Vigene maintains state-of-the-art facilities for GMP manufacturing that fully comply with FDA and EMA guidelines. We currently have 4,000 sq. ft. of classified cleanroom space available for sterile manufacturing, containing a total of 5 GMP suites. In mid-2019, we will open a new facility with 5 additional GMP suites, bringing our total available cleanroom space to ten GMP suites amounting to >10,000 sq. ft. With the addition of the 5 GMP suites, we will have dedicated space for viral vector production, plasmid production, and cell banking, respectively.
Our facilities currently meet all US and EU requirements for Phase I & II. Beginning in mid-2019, our operations will meet Phase III and commercial stage clinical material manufacturing requirements. 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 GMP 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 GMP teams to ensure end-to-end regulatory and quality compliance.