Mfg News: Gilead, Seagen, Lupin & More
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A roundup of manufacturing news from Gilead Sciences, Seagen (formerly Seattle Genetics), Lupin Pharmaceuticals, Enzyvant.

FDA OKs Gilead’s CAR T-Cell Therapy Mfg Facility
The Food and Drug Administration (FDA) has approved commercial production for Kite’s, part of Gilead Sciences, new CAR T-cell-therapy manufacturing facility in Frederick, Maryland. The site will produce Kite’s FDA-approved CAR T-cell therapy used to treat blood cancer.

The Maryland site joins Kite’s existing manufacturing facilities in Southern California and Amsterdam, Netherlands. The company estimates its network capacity will be increased by 50%.

Kite began construction of the 275,000-square-foot facility in Maryland in 2019. The site has unfinished space to add future capacity, is purpose-built for cell-therapy manufacturing, and incorporates increased automation.

The company anticipates having more than 400 employees working at the Maryland site by the end of 2022.

Source: Gilead Sciences and Kite


Seagen To Build New Biomanufacturing Facility
Seagen (formerly Seattle Genetics), a Bothell, Washington-headquartered biopharmaceutical company, has announced plans to build a new biomanufacturing facility in Everett, Washington.

The 270,000-square-foot facility will be built north of the company’s US headquarters in Bothell, Washington. Seagen expects to have the facility operational in 2024 and ultimately employ up to 200. The facility will provide both clinical- and commercial-scale manufacturing.  The new facility will add to Seagen’s existing manufacturing site in the Bothell area.

Source: Seagen


FDA Cites Lupin’s API Mfg Facility 
The US Food and Drug Administration (FDA) has issued four observations in a Form 483 after concluding an inspection at Lupin Pharmaceuticals’ Tarapur active pharmaceutical ingredient (API) manufacturing facility in Mumbai, Maharashtra, India.

The inspection was carried out between March 22, 2022 and April 4, 2022. The company says it will address the observations to the FDA’s satisfaction.

Source: Lupin


Enzyvant To Build Regenerative Medicines Mfg Facility
Enzyvant, a commercial-stage biopharmaceutical company with a focus on regenerative medicines for rare diseases, announced plans to develop a cGMP regenerative medicine manufacturing facility in Morrisville, North Carolina.

The development of the 25,972-square-foot facility is expected to begin this summer (2022) and take approximately two and a half years to complete once construction begins. Enzyvant currently has research and development offices in Durham, North Carolina.

The new manufacturing facility is being co-developed by and operated with Sumitomo Pharma, which owns Enzyvant’s immediate parent company, Sumitovant Biopharma.

Sumitovant Biopharma was created with the $3-billion acquisition in 2019 by Sumitomo Dainippon Pharma of several “vant” or therapeutically focused subsidiaries of Roivant Sciences, a New York-based biopharmaceutical and healthcare company. Sumitovant operates as a wholly owned subsidiary of Sumitomo Dainippon Pharma and is the parent company of the five biopharma companies for which Roivant transferred its ownership interest: Enzyvant, Myovant Sciences, Urovant Sciences, Altavant Sciences, and Spirovant Sciences.

Source: Enzyvant