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WHITE PAPERS AND CASE STUDIES

• Organizational Assessment For A Large MedTech Company

  Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.

• 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.

• MBR Solutions For Modern Industries

  This white paper will explore advanced, sustainable wastewater management systems that align with your business's growth trajectories and emergent needs. 

• 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.

• Optimizing Upstream Process Development To Increase mAb Titers

  Uncover how we were able to help a client develop an efficient upstream process for a novel monoclonal antibody (mAb), resulting in a more than 100% increase in titers.

• 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.

• 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.

• Achieving Faster Timelines And Cost Savings Through Digital Validation

  Examine how the Project Ready program was leveraged to streamline validation processes for a CDMO, resulting in a 25% reduction in budget and faster project completion.

• 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 ABB Is Helping Optimize Combustion At Twence's Waste-To-Energy Plant

  Maintaining the right level of oxygen is crucial for combustion optimization. Too much excess oxygen equals decreased efficiency. Read more about how ABB is helping Twence optimize combustion in their waste-to-energy plant in the Netherlands.

• Membrane Adsorber Chromatography In Oligo-mAb Conjugation

  Discover how the team was able to expedite the conjugation of an oligonucleotide-monoclonal antibody (oligo-mAb) program leveraging experience in chromatography.

• Modifying The Micro-Environment To Improve Dissolution Rate

  Discover how modifying the micro-environment with targeted excipients can significantly enhance the dissolution rate of poorly soluble drugs using conventional manufacturing methods.