Facility Design and Engineering

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.

Lilly will expand its recently acquired manufacturing facility in Wisconsin with a $3 billion investment, and Amgen will expand its North Carolina facility with a $1 billion investment.

Operating in an aging facility and/or utilizing outdated equipment may lead to drug shortages and high operating costs.

Modular and replication strategies are being utilized to meet growing demand for CDMO facilities.

With FDA's clearance, Kedrion can manufacture Ryplazim (plasminogen, human-tvmh), the first and only FDA-approved therapy for treating PLGD-1, at its Bolognana, Italy, site.

The company officially launched new production suites, a revamp of its development labs, and more at its Thousand Oaks, Calif., cell therapy manufacturing facility.

The investment will allow Sanofi to strengthen antibody bioproduction at its Lyon Gerland site in France.

The new European facilities located in German, Italy, and Lithuania will specialize in drug discovery and R&D services.

Under a £15.7 million (US$20.7 million) investment, SEKISUI has expanded its UK site for clinical-grade drug substance manufacturing.

With financing led by OrbiMed, Novo Holdings, and Jeito Capital, Alentis Therapeutics will develop a pipeline of Claudin-1-targeted ADCs to treat solid tumors.

Avantor has launched its new, expanded Innovation Center in Bridgewater, NJ, with integrated workflows under one roof and purpose-built collaboration spaces.

With the launch of the Institute for Cell Therapy Discovery and Innovation, the MD Anderson Cancer Center will bring together expertise in developing cell therapies for cancer, autoimmune diseases, and infections.

The establishment of this new center aims to expedite R&D processes, reduce costs, and potentially lead to accelerated discovery of new candidate therapies.

The new center's design will prioritize integration of the entire supply chain, with the aim of accelerating product development and autonomous production capacity in alignment with EU priorities.

Lilly has increased its manufacturing investment for biologics in Limerick, Ireland, by $1 billion while launching its new $800 million facility in Kinsale.

During a presentation at the PDA/FDA Joint Regulatory Conference, Nicholas Violand of Johnson & Johnson and Paul Palmer of Paul R. Palmer Limited discussed how aging facilities can impact the quality of pharmaceutical products.

This is the company’s largest single investment in the Sweden Biomanufacturing Center, in Södertälje, which opened in 2021.

With a $15 million fund-raising goal, US Specialty Formulations plans to invest in expanding its biopharma facility in Allentown, Pa.

BioIVT has launched new cleanroom manufacturing space using Germfree’s technology that boosts its cell and gene therapies development capabilities.

Scorpius Holdings expects to launch its first CGMP campaign for mammalian-based biomanufacturing in the 2024 third quarter.

BeiGene has invested $800 million into a new biologics manufacturing facility in Hopewell, NJ, which also houses its clinical R&D capabilities.

The company plans to invest approximately €900 million (US$983 million) to expand its peptide platform at its Colorado, US, site and in Europe.

Novo Nordisk plans to invest $4.1 billion in a second fill/finish manufacturing facility in Clayton, N.C., boosting its current 2024 investments into production to $6.8 billion.

The $58 million investment has resulted in a 72,000-square-foot facility with a dedicated LC–MS space and molecular suites and will bring as many as 350 new jobs onto the campus.

AGC Biologics has completed an expansion at its Copenhagen, Denmark, site, which doubles its bioreactor capacity for mammalian-based cell culture.

FUJIFILM Diosynth Biotechnologies CEO Lars Petersen highlights the company’s strategic goals and meeting market demand for mammalian cell culture capacity.

This new facility will allow AstraZeneca to offer full manufacturing processing for antibody drug conjugates.

ADC manufacturing facilities are requiring more stringent containment requirements as well as advanced analytical detection.

Memel Biotech aims to offer a range of services from discovery through to formulation for preclinical through to late-stage clinical and commercial production of advanced therapies.

With the Vacaville, Calif., site acquisition, Lonza gains one of the largest biologics manufacturing sites for mammalian cell-based therapeutics.