Novartis has reported issues around the manufacture of Kymriah (tisagenlecleucel). With CAR-T being a new field, teething problems are normal, says CDMO Lonza.
In August 2017, Novartis became the first company to receive US Food and Drug Administration (FDA) approval for a chimeric antigen receptor (CAR) T-cell therapy. But during its Q2 results, the Swiss Biopharma admitted some issues in the manufacturing of the therapy for its diffuse large B-cell lymphoma (DLBCL) indication.
“We have seen some variability in our product specifications,” CEO Vasant Narasimhan told stakeholders. “This is something we’re looking at now in DLBCL to make sure that we can continue to ramp-up the demand.”
Liz Barrett, CEO of Novartis Oncology added the firm is working directly with the FDA on trying to resolve the issue “as well as looking at new ways to improve our output to meet more commercial specification on Kymriah.”
Second quarter Kymriah sales stood at US$16 million (€13.7 million).
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Barret also said variability in commercial specifications isn’t unusual with a new therapy such as CAR-T as it launches into a new target patient population, something reiterated last week by contract development and manufacturing organization Lonza.
“We all need to be aware, this is an extremely new field,” said CEO Richard Ridinger. “[The] challenge in the industry: It’s not a Novartis issue, I think, it’s an industry issue.”
He also compared teething problems in CAR-T manufacture with stability issued in the production of biologics 15 or 20 years ago, saying “it was not so much different.”
And, he continued, “Lonza wants to be a part of the solution going forward” and is developing “maybe quite unique manufacturing technologies” to make CAR-T processes stable and affordable in the future.
When contacted by BioProcess Insider, Lonza declined to add any further details at this time.
Lonza has invested heavily in cell and gene manufacturing over the past few years. In May 2017, Lonza expanded its capabilities and footprint through the acquisition of European CDMO PharmaCell. And in April this year, the firm opened a 300,000 square feet dedicated cell and gene manufacturing therapy facility in Houston, Texas.
For the first six months 2018, Lonza reported sales of 1.6 billion CHF ($1.6 billion).