  Explore how, much like a fingerprint, each B-cell possesses a unique identity, and how deciphering this code can unlock a wealth of possibilities in antibody development, immunotherapy, and beyond.

• Disinfection For Purified Water Loop For Kamada Pharmaceuticals, Israel

  An Atlantium HOD™ (Hydro-Optic Disinfection) UV system was installed at the outlet of a PW tank to serve as the primary disinfection barrier, with water circulating through the system at 6m³/hr before reaching the points of use.

• 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.

• Getting More From Your Buffer Management Strategy

  A drug manufacturer was facing challenges in buffer management. By implementing innovative inline buffer formulation technology, they were able to save space, increase efficiency, and become more sustainable.

• Achieving Licensing For A Healthcare Solution

  Facing strict regulations and tricky powders, a healthcare client sought an advanced filling solution. Learn how an expert collaboration led to licensed product, boosting precision and productivity.

• Selecting A New Sporicidal Disinfectant: What The Cleanroom Manager Needs To Know

  This guide helps cleanroom managers evaluate sporicides by efficacy, safety, and compatibility to ensure contamination control without compromising operational integrity.

• Preparing For Disease X: Effective Vaccine Development In The Face Of A Future Pandemic

  CDMOs are playing a critical role in the global effort to prepare for future pandemics. Learn how innovative strategies and flexible platforms are helping to ensure a swift and effective response plan.

• Streamline Your mAb Manufacturing With Strategic Development And CDMO Compatibility

  Though the journey to mAb development begins at lab scale, for clinical trials and commercial distribution, a production process must be streamlined and scalable to 2,000 L production and above.