• Water-free vs Water Bath Cell Thawing

    Alternative to water baths for thawing frozen cells

  • R-Loops And Their Key Role In Cancer Research

    Understanding the conflicting nature of R loops and the challenges of balancing them to result in a positive effect.

  • 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.

  • Accelerating The Time To Market Of Gene Therapies Through Use Of A Platform Approach To Characterization And Safety Testing

    As gene therapies and gene-modified cell therapies show increasing promise, the need for innovative and proficient viral vector manufacturing continues to grow. Using adeno-associated virus (AAV) as one example, this white paper will describe how the implementation of platform characterization and safety assays for gene therapy vectors can increase the likelihood of success in process validation and accelerate the timeline to commercialization for gene therapy products and delivery to patients in need.

  • Industrializing Cell Therapy

    As cell therapies continue to transition from the discovery stage to therapeutic reality, with further approvals sure to come, new challenges are emerging.

  • Direct-To-Representative Sample Distribution Services

    One particularly effective approach to promote prescription drug products is to have pharma sales reps ‘hand carry’ samples to the health care practitioners within their territories.

  • Early Licensure Of A Breakthrough Cancer Drug Gives Hope To Patients

    No clinical supply request could be a higher priority than that of a physician urgently seeking an investigational cancer drug for a patient who has exhausted all treatment options. Read how named patient and expanded access programs helped speed the licensure of a breakthrough cancer drug.

  • 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.

  • The Economics Of Biomanufacturing Strategies: Can You Afford Failure?

    Prior to making critical strategy decisions, a small biotech company completed an economic evaluation of manufacturing options to ensure it was selecting the best fit for its drug development needs. Discover the critical elements of this analysis that may help to balance your expansion outlook.

  • Automated High Throughput mAb Purification Using Fibro Technology

    Biomanufacturing is trending towards higher numbers of monoclonal antibody (mAb) projects and smaller batch sizes, with production of most mAbs below 100 kg/yr. These trends are fueling demands to screen more clones faster and improve the efficiency of process development (PD). Read how the Fibro PrismA unit provides a time advantage with comparable recovery and product quality attributes to resin-based column.





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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