• Vigene’s mission is to make gene therapy affordable

    cGMP Overview

    Vigene is a leading gene and cell therapy contract development and manufacturing organization (CDMO) that strives to deliver the highest quality processes and products to our clients.

    On the basic research side, Vigene is developing, manufacturing, and distributing state-of-the-art AAV, adenovirus, and lentivirus based reagents.

    On the cGMP clinical production side, Vigene is combining these proven production technologies with large-scale cGMP production methods to meet the needs and expectations of our clients Vigene offers FDA and EMA-compliant cGMP production for AAV, adenovirus, and lentivirus, along with a variety of other services. To date, we have offereed our services to over 1,000 academic, biotechnology, and pharmaceutical labs.

    To learn more about our cGMP biomanufacturing technologies and services, please visit the Vigene cGMP website or download our updated cGMP Cell and Gene Therapy handbook.

    Article Series from Nature on Gene Therapy

    Vigene has partnered with Nature to create a four-part series of articles highlighting new production strategies and technologies in the world of gene therapy. Please read the articles below to learn more!

    Read editorial on growing pains for gene therapy manufacturing

    Read editorial on tripling down on efficient gene therapy production

    Growing pains for gene therapy manufacturing

    In December 2017, the US Food & Drug Administration (FDA) approved Luxturna from Spark Therapeutics — the first gene therapy to win market approval in the US. Several other gene therapy programs are following close behind, an indicator of a field poised for rapid growth. Yet success brings new obstacles, and after overcoming decades of setbacks, gene therapy’s pioneers face the challenge of manufacturing cutting-edge treatments at scale.

    Tripling down on efficient gene therapy production

    Given the considerable time and effort companies have invested in gene therapy, most prefer to play it safe when it comes to manufacturing. Accordingly, the large majority of recombinant adeno- associated virus (rAAV)-based therapies—which account for most gene therapies—are still produced with a method developed more than two decades ago, known as the ‘triple transfection’ technique.