Johnson & Johnson and Bristol Myers Squibb Race to Expand CAR-T Manufacturing Capacity Amid Growing Demand

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Johnson & Johnson and Bristol Myers Squibb have recently received expanded approval for the indication of multiple myeloma, accelerating lentivirus production and CAR-T product capacity respectively.

Johnson & Johnson's Vice President of Advanced Therapies Supply Chain, Kimberly Lounds Foster, stated in an interview that Johnson & Johnson, in collaboration with its partner Legend Biotech, plans to double the production capacity of Carvykti by the end of 2024. She added that, to date, Carvykti has been administered to more than 2,700 patients.

Bristol Myers is also increasing its Abecma manufacturing with partner 2seventy bio to "meet unrestricted demand."

Carvykti's sales have stabilized over the past three quarters. However, the company emphasized on Tuesday's earnings call that the slight decline in sales in recent months was not related to manufacturing, but rather due to the timing of orders and product deliveries. In the second half of 2023, Abecma's revenue was impacted by a planned maintenance-related shutdown.

According to Foster, one of Johnson & Johnson's competitive advantages is its internal lentivirus production. "Traditionally, Lenti manufacturing has been a significant bottleneck for many CAR-T players post-approval," she said.

Foster said that Johnson & Johnson has expanded its lentivirus production volume from 20 liters to 50 liters in the United States and Switzerland. She mentioned that the company plans to further increase lentivirus production capacity in the United States later this year and will launch a new commercial-scale lentivirus production facility in the Netherlands in 2025. However, she added that, for now, it already has an "unrestricted" supply of lentivirus.

A spokesperson for BMS stated that BMS is also increasing its production yield by incorporating suspension lentiviral vectors into its manufacturing process through collaboration with CDMO partner Resilience.

Johnson & Johnson is seeking to increase the production capacity of its Carvykti product. Foster said that the company’s plant in Belgium produced the first clinical dose of CAR-T therapy earlier this year and is scheduled to begin commercial production in the second half of 2024, with plans to scale up in 2025. Johnson & Johnson is already producing Carvykti for commercial use at a plant in Raritan, New Jersey.

Johnson & Johnson has room to increase more capacity by cooperating with Novartis' CDMO department, but Foster refused to disclose details. Johnson & Johnson cooperated with Novartis in April 2023 to produce clinical and commercial Carvykti.

A spokesperson for BMS stated that it is also increasing its production capacity, including the completion of a new facility in the Netherlands, which is set to begin operations later this year. BMS has battery production bases in Bothell, Washington; Warren and Summit, New Jersey; and Devens, Massachusetts.

On Tuesday, Johnson & Johnson reported $157 million in sales of Carvykti in the first quarter of 2024. Sales have been relatively stagnant, with $159 million in the fourth quarter and $152 million in the third quarter, up from $117 million in the prior three months. Foster said the slight decline in the first three months of 2024 was due to "the timing phase of actual product delivery."

Source of the article: https://endpts.com/