Mfg News: Moderna, BeiGene, and Novo Nordisk

A roundup of manufacturing news from Moderna, BeiGene, and Novo Nordisk. Highlights below.

* Moderna Plans mRNA Mfg Facility in Canada
* BeiGene Breaks Ground on New Mfg, Clinical R&D Center
* Novo Nordisk Resumes Production of Obesity Drug

Moderna Plans mRNA Mfg Facility in Canada
Moderna has announced plans to build an mRNA vaccine manufacturing facility in Quebec, Canada, which will support a long-term partnership with the Canadian government to enhance pandemic preparedness.

Construction of the facility is expected to commence in 2022, with the facility expected to become operational by the end of 2024, subject to planning and regulatory approvals.

Once operational, the facility will produce a portfolio of mRNA vaccines against respiratory viruses, including COVID-19, seasonal influenza, respiratory syncytial virus, and other potential respiratory viruses, contingent on approval by Health Canada, the regulatory body of Canada. In the event of a future pandemic, facility could be activated on an urgent basis to support Canada with direct access to pandemic response capabilities with the capacity to adapt and adjust manufacturing to address viruses.

Moderna and the Canadian government signed a memorandum of understanding for the facility in August 2021. The partnership is expected to be finalized following approval of the final agreement by the Canadian government. As part of the ten-year partnership, Moderna is also expected to support research and development and other commercial collaborations in the country.

Source: Moderna

BeiGene Breaks Ground on New Mfg, Clinical R&D Center
BeiGene, a Beijing-based bio/pharmaceutical company, has broken ground on a US manufacturing and clinical R&D center in Hopewell, New Jersey.

The initial phase of construction will have approximately 400,000 square feet of dedicated commercial-stage biologic pharmaceutical manufacturing space, with capacity for up to 16,000 liters of biologics formula. BeiGene acquired the Hopewell property from Lincoln Equities Group in November 2021. The property has more than one million square feet of developable real estate for potential expansion.

BeiGene is commercializing a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. It also has collaborations for new product development with other companies, including Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021, BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody, tislelizumab in North America, Europe, and Japan. The companies later announced an option, collaboration and license agreement in December 2021 for BeiGene’s anti-cancer drug, ociperlimab, which is in in Phase III development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.

BeiGene currently has five offices in the US in the following locations: San Mateo, California; Emeryville, California; Cambridge, Massachusetts; Ridgefield Park, New Jersey; and Fulton, Maryland. Globally, the company has more than 30 offices.

Source: BeiGene

Novo Nordisk Resumes Production for Obesity Drug
Novo Nordisk provided an update on the contract manufacturing activities for its weight-management product, Wegovy (semaglutide). Last December (December 2021), the contract manufacturer temporarily stopped deliveries and manufacturing Wegovy pens for the US following GMP issues.

Novo Nordisk now reports that the contract manufacturer filling syringes has reinitiated commercial production. Novo Nordisk expects to make all Wegovy dose strengths available in the US during the second half of 2022. The company provided the update in its first-quarter earnings results.

Source: Novo Nordisk