Mfg News: Gilead, Takeda & Lupin

A roundup of manufacturing news from Gilead Sciences, Takeda and Lupin. Highlights below.

* Gilead Retroviral Vector Mfg Facility Gets FDA OK
* Takeda To End Mfg of Thyroid Drug Natpara
* Lupin Receives FDA Warning Letter for API Mfg Facility

Gilead’s Retroviral Vector Mfg Facility Gets FDA OK
Gilead Sciences reports that the US Food and Drug Administration (FDA) has approved Kite’s, a Gilead owned company, 100,000-square-foot retroviral vector manufacturing facility for cell therapies in Oceanside, California, for commercial production.

The site employs approximately 100 employees. The Oceanside site is part of Kite’s cell-therapy commercial manufacturing network that includes facilities in El Segundo, California, Amsterdam, the Netherlands, and a recently FDA-approved Maryland site.

Source: Gilead Sciences

Takeda To End Mfg of Thyroid Drug Natpara
Takeda says it will discontinue global manufacturing of Natpar/Natpara (parathyroid hormone), an injectable drug to treat hypoparathyroidism, a disorder of the thyroid when too little parathyroid hormone is produced that causes abnormal levels of calcium and phosphorus, at the end of 2024 due to unresolved supply issues that are specific to the product. As a result, Takeda will not re-commercialize Natpara in the US and will discontinue manufacturing Natpar globally.

Takeda says that until the end of 2024, its priority is to maintain treatment continuity for patients who are currently receiving Natpar/Natpara, subject to available supply. Beyond 2024, Takeda intends to supply available doses until inventory is depleted or expired.

Takeda has encountered supply challenges surrounding protein particle formation that are unique and specific to the drug. Over the past several years, the company says it has explored numerous ways to address the drug’s protein-particle issue to improve sustainable supply. Some of the specific steps have included: focused root cause analysis, computational modeling, evaluation and implementation of manufacturing process changes, and reformulation research and development. Separately, after receiving a Complete Response Letter from the US Food and Drug Administration earlier this year (2022), Takeda said it determined it cannot implement a solution to the rubber particle formation issue, which led to the US recall of the drug in 2019.

Source: Takeda

Lupin Receives FDA Warning Letter for API Mfg Facility
Lupin, a Mumbai, India-headquartered bio/pharmaceutical company, reported that it had received a Warning Letter from the US Food and Drug Administration following an inspection of its active pharmaceutical ingredient (API) manufacturing facility in Tarapur, Maharashtra, India. The FDA had inspected the facility from March 22, 2022 to April 4, 2022. The facility manufactures both fermentation-based and synthetic APIs.

The company says it does not believe that the Warning Letter will have an impact on disruption of supplies or the existing revenues from operations of this facility.

“We are committed to addressing the concerns raised by the U.S. FDA and will work with the U.S. FDA to resolve these issues at the earliest,” said the company in September 29, 2022 letter filed with the Bombay Stock Exchange and National Stock Exchange of India

Source: Lupin