Facility Design and Engineering

GSK will invest £400 million (US$532 million) in a new Cambridge, UK, R&D center, relocating from Stevenage amid second quarter earnings and a cost-savings plan.

Scholar Rock’s apitegromab is awaiting a US manufacturing facility resolution, which may impact the therapy’s European review, for which clinical assessment has been completed.

With the closing of an acquisition, ROIS adds high-potent fill/finish and lyophilization capabilities to support biologics and ADC pipelines, addressing global supply and scalability challenges.

The hub will integrate the company’s manufacturing and R&D in China to streamline CAR-T development while addressing scalability and accelerating regional access to advanced therapies.

Green chemistry is emerging as a strategic lever for biopharma manufacturing, enabling safer processes, efficiency gains, and long-term competitiveness.

Johnson & Johnson reinforces its long-term domestic investment strategy with a new $2 billion biologics facility in Wilson, North Carolina, further elevating the state’s role as a global life sciences hub.

Biomanufacturing is shifting toward more resilient and digitized networks for enhanced supply security amid global and supply-chain volatility.

Samsung Biologics’ Maryland acquisition signals a major push into US biologics manufacturing, reshaping the company’s capacity strategy and supply chain resilience.

Manufacturing biologics is a complex task. Mitigating risk early in the design of manufacturing facilities and the qualification of equipment minimizes future complications.

AstraZeneca’s $2 billion investment in its Maryland facilities will expand domestic biologics and rare disease manufacturing and strengthen US drug supply chains.

Optimizing FDA 483 responses with strategic CAPA creates resilient quality compliance in biopharma manufacturing.

Automated facility upgrades for cell therapy enhance quality assurance, ensure regulatory compliance, and boost operational efficiency by minimizing manual risks.

Strategic AI integration in bio/pharma manufacturing enhances GxP compliance, quality, and operational efficiency through robust governance and risk management.

Third-party ICMC certification verifies multi-modality manufacturing readiness, meeting US and EU standards for advanced genetic therapies.

The new spinning plant to be built in Nobeoka City, Miyazaki, Japan will produce hollow-fiber cellulose membranes, expanding production of the virus removal filters.

The company’s intent is to establish Merck Wilmington Biotech as the future United States home for producing Keytruda for US patients.

The 6000-square-foot facility will provide cell therapy developers the support they need to transition to CGMP manufacturing, and an expanded footprint of the new center is expected to open in Philadelphia later in 2025.

With the investment, AstraZeneca will establish a second global strategic R&D center in Beijing as well as support major research and manufacturing agreements to further advance life sciences in the country.

Curia plans to expand its sterile fill/finish capabilities at its Glasgow, UK, site and gives updates on an ongoing expansion at its Albuquerque, NM, site.

Being fully versed on the ins and outs of design quality can improve the project design phase life cycle.

Prior to this announcement, Rentschler announced in September 2024 it would be launching an expanded service offering at its advanced therapies site in Stevenage, UK, which is now being shut down.

This is the latest facility launch for BioDuro, following a kilogram laboratory and compound management center, both on the same site, in October 2024.

With the DKK 8.5 billion (US$1.2 billion) investment, Novo Nordisk will build a new modular and flexible production facility in Odense, Denmark, to produce multiple products for rare diseases.

The company will add a new laboratory facility at its Shanbally, Co. Cork, Ireland, manufacturing site.

The European Commission’s approval of the Catalent acquisition by Novo Holdings includes the related acquisition of three manufacturing sites by Novo Nordisk, which is also acquiring the Czech Republic manufacturing site of Novavax for $200 million.