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WHITE PAPERS AND CASE STUDIES

• ProPharma Supports A Contract Manufacturer's Form 483 Response

  Learn how a small contract manufacturer navigated a complex FDA 483 Observation notice and implemented effective remediation strategies that addressed multiple system-wide concerns.

• Next Generation Sequencing In Viral Safety Testing

  Next Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.

• Why Sherbrooke, Quebec Chose Pinnacle Zenith Ozone Generators To Boost Water Treatment Efficiency

  Sherbrooke, Quebec upgraded its water treatment plant with Pinnacle’s Zenith ozone system, improving disinfection, reliability, energy efficiency, and operational savings while ensuring future scalability.

• Scaling With The Client In Mind: A Customer-Centric Approach To Project Scale-Up

  In today’s fast-moving biopharma landscape, scaling from clinic to commercial takes more than expertise. See how collaboration can transform scale-up and drive confident progress

• Using Plant Peptones To Boost Plasmid Yield And Induction

  Uncover how Nu‑Tek’s plant-based peptones support E. coli growth, plasmid yield, and controlled induction, offering a sustainable, animal-free alternative for biopharmaceutical cell culture.

• Bispecific Antibodies Unleashed

  Explore how leveraging expert CDMO partnerships can streamline the development process and enhance the efficacy of your bispecific antibody therapies.

• AAV-Based Gene Editing For Huntington's Disease

  LETI-101 uses AAV5 to deliver a compact CRISPR system for allele-selective editing of mutant HTT, showing promise as a one-time treatment for Huntington’s disease with strong preclinical safety and efficacy.

• How To Unlock The Secret To Repeatable, Scalable Low Turnover

  Here, we explore the evolution of a 10-year partnership and extrapolate the principles that create cohesive teams and minimize turnover.

• 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.

• Biotech Delivers A Superior Patient And Site Experience

  To become the sponsor of choice for sites and patients in congenital hyperinsulinism clinical trials, a small biotech company prioritized delivering a superior experience while streamlining operations.

• Random And Semi-Targeted Integration In Cell Line Development

  While semi-targeted approaches may offer precision, uncover how they may fall short in overall efficiency and productivity, especially in late-stage manufacturing.

• 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.