INSIGHTS ON CELL & GENE MANUFACTURING

  • Lentiviral Vector Scale-Up Workflow In Single-Use Bioreactors Enables GMP Compliance
    Lentiviral Vector Scale-Up Workflow In Single-Use Bioreactors Enables GMP Compliance

    As gene transfer vehicles, lentiviruses exhibit many desirable properties, such as high transduction efficiencies, ability to infect both dividing and nondividing cells, and stable integration into the host cell genome. These properties make them well-suited for in vivo and ex vivo gene and cell therapies. However, cost-effective manufacturing of lentiviral vectors (LV) at commercial scales has proven difficult and remains a pressing issue for the marketing of therapies that depend on their application.

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

  • How To Scale-Up Lentiviral Vector Production Part 2: Considerations For Downstream Processing
    How To Scale-Up Lentiviral Vector Production Part 2: Considerations For Downstream Processing

    Lentiviral vectors (LVV) are a key component in the production of cell and gene therapies. Today, even with the proliferation of cell and gene therapies in development, LVV is still produced using legacy methods employed in basic research. Overcoming technical challenges in the scale-up of LVV production is a major focus for the industry. Here we break down DSP into unit operations and understand how process innovations are contributing to scalability at each step.

  • How To Scale-Up Lentiviral Vector Production Part 1: Considerations For Upstream Processing
    How To Scale-Up Lentiviral Vector Production Part 1: Considerations For Upstream Processing

    Lentiviral vectors (LVV) are a key component in the production of cell and gene therapies. Today, even with the proliferation of cell and gene therapies in development, LVV is still produced using legacy methods employed in basic research. Overcoming technical challenges in the scale-up of LVV production is a major focus for the industry. This blog explores the principles that govern the scaling of upstream processing (USP).

  • 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.

  • Concentration And Reformulation Of Cellular Immunotherapies – A Major Downstream Processing Step
    Concentration And Reformulation Of Cellular Immunotherapies – A Major Downstream Processing Step

    Cellular immunotherapies (e.g. CAR-T cells) are primarily used as an autologous therapy to treat cancer. As such, these therapies are currently generated in small batches for each patient. To generate enough modified cells for a single treatment, cells are expanded in volumes from 1-10 L. In the final step of downstream processing (DSP) for immunotherapies, cells cultured in large volumes must be concentrated and reformulated into smaller volumes (e.g. 20-100 mL) suitable for delivery to patients. In this post, we will outline the key steps for concentration and reformulation and highlight specialized equipment needed for this critical unit operation.

  • 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.

  • Automating Cell Therapy Manufacturing For Increased GMP Compliance And Consistency
    Automating Cell Therapy Manufacturing For Increased GMP Compliance And Consistency

    Exploring the use of automation in cell therapy and advanced therapeutic medicinal product manufacturing to improve safety, quality, and compliance is a key factor in advancing patient care.

  • 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.

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