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WHITE PAPERS AND CASE STUDIES

• Live Biotherapeutic Products: Unique Quality, Manufacturing, And Nonclinical Considerations For Clinical Trial Entry

  Live biotherapeutic products (LBPs) represent an emerging frontier in therapeutic development, harnessing living microorganisms to prevent, treat, or cure disease.

• 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.

• From Problem To Performance: A Custom Filter That Transformed Imaging Quality

  IDEX Health & Science solved a multi-band fluorescence imaging challenge by designing Semrock filters with ultra-deep blocking, steep edges, and wider passbands for exceptional image quality.

• UV Disinfection And Dechlorination At Cottonseed Processing Facility In Texas, US

  The Archer Daniels Midland Company (ADM) requires full-scale nonchemical disinfection and dechlorination treatment of RO feedwater to the boiler which supports their cottonseed processing facility in Lubbock, Texas.

• Reducing Complexity In Data Center Cooling Temperature Measurements

  Endress+Hauser’s iTHERM SurfaceLine TM611 non-invasive temperature measurement performs comparably to traditional industrial thermometers with an elegant mechanical innovation.

• Aseptic Filling Solution Enhances Sterility Assurance for Pharma Manufacturer

  Emergent BioSolutions upgraded its Winnipeg site with the Cytiva SA25 aseptic filling workcell to improve sterility assurance, product flexibility, and regulatory compliance for CGT manufacturing.

• Pharma Custom Isolator For Sterile Lab Process

  This project showcases Germfree’s capacity to provide cutting-edge, bespoke solutions in pharmaceutical manufacturing, underpinning their dedication to innovation, safety, and quality.

• 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.

• Expand Bandwidth With A Trusted Regulatory Writing Partner

  Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.

• Collaborative Variability Reduction In Cell Culture Media

  Variability reduction programs improve biomanufacturing by controlling raw‑material complexity, optimizing critical attributes, and boosting productivity through data‑driven partnerships.

• Quality By Design: Better Data Using Participant Insights

  While clinical trials will always encounter challenges in driving quality experiences and data, there is one approach that’s backed by regulatory agencies and proven to lead to better outcomes.

• Vial Fogging: Practical Considerations For Vial Selection

  Vial fogging is a common phenomenon observed in lyophilized biologic drug products. This document presents two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.