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WHITE PAPERS AND CASE STUDIES

• BSL-3 Mobile Biocontainment Laboratory For Vaccine Development Research

  The client required a freestanding COVID-19 research facility on an accelerated timeline built for continuous use in the cold climate of the northeast United States without a shell building.

• Scalable Production Of High-Purity Nanobodies Using Yeast Expression System

  Leverage scalable K. pastoris expression systems to produce high-quality nanobodies for cutting-edge therapeutic, diagnostic, and research applications.

• Formulation Development Of Enterically Protected Spray Dried Dispersions

  Adrulipase spray-dried dispersions were evaluated to create an orally delivered, enteric-protected enzyme. The lead formulation provided the best acid protection, rapid release, and stability.

• Overcoming The Top 3 Challenges In Setting Up And Managing Clinical Trials

  Navigating the intricacies of clinical trials demands adept handling of document management, regulatory compliance, and financial forecasting. Learn key strategies for overcoming these hurdles.

• Writing An IND Module 3 For Cell And Gene Therapy Products

  This whitepaper outlines the critical considerations for CGT Investigational New Drug (IND) Module 3, as well as how to avoid clinical holds and ensure regulatory readiness.

• 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.

• Optimizing Upstream Process Development To Increase mAb Titers

  Uncover how we were able to help a client develop an efficient upstream process for a novel monoclonal antibody (mAb), resulting in a more than 100% increase in titers.

• 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.

• 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.

• Modifying The Micro-Environment To Improve Dissolution Rate

  Discover how modifying the micro-environment with targeted excipients can significantly enhance the dissolution rate of poorly soluble drugs using conventional manufacturing methods.

• Sensing Beyond Limits: Transforming User Experience With UWB Radar

  Ultra-Wideband radar sensing enables low-power, high-precision presence, motion, and vital-sign detection, unlocking smarter automotive, smart-home, and healthcare applications beyond traditional ranging.

• Custom Microscope Objective Case Study

  Melles Griot custom objectives deliver superior imaging, color correction, and system repeatability—tailored for demanding applications where standard microscope optics fall short.