Lonza to make commercial gene therapies for Bluebird bio at new Texas site
The Swiss contract development and manufacturing organisation (CDMO) has provided Bluebird with clinical manufacturing services for its autologous gene therapy candidates Lenti-D and LentiGlobin, and will now provide commercial manufacturing capabilities from its site in Houston, Texas which is currently under construction.
Lenti-D is a therapy intended to prevent progression of cerebral adrenoleukodystrophy (CALD). Production involves inserting a functional copy of the ABCD1 gene in the patient’s hematopoietic stem cells outside the body, then re-introducing the genetically modified cells into the patient.
Lentiglobin, meanwhile is focused on severe sickle cell disease (SCD) and involves inserting functional human beta-globin gene into the stem cells ex vivo, which are then infused back in the patient.
Lonza told Biopharma-Reporter that while it is completing the suite design, construction and validation prior to the anticipated commercial for Bluebird’s products at the site, the facility had been commissioned to service a growing demand in this field.
“There is a solid and increasing market demand for gene therapy services,” spokesperson Dirk Oehlers said.
“Lonza has been highly active in this field for many years and we have the capabilities to serve our customers, like Bluebird and others.” Since the CDMO announced the new facility last year, it has announced a number of customer deals including manufacturing a heart failure therapy for Renova.
Oehlers added further construction on its way is “designed for serving this market demand and increasing needs.”
Large-scale transfection tech
In related news, Lonza has launched this week the 4D-Nucleofector LV Unit to its transfection platforms, used to study and control gene expression by delivering DNA or RNA and proteins into cells.
The tech allows smoother scale-up in transfection protocols, including within translational research – such as genome editing or the generation of CAR-T cells for ex vivo cell therapies which require the generation of large numbers of transiently modified cell lines or primary cells.
“The new addition of a larger-scale transfection format allows us to accompany scientists as they translate the results of their research applications into potential therapeutic applications,” said Herbert Mueller-Hartmann, head of research and technology at Lonza.
“What is really unique to our technology is the fact that the same transfection conditions can be used throughout our various conductive polymer-based platforms, which allows for real scalability.”
