Lonza: Out of spec Kymriah ‘not a Novartis issue…it’s an industry issue’
Novartis announced its chimeric antigen receptor (CAR) T-cell therapy Kymriah (tisagenlecleucel) had “some variability…in product specifications” during a Q2 investor call earlier this month.
The Swiss drugmaker manufactures Kymriah at its Morris Plains facility in New Jersey, and earlier this month signed a CAR T-cell manufacturing agreement with French contract development and manufacturing organisation (CDMO) Cell for Cure.
While the firm did not reveal specifics, CEO of Novartis Oncology, Liz Barrett, told investors “[the] commercial label [indicating the percentage of viable cells after manufacturing] is slightly more stringent than [in] our clinical study. So…some of them are out of spec because they are not at the same level.”
According to Richard Ridinger, CEO of CDMO Lonza, these commercial manufacturing concerns reflect the “extremely new” nature of the gene-edited technology field.
On account of CAR T-cell therapy’s “positive effect’ in the clinic, and its potential future demand, there is a “higher need,” Ridinger told investors during in a Q2 earnings call: “This, I see, as a challenge in the industry. It’s not a Novartis issue…it’s an industry issue.”
A Lonza solution?
According to Ridinger, the answer is increased investment in technology development: “A new technology needs literally new technology, in terms of resolving those problems. I [won’t] go into detail, but we are also working to be one of [the companies] who is going to resolve that.”
“A lot of manufacturing technologies are under development in this area. We have ourselves developed…unique manufacturing technologies for this area because we want to be an instrumental part…in making those processes stable and affordable in [the] future.
“Be reassured…Lonza wants to be part of the solution going forward,” he added.