Mfg News: Amgen, Pfizer, Novo Nordisk, Moderna & More
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The latest manufacturing news from Amgen, Pfizer, Novo Nordisk, Moderna, Shanghai Pharmaceuticals, and Expression Therapeutics.

Amgen Investing $100 M in Irish Mfg Facility
Late last month (December 2021), Amgen announced an investment of $100 million for the construction of a new vial-filing line and new site infrastructure at its manufacturing plant in Dun Laoghaire, County  Dublin, Ireland.
 
The Dun Laoghaire plant specializes in formulation, aseptic drug-product filling, lyophilization, packaging as well as analytical testing using onsite laboratories. The Amgen plant in Dun Laoghaire is celebrating its 10th anniversary in 2022 and currently employs 670 staff.
 
Construction on the new vial line has already begun and is due to be completed and fully operational by 2024.

Source: IDA Ireland


Pfizer Opens Clinical Gene-Therapy Mfg Facility
Pfizer reported last month (December 15, 2021) the opening of a new $68.5-million clinical manufacturing facility for gene therapies in Durham, North Carolina. The Durham facility is part of an $800-million investment over the past six years to build three scalable, gene-therapy manufacturing facilities to support Pfizer in gene therapy research, development, and manufacturing.

The Durham facility will house Pfizer’s BioTherapeutics Pharmaceutical Sciences Group, which is responsible for the manufacturing and analytical release of clinical supplies for Pfizer’s gene-therapy and biologics portfolio. The facility is expected to create more than 50 new jobs in the coming years, in addition to the approximately 40 employees who will relocate from Pfizer’s Chapel Hill, North Carolina, site.

Source: Pfizer


Novo Nordisk To Acquire CDMO Ritedose, Other Mfg News
Novo Holdings, the holding company of the Novo Group comprising Novo Nordisk and Novozymes, has agreed to acquire Ritedose, a Columbia, South Carolina-based CDMO of aseptic manufacturing and liquid packaging of respiratory and ophthalmic products using blow–fill–seal technology, from AGIC Capital and Humanwell. In addition, Ritedose develops and markets its own portfolio of generic drugs and is an emerging player in the outsourced sterile compounding market. The transaction is subject to customary closing conditions and is expected to close in the first quarter of 2022.

In a separate deal, Novo Holdings has invested EUR 86 million ($97 million) in 21st.BIO A/S, a new Danish bioindustrial scale-up company. The company was founded in 2020 and currently operates in Denmark and California. The focus areas of 21st.BIO include proteins and peptides for the food, materials and agricultural industries. The technology platform of 21st.BIO originates from selected parts of the platform of Novozymes, Novo Nordisk’s industrial biotechnology and enzymes company.

In addition, Novo Nordisk announced last month (December 17, 2021) that a contract manufacturer filling syringes for Wegovy (semaglutide) pens for the US market temporarily stopped deliveries and manufacturing following GMP issues. Wegovy is a weight-management product.

As a consequence, Novo Nordisk does not expect to be able to meet demand in the US in the first half of 2022, and few new patients are expected to be able to initiate treatment. Novo Nordisk expects to be able to meet demand in the US in the second half of 2022.

Source:  Novo Nordisk (Ritedose), Novo Nordisk (21st.BIO A/S), Novo Nordisk (Wegoy)


Moderna, Australia in Talks for Vaccine-Mfg Facility
Moderna has formed an agreement in principle with the Australian government to build a messenger RNA (mRNA) vaccine-manufacturing facility in Victoria, Australia, The contemplated framework would build the foundation to support Australia with direct access to rapid pandemic response capabilities and to provide access to Moderna’s vaccines in development for respiratory viruses.

Source: Moderna


Shanghai Pharmaceuticals To Build Continuous Mfg Lab
Shanghai Pharmaceuticals, a Shanghai-based pharmaceutical company, and Syntegon, a Waiblingen, Germany-based provider of process and packaging technology (formerly the Packaging Division of the Bosch Group), have signed an agreement to build a laboratory for continuous manufacturing technology in China.

Source: Syntegon


Expression Therapeutics Opens Viral Vector Mfg Facility
Expression Therapeutics, Inc., a clinical-stage bio/pharma company developing cell and gene therapies has opened a new 43,000-square-foot cell and viral vector manufacturing facility in Cincinnati, Ohio. The company’s manufacturing subsidiary, Expression Manufacturing LLC, provides end-to-end research and development capabilities and early-phase and commercial-scale manufacturing of both GMP cell and viral vector products. The facility manufactures lentiviral and adeno associated viral vectors.

Source: Expression Therapeutics