Manufacturing of cancer drug Trodelvy will be moved to Oceanside, California as part of a restructuring of Gilead Science’s New Jersey operations.
In September 2020, Gilead paid $21 billion to acquire Immunomedics. The deal added antibody-drug conjugate (ADC) Trodelvy (sacitizumab govitecan) – approved in April 2020 to treat triple negative breast cancer – to Gilead’s portfolio, along with an biomanufacturing facility in Morris Plains, New Jersey.
But plans to create a corporate hub in Northern New Jersey will result in the closure of this facility, a Gilead spokesperson confirmed.
The Morris Plains, NJ plant is set to be shuttered. Image c/o Googlemaps
“Manufacturing operations will move to Oceanside,” BioProcess Insider was told. “We will look to decommission the existing Morris Plains site only once we have a new site established.”
The Morris Plains site first received US Food and Drug Administration (FDA) approval in 1998 for Immunomedics’ antibody-based diagnostic product, CEA-Scan. In 2019 it was cited in an FDA complete response letter (CRL) to sacitizumab govitecan’s regulatory submission due to issues within the facility’s quality unit.
Oceanside, meanwhile, focuses on supporting clinical manufacturing and process development for Gilead and its cell therapy subsidiary Kite. The firm announced an expansion at the site to support viral vector production in 2019, and earlier this month acquired 27 acres of undeveloped neighboring land to support future expansion projects.
While the company did not say if any jobs will be lost, a New Jersey Worker Adjustment and Retraining Notification (WARN) states 114 Morris Plains-based employees will be let go by the end of 2022 in three batches, the first beginning in April. New Jersey Business Magazine claims these jobs will be transferred to Oceanside.
Financial details regarding the new corporate site in New Jersey – which will be able to house up to 500 employees once fully operational – have not been divulged, but “it will be one of the largest non-manufacturing investments we have made in a physical US site outside of our Foster City headquarters,” the spokesperson claimed.
“The new office space will focus on corporate functions at a variety of levels, such as medical affairs, regulatory affairs, operations, engineering, quality and supply chain. Gilead is committed to establishing our New Jersey location as a talent hub that will further solidify our East Coast presence, support future growth and attract the best candidates in the region.”