Cell Therapy Manufacturing Expansion

Johnson & Johnson and Legend Biotech are preparing for the next stage of their cell therapy manufacturing expansion, with the companies on track to reach its long-stated capacity goal for multiple myeloma therapy Carvykti in 2025.

The two businesses have authorized an additional expenditure of roughly $150 million to increase the future capacity of a new plant in Ghent, based on internal demand predictions. Legend and Johnson & Johnson made the decision to make the new investment just a few weeks before the Tech Lane facility is scheduled to start clinical manufacturing of Carvykti. By the end of 2025, it is anticipated that the site will be approved to begin commercial supply.

Over the past few years, Legend and Johnson & Johnson have been working hard to increase their ability to manufacture cell therapies. Due to supply issues, the CAR-T therapy's revenue growth has been constrained since Carvykti's initial FDA clearance in early 2022. Additionally, another FDA approval in April 2024 for second-line multiple myeloma nearly quadrupled the number of patients who might use the medication.

The FDA has approved Novartis, a contract manufacturer, to produce Carvykti commercially at its facility in Morris Plains, New Jersey, as part of the two companies' recent attempts to increase supply. In the autumn of 2022, Legend and Johnson & Johnson announced that they would increase the investment in their flagship Raritan manufacturing facility in New Jersey to a total of $500 million. Legend now anticipates receiving regulatory approval in the second part of this year for a new portion at that location.

According to Legend, the firms' other location in Ghent, known as the Obelisc factory, started commercial production in the third quarter of 2024 and is currently running at full capacity. With the aid of these recent additions, the firms will be able to meet their 2023 objective of producing 10,000 doses of Carvykti annually this year.

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