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WHITE PAPERS AND CASE STUDIES

• 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.

• Bispecific Antibodies Unleashed

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

• Disinfection And Dechlorination At Alabama Power Plant

  Atlantium Technologies' HOD UV systems were installed in an Alabama electric generation plant to treat and disinfect raw water, replacing the use of chemicals and improving water quality.

• 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.

• 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.

• Simplify CAPA In 7 Steps

  Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

• Clear MRSA Infections At Single Low Doses

  Multidrug-resistant bacteria are rendering antibiotics ineffective. Review preclinical results of a potent macrocycle derivative and why collaboration is crucial to transition discoveries into treatments.

• 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.

• RO Membranes' Protection At Pinghu Power Plant, China

  A power plant in Pinghu, Zhejiang Province in China needed to replace the use of chemical biocides and protect boiler feed make-up water from anaerobic and aerobic bacterial growth and associated biofouling.

• Revolutionizing Pharmaceutical Quality Control

  Learn about a South Korean pharmaceutical company's QC laboratory and how the operation of its chromatography systems has been transformed by implementing a real-time monitoring system.

• AI Predictive Maintenance Prevents Batch Loss And Production Shutdown

  AI-powered predictive maintenance with wireless vibration sensors prevented costly batch loss and production shutdowns in pharma manufacturing by detecting and fixing equipment issues before failures occurred.

• 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.