Operations Commence At Genezen's Lenti- And Retroviral Vector Process Development Lab
Genezen, Inc., a cell and gene therapy Contract Development and Manufacturing Organization (CDMO) focused on early-phase process development, vector production and analytical testing services, has officially opened its new process development and analytical lab.
The lab will deliver a full suite of process development capabilities to support cGMP and commercial readiness, upstream and downstream process improvements, research grade and preclinical vector production, and analytical assay development and validation from the site.
The lab is the first phase of a multiphase master plan for a 75,000+ square foot cGMP-compliant lentiviral and retroviral vector production facility. The next phase, with cGMP production suites, is currently underway and due to complete in early 2022.
“The opening of our dedicated viral vector process and analytical development lab is a key milestone for us in launching our additional early-stage capabilities needed to drive the cell and gene therapy industry forward,” said Ray Kaczmarek, Chief Executive Officer at Genezen.
“Our deep expertise in development and manufacture of viral vectors coupled with this new facility and equipment will accelerate our partners’ abilities to advance life-saving therapies into the clinic.”
Once finished, the state-of-the-art facility will deliver aseptic manufacturing of lentiviral and retroviral vectors from multiple cGMP production suites and will offer capabilities for host cell expansion, host cell banking, and viral vector production via transient transfection and producer cell lines.
Analytical testing services, including Recombinant Competent Lentivirus (RCL) testing, vector stability testing, and safety and sterility testing, will also be available from the site.
The end-to-end capabilities will facilitate Genezen’s delivery of optimized closed and semi-automated processes for viral vector production.
Genezen will continue to provide cell manufacturing and patient sample testing through its existing academic partnerships.
Construction of the new facility has been funded by a majority investment from Ampersand Capital Partners, a private equity firm specializing in growth equity investments in the healthcare sector.
About Genezen, Inc.
Founded in Indianapolis in 2014, Genezen is focused on supporting the demands of the current and future gene and cell therapy manufacturing market worldwide— making viral vector production accessible to both early-stage, growth-oriented companies and established industry leaders. Genezen offers early-phase process development, GMP lentiviral vector production, retroviral vector production, and analytical testing services, building on the company's expansive knowledge and experience in the industry and working with the nation's leading institutions. For more information, visit www.genezen.com.
About Ampersand Capital Partners
Founded in 1988, Ampersand is a middle market private equity firm with more than $2B of assets under management dedicated to growth-oriented investments in the healthcare sector. With offices in Boston, MA and Amsterdam, Netherlands, Ampersand leverages a unique blend of private equity and operating experience to build value and drive superior long-term performance alongside its portfolio company management teams. Ampersand has helped build numerous market-leading companies across each of the firm's core healthcare sectors. For more information, visit www.ampersandcapital.com.
Source: Genezen, Inc.