Vigene Biosciences

Rockville,  MD 
United States
http://www.vigenebio.com


Vigene Biosciences welcomes you and your team!

Vigene features integrated plasmid and viral vector production and analytical service offerings from its 110,000 sq ft of state-of-the-art facility with over 15 GMP cleanroom suites. On basic research side, Vigene is developing, manufacturing, and distributing state-of-the-art AAV, lentivirus, retrovirus, adenovirus, and plasmid-based reagents. On the cGMP clinical production side, Vigene combines the proven production technologies with rigorous regulatory compliant cGMP production. Vigene’s mission is to make gene therapy affordable.

Brands: Vigene Biosciences offers research-grade and cGMP production of AAV, lentivirus, retrovirus, adenovirus, and plasmid that complies with FDA and EMA guidelines.


 Products

  • AAV Reference Materials
    Vigene is now offering AAV reference materials of full capsids and empty capsids of 6 different serotypes. These well-characterized reference standards are extensively analyzed with molecular based assays and transmission electron microscope....

  • Reference standards or materials are controls or standards for quality control assays and methods. In the field of gene & cell therapy, reference materials are critical for comparability between studies and clinical trials. Previously, the only available AAV reference standards or materials are provided by ATCC over a decade ago. As a leader in AAV production and analytical assays, Vigene is now offering AAV reference materials of full capsids and empty capsids of 6 different serotypes. These well-characterized reference standards are extensively analyzed with molecular based assays and transmission electron microscope.

    Commercially supplied reference standards obtained from a reputable commercial source can be used in addition to certified reference standards, according to FDA gene therapy CMC guidance, released in January, 2020, “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)”.