Vigene maintains state-of-the-art facilities for CGMP manufacturing that fully comply with FDA and EMA guidelines. Our total available cleanroom space is 15 CGMP suites with dedicated space for viral vector production, plasmid production, and cell banking, respectively.
Our facilities meet all US and EU requirements for Phase I, II, III, and commercial stage clinical material manufacturing. 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 has highly experienced Process Development and CGMP teams with accomplished virologists and technologists. In addition, we have an experienced team of Quality Assurance and Quality Control professionals who work alongside our facility, material, and CGMP teams to ensure end-to-end regulatory and quality compliance.