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WHITE PAPERS AND CASE STUDIES

• Accelerating Approval Pathway For Phase III Ovarian Cancer Trial

  A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.

• A Synergy Of Excellence: Partnership During Unprecedented Times

  Learn how a partner with the right experience and capabilities is crucial to support accelerated GMP manufacturing and ensure novel vaccines and therapeutics receive regulatory approval.

• Achieving Excellence In Clinical Research And Quality Management

  Lotus Clinical Research, founded in 2001, leverages regulatory expertise and digitalization to enhance quality, automate processes, and improve compliance in biopharmaceutical clinical trials.

• 3D Scanning System Brings Digital Characters To Life

  Explore how advancements in visual effects, driven by high-speed 3D digital capture systems from Pixel Light Effects, are transforming the entertainment industry.

• Achieve Higher Targeted Concentrations

  Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

• Proprietary Reactivation Study Demonstrates PFAS Removal And Destruction Expertise

  Thermal reactivation of granular activated carbon is a proven and scalable method to achieve >99.9% destruction removal efficiency for PFAS. This process fully restores the carbon for reuse, providing a sustainable solution that breaks the cycle of "forever chemicals."

• Apavital S.A. Digitalizes Water Consumption With Itron's Smart Metering Devices

  Modernize water network management by combining precision ultrasonic metering with advanced acoustic leak detection. This integrated digital approach provides real-time data to identify vulnerabilities, minimize non-revenue water, and optimize distribution for long-term operational sustainability.

• A Decade Of Smart Water Success — The Eastern Band Of The Cherokee Indians

  What began as a mandate to reduce water loss has grown into a model of smart water management for the Eastern Band of the Cherokee Indians (EBCI). Since deploying Kamstrup’s ultrasonic meters in 2016, the utility has transitioned from crisis response to innovation leadership—proving that even the most rugged terrain can support advanced metering infrastructure (AMI).

• Design Testing Strategies To Develop A Drug-Device Combination Product

  Leveraging the expertise and experience of a trusted partner can reduce risk and accelerate the time to market for drug-device combination products by creating an optimal Validation Master Plan.

• Process Development For Lyophilized Products

  Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.

• Tailored ISO 5 RABs Unit To Protect AST's Patented Filling Machine

  Uncover how AST's satisfaction with Germfree's solution led to the acquisition of two additional units, showcasing the project's success and Germfree's expertise in tailored cleanroom solutions.