Johnson & Johnson and Bristol Myers Squibb are individually gearing up their lentiviral production and CAR-T product capacities following their recent label expansions in multiple myeloma.
J&J, alongside partner Legend Biotech, has its eyes on doubling its Carvykti capacity by the end of 2024, said Kimberly Lounds Foster, J&J vice president for advanced therapies supply chain, in an interview with Endpoints News. Carvykti has been administered in over 2,700 patients so far, she added.
Bristol Myers is also increasing its Abecma manufacturing with partner 2seventy bio to “meet unconstrained demand,” a spokesperson told Endpoints in an email.
Carvykti sales have plateaued in the past three quarters. But the company emphasized during its earnings call on Tuesday that the slight decline in sales in recent months is unrelated to manufacturing and is due to the timing of orders and when products are delivered. In the latter half of 2023, Abecma revenues were impacted by production pauses due to scheduled maintenance.
Kimberly Lounds FosterAccording to Foster, one competitive advantage for J&J is its internal lentiviral production. “Lenti manufacturing has traditionally been a high constraint for a lot of CAR-T players post approval,” she said.
J&J scaled up its lentivirus production from 20 liters to 50 liters in the US and Switzerland, said Foster. The company is planning on adding further lentivirus capacity in the US later this year, and will launch a new commercial-scale lentivirus manufacturing facility in the Netherlands in 2025, she said. But for now, it already has a “fully unconstrained” supply of lentiviruses, she added.
BMS is also ramping up production by adding suspension lentiviral vectors into its manufacturing processes with its CDMO partner Resilience, the BMS spokesperson said.
J&J is looking to lift its product capacity for Carvykti. Its facility in Belgium manufactured its first clinical dose of the CAR-T therapy earlier this year and will be ready for commercial production in the latter half of 2024, with plans to expand in 2025, Foster said. J&J already manufactures Carvykti for commercial use at a site in Raritan, NJ.
J&J has room to add more capacity through its partnership with Novartis’ CDMO arm, but Foster declined to detail specifics. J&J partnered with Novartis to manufacture clinical and commercial Carvykti in April 2023.
The BMS spokesperson said it is similarly gearing up capacity, including the completed construction of a new facility in the Netherlands, which is set to be operational later this year. BMS has cell manufacturing sites in Bothell, WA, Warren and Summit, NJ, and Devens, MA.
On Tuesday, J&J said it made $157 million in Carvykti sales in the first quarter of 2024. Sales have been fairly stagnant, with fourth-quarter sales at $159 million and $152 million in the third quarter, which is a jump from $117 million in the three months prior. The slight dip in the first three months of 2024 is due to “a time phasing of when the product is actually delivered,” Foster said.
Meanwhile, BMS made $100 million in Abecma sales in the last quarter of 2023, up from the $93 million reported for the previous quarter. BMS is due to report its first-quarter earnings next week.
J&J first won FDA approval for Carvykti in February 2022 as a fourth-line treatment or later in multiple myeloma, while BMS secured its approval for Abecma in March 2021 for the same patients. The recent label expansions for both CAR-Ts allows their use as early as second line.