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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.

• Successful Cell-Based ADA Collaboration In mRNA Gene Replacement Therapy

  A biotech firm developed a rapid, sensitive, cell-based ADA assay through collaborative innovation, reducing variability and turnaround time while improving performance for mRNA gene therapy.

• 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.

• Richter BioLogics Drives Efficiency And Compliance With Unified Quality

  Learn how one CDMO tripled production, improved audit readiness, and built customer trust by unifying quality systems and embracing a digital-first approach.

• 8 Ways To Achieve Higher ROI In Quality

  Is your company still using outdated methods for its QMS? It's time to evolve. Uncover how an integrated QMS can streamline operations, enhance compliance, and support your company's growth.

• Measuring The Energy Of One Of The Most Powerful Lasers In The USA

  Gentec-EO supported a high-power laser research center with custom detectors and calorimeters, enabling precise energy measurements critical for advancing groundbreaking physics.

• Eliminate Clinical Trial White Space With The Right AI Strategy

  Learn how sponsors and CROs are using agentic AI to eliminate the unproductive time caused by manual, sequential processes and fragmented data systems.

• Robust, Scalable Strategy For Monodisperse Nanosuspensions Of Poorly Soluble Drugs

  By tailoring the formulation strategy, selecting the appropriate excipients, and fine-tuning process conditions, see how our team was able to improve bioavailability and in vivo exposure.

• Efficient Carbon And Ion Exchange Media Exchange

  This document outlines the essential steps required to exchange spent media, including disposal of spent media.

• Generation Of A Contamination Control Strategy

  An unaddressed compliance issue related to contamination control can pose a significant risk to a life sciences organization. This case study details a company's journey toward sustainable compliance.

• Overcoming HCP Co-Elution Issues Using Cell Line Engineering

  Product quality assessments revealed that a customer’s therapeutic protein had a range of hydrophobic HCPs. Review a solution that took an alternative approach by utilizing cell line engineering.

• Molecular Properties Of PROTACs And The Relationship To Formulation Design

  Here, we conduct a comprehensive analysis of diverse PROTAC (Proteolysis Targeting Chimeras) structures, evaluating their calculated physicochemical properties to identify key trends.