INSIGHTS ON CELL & GENE OUTSOURCING ISSUES

  • Considerations For The Use Of Stable Producer Lines In The Manufacturing Of Lentiviral Vectors
    Considerations For The Use Of Stable Producer Lines In The Manufacturing Of Lentiviral Vectors

    There are many challenges with transfection-based protocols for producing LVVs at large scale. Here we will take a closer look at the use of stable producer cell lines as an alternative to transient transfection for the manufacture of LVVs.

  • What Is The Best Way To Manufacture Lentiviral Vectors For Cell And Gene Therapies?
    What Is The Best Way To Manufacture Lentiviral Vectors For Cell And Gene Therapies?

    In the field of cell and gene therapy, there are two main types of viral vectors: adeno associated virus (AAV) and Lentivirus (LV). The manufacture of these vectors is dependent on the regulatory requirements dictated by its end use. This blog outlines the challenges for optimization of scaled-up LV manufacturing processes and new technologies being used to solve these challenges.

  • Innovative Development And Manufacturing Services For Global Cell And Gene Therapy Leaders

    CCRM is a full-service concept-to-market CDMO. We makes it easier for cell and gene therapy companies to accelerate commercialization of their emerging therapies and technologies at our full-service cGMP-compliant facility.

  • Five Steps To Ensure Your Cell And Gene Therapy Product Is GMP Compliant
    Five Steps To Ensure Your Cell And Gene Therapy Product Is GMP Compliant

    To prepare the product for in-human testing clinical protocols are developed in consultation with the regulatory authorities, a target patient population is identified, clinical investigators and an appropriate contract research organization are selected, and funds are obtained. What is sometimes overlooked, or left to the last minute, is the less-than-glamorous, but still critical, manufacturing steps that ensure a new, potentially life-saving treatment reaches patients in a safe and reliable form. In this post we will map the five critical steps that require thoughtful measured consideration for a CGT product to be produced in a good manufacturing practices (GMP) facility.

  • Best Practices For A Successful Bioprocess Technology Transfer
    Best Practices For A Successful Bioprocess Technology Transfer

    A well-executed bioprocess technology transfer (tech transfer) is critical to ensure smooth knowledge transfer and optimal process reproducibility. If not executed properly, you risk reducing the quality and efficiency of your process. Waste time trouble shooting, and you may delay your time to market. In today’s global markets effective tech transfer is critical.

  • How Important Is Geography To Today’s Outsourcing?
    How Important Is Geography To Today’s Outsourcing?

    A recent CDMO press release essentially asserted superiority via proximity: Geography as God of outsourcing. I contacted two biopharma executives familiar with the Boston/Cambridge scene for reactions: Michael Kaufman, Senior Vice President, CMC, Mersana Therapeutics, and 15-year veteran of Merck; and George Avgerinos, Senior Vice President of Biologics Operations, Fortress Biotechnologies, and 22-year veteran of BASF/Abbott/Abbvie.

  • Catalent Biologics: Delivering Therapies To Market Faster
    Catalent Biologics: Delivering Therapies To Market Faster

    Catalent Biologics is an integrated partner with expertise to get a biologic to market faster. The company has the passion to help its partners accelerate, simplify and de-risk their biologic therapies -- from development and manufacturing, to fill/finish, clinical supply and commercial launch.

  • Catalent Clinical Supply Services
    Catalent Clinical Supply Services

    Whether you have a large, complex global study or need a small, regional solution, we can reliably supply your clinical trial anywhere in the world. From Phase I to Phase III and beyond, we are the catalyst for your success.

  • A Solution To Ensure Quantity & Quality Of The Excipient Polysorbate-80 In Drug Formulations
    A Solution To Ensure Quantity & Quality Of The Excipient Polysorbate-80 In Drug Formulations

    Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors.

  • How To Address Process Characterization And Late Phase Development Of A Monoclonal Antibody
    How To Address Process Characterization And Late Phase Development Of A Monoclonal Antibody

    Process characterization is an important step in the overall journey of product development. In this poster, scientists at propose a step-wise approach for the definition and execution of process characterization for the production of a monoclonal antibody.

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