CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Viral Clearance: The Basics On How To Conduct Effective Studies

  Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.

• Subvisible Particulate Matter Testing

  This application note demonstrates the capabilty of advanced, automated systems for subvisible particle testing in injections, ophthalmic solutions, and lipid emulsions. 

• Comparator Local Sourcing For Clinical Trials

  This growing demand for comparators is causing many supply chain managers to explore available sourcing options. This paper examines the fundamentals of local sourcing, including the benefits and challenges of sourcing locally, and the circumstances under which local sourcing can be a sound decision. Recommendations are provided for avoiding common pitfalls in implementing a local sourcing strategy.

• Gene Selection Using PrimePCR Plates And CFX Maestro Software

  Reference gene selection and validation are very important for gene expression studies that involve different samples or experimental conditions and therefore are absolutely necessary before any further exploration. Read how PrimePCR Reference Gene Selection Panels provide an easy-to-use system with which to select appropriate reference genes.

• A Model To Increase Yield In mAb Cell Culture Perfusion At Large Scale

  As process intensification is adopted into large scale manufacturing, the responsibility of scale-down models to accurately represent the expanded operating space quickly follows. 

• Getting Your Investigational Drug Regulatory Ready

  Here, we map out basic information to help you approach regulatory policies and offer helpful strategies to facilitate efficient regulatory review and drug approval.

• Osmolality As A Concentration Measurement Method For Key Buffers In Bioprocessing

  The manufacturing of biologics is a complex and costly process by which a protein is recovered and purified of contaminants to ultimately generate a drug product. This is accomplished through a chain of filtration and chromatography processes. This study was conducted to understand how osmolality can serve as a concentration measurement and how it compares to pH and conductivity measurements.

• Single-Use Systems For Shipping Frozen Drug Materials – Every Component Counts

  Integrated single-use freeze-thaw assemblies with reliable component parts, such as the connectors supplied by CPC, have become the primary implementation choice for achieving successful drug substance transfers between manufacturing facilities.

• 8 Ways Osmolality Tests Improve Cell & Gene Process Dev, Manufacturing

  Cell and gene therapies have the potential to revolutionize incurable, debilitating, and often fatal diseases. This paper outlines eight emerging and novel uses for osmolality testing in advanced therapy production.

• Multiplexing: Managing Risk With Proven, Single-Use Solutions

  Instead of trying to make better predictions or erring on the side of overcapacity, developers and CDMOs should seek manufacturing flexibility.