Gamida eyes cell therapy regulatory nod with Lonza partnership
Gamida Cell’s product is not yet approved by any national authority but currently has an ongoing Phase III trial examining its potential as a treatment for hematological malignancies.
Omidubicel is produced through umbilical cord blood, which is then expanded through Gamida’s proprietary technology to grow cells while maintaining stem-like functionality.
The treatment has been given breakthrough therapy designation from the US Food and Drug Administration and orphan drug designation in the US and the European Union.
Gamida has chosen to remain with its existing partner, Lonza, for future commercial manufacture, continuing a five-year clinical manufacturing partnership.
Regarding the advantage of moving through clinical to commercial manufacturing with the same partner, Alberto Santagostino, head of cell and gene technology at Lonza Pharma & Biotech explained, told us, “The manufacturing process has to be well defined as we move through the clinical phases as once BLA is granted, it can be extremely difficult to make any changes. It’s crucial to get this right from the get go.”
The deal will see Lonza construct dedicated production suites at its Geleen, the Netherlands, site ahead of the commercial launch of the product. Santagostino explained that both partners will share the cost of creating the suites.
Gamida required ‘flexible and ‘scalable manufacturing’ capabilities, which is why it opted for a ‘dedicated suite model’, he told us.
The biopharma company has the option to expand the number of production suites over time to meet the potential demand for omidubicel.
Gamida, an Israel-based company, can also expand further into Lonza’s global manufacturing network, which Santagostino suggested could be desirable, as “proximity to manufacturing is a critical factor” for some cell and gene therapy companies.
CEO of Gamida, Julian Adams, noted that working with Lonza will allow the company to ensure a ‘reliable’ supply of commercial of the product, as it plans to build-out its own commercial-scale manufacturing facility.
