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WHITE PAPERS AND CASE STUDIES

• Organizational Assessment For A Large MedTech Company

  Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.

• Mobile Gowning Cleanroom, Built To Meet ISO 7 Requirements

  Uncover how Germfree designed and installed a mobile cGMP cleanroom on a 53′ tractor-trailer chassis to provide a flexible and efficient cleanroom solution tailored to the company’s needs.

• Full Scale Operations For Parenteral Pharmaceuticals

  Explore how a project team accelerated through milestones in development, approval and execution of Equipment Evaluations, Equipment Specification Documents, Installation Qualification, and Operational Qualifications.

• Pasteurized Equivalent Water Treatment At Tnuva Ba'Emek, Israel

  In the heart of Israel’s Jezreel Valley, Ba’emek Advanced Technologies—part of the Tnuva Group—faced a critical challenge: how to sustainably reuse water extracted from whey during dairy processing without compromising safety or quality.

• A Feeder-Free Platform For Generating Mature Natural Killer Cells

  NK cells represent a promising avenue for immunotherapy. Examine the advantages of NK cells in cellular immunotherapy and the importance of developing efficient activation and expansion platforms.

• Top Biopharma Enhances Regulatory Efficiency

  Learn how this biopharma company was able to assemble project teams focused on implementing real-time document transfer for central IRB documentation and communications, significantly reducing errors and improving data management.

• Alerion Microbubble Cell Separation System Used For T Cell Negative Selection

  Discover how the Alerion™ Microbubble Cell Separation System outperformed standard magnetic methods in T cell recovery, speed, and scalability — achieving higher cell quality with Akadeum’s innovative microbubble technology.

• A Review Of The Changing Trends And Use Of eCOA In Clinical Trials

  Delve into how electronic clinical outcome assessments are being transformed through new technologies, the maturation of digital organizations, and increased endorsement from regulatory bodies.

• Pasteurized Equivalent Water Treatment At High Desert Milk, Idaho, US

  Learn how High Desert Milk, a cooperative in Idaho, optimized their water treatment process using HOD™ UV technology, ensuring FDA compliance while significantly reducing water and energy consumption.

• How Early-Stage Planning Strategies Are Optimizing Drug Development

  Early integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact.

• Mobilizing Compliance: USP 797 And 800 Pharmacy Trailer Fleet For VA Hospitals

  VA hospitals across the US are undergoing renovations to bring their facilities into compliance. The challenge was to design and manufacture a fleet of self-sufficient mobile compounding pharmacies.

• Achieving Faster Timelines And Cost Savings Through Digital Validation

  Examine how the Project Ready program was leveraged to streamline validation processes for a CDMO, resulting in a 25% reduction in budget and faster project completion.