When the facility was originally announced, in August 2018, it was projected to be completed in early 2020, but the company has managed to ready the CHF 90m (€79m) facility earlier than this timeline.
According to the company, the first clinical production of a cell and gene therapy batch was completed in September 2019, at the newly opened Stein, Switzerland facility.
After the European approval for Kymriah (tisagenlecleucel), the company has focused on building out capacity to meet demand in the region.
This includes acquiring its former manufacturing partner for Kymriah, when it purchased CellforCure. At the time of the announcement, Novartis revealed that production of Kymriah would begin by mid-2019 after the deal had been completed.
The Stein facility will also focus on the production of chimeric antigen receptor (CAR)-T therapies, with commercial production expected to be completed in the first quarter of 2020, subject to regulatory approval.
At present, the facility has created 185 positions in cell and gene therapy, with a further 265 expected to be added over the next few years.
Producing Kymriah has not been without its difficulties for the Swiss company, with it previously telling investors that it had struggled with meeting product specifications.
As a result, the company pledged to invest into its cell therapy manufacturing network and to speed up the process of digitization, whilst also moving investment away from traditional production technologies.
In third quarter financials, Kymriah was able to repay some of this investment with strong growth, after making $79m (€71m) in the third quarter – representing growth of 295% over the previous year’s results, though these were released shortly after the product gained European approval.
In addition to the investment in cell and gene manufacture and announcing that it was looking away from traditional processing, Novartis also stated that the new facility would hold capabilities to produce solid dosage forms, including tablets and capsules.
