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WHITE PAPERS AND CASE STUDIES

• Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy

  Hereditary transthyretin amyloidosis (ATTRv) is very rare, prompting a Phase 1 trial of in vivo CRISPR/Cas9 gene editing to reduce mutant protein and stop cardiomyopathy progression.

• 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.

• How To Get Products To Patients Faster With A Connected QMS

  BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.

• Compliance Auditing: Diving Into Common Critical Findings

  Review critical findings in compliance audits, highlighting frequent issues, their impact on operations, and steps companies can take to improve regulatory compliance.

• 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.

• HOT SWIR Detector Technology For Both Passive And Active Imaging Applications

  Collins Aerospace Princeton advances SWIR photodetector arrays with innovations in dark current reduction, hybridization, avalanche photodiodes, and fabrication processes for improved performance.

• Evaluating Milling Conditions For Scaling Up A Nanosuspension Drug Product

  Aiming to obtain a target particle size to support Phase 3 clinical trials, uncover how this study contributed insights on nanosuspension drug product production at escalated scales.

• Physiologix™ Serum Replacement Performance On Mesenchymal Stem Cells

  Learn about the effectiveness of a xeno-free serum replacement in mesenchymal stem cell (MSC) culture and its potential to enhance cell growth and reduce variability compared to fetal bovine serum.

• BioIVT Collaborates With IDBS To Deploy IDBS E-WorkBook And Reduce Study Cycle Times

  Learn about a collaboration that has enabled BioIVT to enhance efficiency and responsiveness to its biopharmaceutical clients.

• Symmetry Surgical Uses Software To Enhance Quality

  Symmetry Surgical enhances operations and quality management using software to improve efficiency, compliance, and data-driven decisions while producing over 2 million surgical devices annually.

• Leveraging The Immunological Diversity Of The Pentamice® Platform For Covid-19 Antibody Discovery

  Consider this alternative immunization approach — the PentaMice platform, a collection of five wildtype mouse strains bred in-house for increased MHC class II diversity — and how we're leveraging it for COVID-19 antibody discovery.

• Owen Mumford Slashes Audit Findings, CAPAs, And NCRs

  Gain insights into how Owen Mumford, a global medical device leader, enhanced their compliance and efficiency with software to reduce audit findings and improve quality management.