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

• Purification Of Antibodies With Hydrophobic Anion Exchange Resin

  A hydrophobic anion exchange mixed-mode resin has been developed to overcome challenges in antibody purification. This application note describes the purification of acidic and basic antibodies using this resin.

• Single-Use Fluoropolymer Bags For Efficient High-Density Cell Banking

  This paper explains how single-use bags perform during freezing, storage, and thawing steps and why they present an efficient alternative to vials in a variety of upstream cell banking applications.

• How COVID-19 Is Making Operationalizing Gene Therapy Trials Even Tougher – And How We Handled It

  The global pandemic has exacerbated the operational challenges intrinsic to gene therapy at the site level, the project team level, and the sponsor level. To ensure that studies continue to move forward, strategies need to be considered not only for operational efficiency and patient centricity but also as contingency planning in the case of a subsequent wave or quarantine. Here we continue our case study of a rescue Phase 1/2 gene therapy trial involving localized administration of gene therapy using specialized equipment with a look at the operational challenges of these trials during COVID-19.

• Downstream Process Intensification Of Virus Purification Using Single-Use Membrane Chromatography

  The production of viruses, whether for use as viral vaccines, viral vectors for gene therapy, or oncolytic applications, requires complex processes that can translate into high costs, as well as slow development timelines and time to market. This article presents several case studies highlighting the advantages of process intensification using Natrix^® single-use membrane chromatography to increase your productivity and reduce your capital and operational manufacturing costs.

• Validating The Stability And Durability Of Labels After Thawing From Cryogenic Temperatures

  One important element of working in cryogenic temperatures involves ensuring labels remain intact and securely adhered to packaging after application as product moves from ambient temperatures to cryogenic temperatures to thawing at the point of use. The following study serves as a model for the need to validate label stability and adherence and is an example of the many different types of validation studies we regularly conduct to mitigate risk for customers during all phases of an advanced therapy clinical trial.

• EDGE Confocal Imaging Technology

  Increasingly, scientists are being challenged to study more biologically-relevant model systems, and this often means imaging thick, demanding 3D samples that may also be alive. Read how IRIS and EDGE confocal imaging can offer high contrast imaging of thicker samples.

• 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.

• A New International Standard To Measure DNA?

  The breadth of digital PCR (dPCR) applications continues to grow and fulfill critical scientific needs. One of the major advantages the technology confers is the ability to count nucleic acid molecules directly, rather than extrapolating quantity based on standard curves as with many other methods. By harmonizing diagnostic procedures on dPCR platforms, the scientific and medical communities can become more coordinated and efficient than ever before.

• Process Development For Scaled-up hESC/hiPSC Manufacturing

  A manufacturer faced a challenge to scale up, close and optimize a suspension-based manufacturing workflow for pluripotent stem cells (PSCs). In response, CCRM developed an optimized 14-day manufacturing workflow, which produces >10¹⁰, cells, in < 12 months.

• 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.