• Vigene’s mission is to make gene therapy affordable

    We strive to achieve the vision by combining new manufacturing technologies and high yield production cell lines with rigorous quality system for cGMP.

    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 basic research side, Vigene is developing, manufacturing, and distributing state-of-the-art AAV, lentivirus and adenovirus based reagents including HHMI/Janelia Research Campus AAV Biosensors.

    On the cGMP clinical production side, Vigene is combining the proven production technologies with rigorous regulatory compliant cGMP production to meet the needs and expectations of clinical material clients Vigene o ers FDA and EMA compliant cGMP production for lentivirus, adenovirus and AAV.

    Headquartered in Rockville, MD, Vigene is a leader of both research grade and cGMP grade AAV, lentivirus and adenovirus, serving over 1000 academic, biotech and pharmaceutical labs.

    To learn more please download our updated cGMP Cell and Gene Therapy handbook.

    Visit the Vigene cGMP website

    Read editorial on growing pains for gene therapy manufacturing

    Read editorial on tripling down on efficient gene therapy production

    Updated handbook on cGMP cell and gene therapy

    Growing pains for gene therapy manufacturing

    In December 2017, the US Food & Drug Administration (FDA) approved Luxturna from Spark Therapeutics — the rst gene therapy to win market approval in the US. Several other gene therapy programs are following close behind, an indicator of a eld 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.

    The linchpin of every gene therapy is the vector, and many of today’s therapies, including Luxturna, are based around recombinant adeno- associated viruses (rAAVs), which have generally proven safe in humans and capable of e ciently delivering DNA to a variety of tissues. At least 17 di erent companies are conducting clinical trials for rAAV-based gene therapies, with three programs now in phase-3 trials. Read more

    Tripling down on efficient gene therapy production

    Three is the magic number when it comes to manufacturing vectors for NOVEL THERAPIES

    Given the considerable time and e ort 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.

    One of the central challenges of rAAV production is the need for a ‘helper virus’ to facilitate replication within a host mammalian cell. In the early days of rAAV, cultured cells would rst be infected with adenovirus, after which they would be transfected with two DNA plasmids: one containing a pair of essential rAAV genes, and the other a sequence to be employed for the gene therapy in question. This approach yields a reasonable output of fully-assembled, gene therapy-ready rAAV particles. However, these must then be separated from the also- abundant adenovirus particles that contaminate the resulting virus preparation, and can put patients at risk. Read more

    Updated handbook on cGMP cell and gene therapy

    Our facilities meet all US and EU requirements for phase I&II The new facilities and system will meet Phase III and commercial stage clinical material manufacturing requirement We have been successfully audited by multiple biotech and pharma clients All products are segregated and produced on a campaign basis and validated change-over and cleaning procedures are deployed between each project Currently, more than 20 batches of clinical materials have been successfully produced and released.

    Vigene features a strong Process Development and GMP team with accomplished virologists and technologists In addition we have an experienced team of Quality Assurance (QA) and Quality Control (QC) professionals who work alongside with the facility team, material team, PD and GMP team to ensure the end-to-end quality compliance. Download handbook to read more or visit vigenegmp.com