The cGMP facility in Houston, Texas, has been validated and technology has been transferred allowing the manufacture of autologous virus-induced immunotherapy products. The announcement comes seven months after Lonza announced expansion plans and less than three years since it entered the viral business.
Lonza’s Head of Viral-Based Therapeutics, David Enloe, said: “We are pleased to have been selected by our existing viral vector client to additionally perform the development and manufacture of virally-modified cellular products to support its clinical studies.”
He added: “As the field of regenerative medicine expands to include combination products, we are pleased to grow with the field and offer seamless contract manufacturing services for the development and manufacture of these unique products.”
Lonza has been in collaboration with Avalanche Biotechnologies since last year, developing and producing adeno-associated vectors (AAV) based on a baculovirus technology licensed from Californian based developer Virovek.
AAV is a virus which due to its limited capacity in inducing immune response from humans can be used efficiently in vector transduction without risking disease in humans. According to San-Francisco-based Avalanche, AAV based vectors can deliver genes or RNAi at up to 100 percent efficiency to numerous cell types.
Lonza’s drive to expand facilities was driven by the triumvirate with Avalanche and Virovek but the Swiss company is now ready to offer new clients its services.
The cell-processing suites and a completed tech transfer process for a new virally-transfected T-cell product will allow Lonza to offer autologous cellular immunotherapy development to its customers.