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

  • What Cleanroom Build Method Is Best For You?

    Your future cleanroom is a critical asset, it is not just another construction project. The investment you make in the cleanroom facility is significant and it should perform for years to come. Learn the relative strengths and weaknesses of various cleanroom construction methodologies that are being implemented within the marketplace.

  • Is A Rapid Cooling Step Needed When Freezing Cells For Cryopreservation?

    Successful cell cryopreservation requires a controlled cooling rate. Cooling too rapidly or too slowly will lead to a poorer outcome. This study shows comparable results when freezing cells with or without a rapid-cooling nucleation step.

  • 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.

  • De-Mystifying And De-Risking Process Development Through Early Engagement With A CDMO

    An overview of how CDMOs can help companies get started in the world of CGT manufacturing, with considerations around timing of engagement to maximize commercial and clinical success.

  • Improved Process Economics Of Humira Biosimilar Purification

    This application note proposes an alternate but equally effective approach to biosimilar purification, by substituting a less expensive ion exchange resin for the affinity capture step.

  • Commercial Scale Manufacturing of Allogeneic Cell Therapy

    Allogeneic cell therapy products are generating encouraging clinical and pre-clinical results. Many of these therapies are also expected to have large market sizes and require cell doses of ≥109 cells. As therapeutic technologies mature, it is essential for the cell manufacturing industry to correspondingly develop to adequately support commercial scale production. To that end, there is much that can be learned and adapted from traditional manufacturing fields. In this review, we highlight key areas of allogeneic cell therapy manufacturing, identify current gaps, and discuss strategies for integrating new solutions.

  • Freezing Cellular Raw Materials For Cell Therapy Production

    Key Biologics is harnessing new freezing technology to help deliver the future of medicine. Digitally enabled cryogenic cold chain technology can now deliver the raw materials needed to manufacture cellular therapies.

  • What Is The Cost Of Not Doing MES?

    In this age of digitization, many pharma and biotech companies still struggle to gain senior level buy-in for investments in manufacturing IT. This whitepaper covers major saving areas with MES as well as typical steps to evaluate ROI.

  • Chill Out: Harnessing New Freezing Technology To Help Deliver The Future Of Medicine

    Digitally enabled cryogenic cold chain technology can now deliver the raw materials needed to manufacture cellular therapies

  • Alternative To Cryobags For Large Volume Cryopreservation

    This study demonstrates an optimized cooling protocol for cryopreserving large-volume cryovials in a controlled-rate freezer, avoiding the need for liquid nitrogen.

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Download this free collection of articles and learn how to let go of legacy aseptic filling line equipment, seven common filling blunders and how to avoid them, nontraditional design concepts for CAR T processing, what to do when your isolator is taking too long to de-gas. Herman and Erich Bozenhardt bring a collective 54 years of bioprocess facility design and production experience to the pages of this comprehensive ebook.

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