A roundup of manufacturing news from Amgen, Strides Pharma, Incyte, and Jaguar Gene Therapy.

Amgen Breaks Ground on $365-M Packaging Plant
Amgen has broken ground on a new final product advanced assembly and packaging plant in New Albany, Ohio.

The plant is expected to be operational by 2024. The new site, now known as Amgen Ohio, will be led by Sandra Rodriguez-Toledo, Vice President of Site Operations at Amgen Ohio.

Amgen first announced the plans for construction and the $365-million investment for the plant in July (July 2021). At full capacity, Amgen plans to hire up to 400 full-time staff, including technicians and engineers, along with quality assurance, quality control, administrative, and management positions.

Source: New Albany, Ohio government

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Strides Pharma To Acquire Former Endo Mfg Plant
Strides Pharma, a Bengaluru, India-headquartered pharmaceutical company and contract manufacturer, plans to acquire and build out a former drug-product manufacturing plant of Endo Pharmaceutical in Chestnut Ridge, New York.

The company plans to invest $42 million in the 200,000-square-foot, multi-dosage facility, retain more than 215 of its employees, and add an additional 40 jobs. The facility at Chestnut Ridge has an annual capacity of 2 billion units across semisolids, liquids, nasal sprays, and oral solids and is registered with the Drug Enforcement Administration. The facility will manufacture both brand-name and generic drugs for Strides’ own distribution and marketing as well as for others as a contract manufacturer.    

Source: New York Governor’s Office

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Incyte Suspends Distribution of Eczema Drug for Mfg
Incyte, a Wilmington, Delaware-based bio/pharmaceutical company, has suspended distribution of select batches of Opzelura (ruxolitinib) cream, a drug for treating atopic dermatitis (i.e., eczema) due to a small quantity of active pharmaceutical ingredient not being completely dissolved, resulting in a gritty texture.

The company received three product complaints for this issue and distribution of the affected batches have been suspended. Incyte reports that at this time (as reported on November 2, 2021), it has no commercial supply issues. Sixty-gram tubes of Opzelura remain available for distribution, and additional batches of the product continue to be manufactured. The company is conducting a root cause analysis in all batches to ensure continued product quality and supply.

Source: Incyte

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Jaguar Gene Therapy Plans Gene-Therapy Mfg Facility
Jaguar Gene Therapy, a Lake Forest, Illinois-based gene-therapy company, has announced plans for a commercial gene-therapy manufacturing facility in Durham, North Carolina.

The 174,000-square-foot facility will be located approximately 20 miles from Jaguar’s existing Process Sciences Laboratory in Cary, North Carolina. The facility will support future clinical and commercial production of the company’s initial programs including those in galactosemia, a rare, hereditary disorder of carbohydrate metabolism; autism; and Type 1 diabetes.

Jaguar says it expects to create at least 200 jobs over the next several years as part of this expansion. The company says it will continue existing CDMO partnerships and consider adding to its third-party network as needed to ensure dual sourcing and uninterrupted supply.

Source: Jaguar Gene Therapy