• Downstream Process Development For Efficient Purification Of Adenovirus

    Here, we describe the development of two effective downstream processes for purification of adenovirus from cell culture harvest.

  • Trends In Protein Separation And Analysis — The Advance Of Stain-Free Technology

    Stain-free technology, a technology that existed in principle since early 2000 but was only commercialized in 2010 has changed the protein separation and analysis landscape in the past few years. This article focuses on how protein visualization is accomplished using stain-free technology, its advantages and concerns as well as how stain-free technology can change the way we carry out protein separation and analysis.

  • Integrated Pluripotent Aggregate Processing With The ekko™ System

    Pluripotent stem cells (PSCs) and induced pluripotent stem cells (iPSCs) are promising sources for the next wave of cell therapies and regenerative medicine. As with many cell therapies, one major technical hurdle is the scalable production of PSCs for commercial applications, specifically when processing these cell types in aggregate form. Read how the ekko™ system enables automation of the media exchange and subsequent harvest steps. The system is a functionally closed, integrated manufacturing platform which gently processes cell aggregates and provides the option to remove any free single cells.

  • Controlled Endpoint In Cryopreservation

    Successful cryopreservation of cells requires a controlled cooling rate. Cooling too rapidly or too slowly could lead to a poorer outcome. This application note demonstrates how controlled-rate cooling is achieved using equipment such as VIA Freeze controlled-rate freezers.

  • Complete Response: Lymphoma Trial A Success For Five Patients

    A trans-Atlantic study to evaluate an antibody for treatment of B-cell non-Hodgkins lymphoma overcame patient recruiting challenges and has already succeeded beyond expectations in the form of five patients declared disease-free a year and counting while still three years from completing patient follow-up.

  • Registry And Natural History Studies: Vital, Contrasting Roles In Rare Disease Clinical Research

    Both registry studies and natural history studies play important roles in rare disease research. Understanding the differences between the two types of studies and how they can be used to inform clinical development can help sponsors plan for success.

  • Cell Therapy Manufacturing Under GMP - How And When To Get Started

    Emerging cellular therapies aim to manufacture cell populations for clinical indications, such as cancer, autoimmune, and cardiovascular diseases. As hospitals and translational facilities explore implementation of this technology they concurrently evaluate whether or not to manufacture the therapies onsite. Here is a guideline of how and when to get started.

  • Strategies To Address The Viral Vector Manufacturing Shortage

    Accelerating the production of your viral-vector based therapy requires understanding the strategies and cost-efficiencies available to address the viral vector manufacturing shortage.

  • 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.

  • Sorting Bone Marrow Mesenchymal Stem Cells With The S3 ™ Cell Sorter

    In this study, a S3 Cell Sorter was used to analyze and purify prospective MSCs from passage 1 (P1) and passage 3 (P3) bone marrow cultures. The data presented here shows the capability of the S3 Cell Sorter to isolate rare MSCs from a mixed bone marrow culture with satisfying sort efficiency and postsort purity.





Research and development of cell therapies and gene therapies continue to grow quickly, and regulatory oversight of these therapies is paramount to continued sector success. For your reference, we’ve compiled this one-stop, data-rich repository of regulatory information — from challenges and the short-term outlook facing the cell and gene sector’s regulatory landscape to analyses of FDA’s recently issued guidances.


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