The contract development and manufacturing organizations (CDMOs) is a wide and fragmented landscape. But of course some players are larger than others, and this week brings a trilogy of good news for some of the biggest companies operating in the biologics and advanced therapies space.
Beginning with Lonza, the world’s largest pure-play CDMO in terms of mammalian capacity, the Swiss firm has completed the first GMP product batch from its recently expanded manufacturing facility in Portsmouth, New Hampshire.
Lonza first announced plans for the $220 million single-use equipped facility back in 2021. The facility houses eight 2,000 L single-use bioreactors over an area of 3,000 square feet and will “service the growing need for small-scale manufacturing and to implement next-generation manufacturing technologies to support small- to mid-volume products through launch,” the firm told us at the time.
In a statement this week, Stefan Egli, head of Lonza’s Mammalian Business Unit, said the completion of the first batch “is a testament to our commitment to delivering industry-leading manufacturing services to our customers, highlighting our continued efforts to support our customers’ needs across their product lifecycle and meet growing market demand for the launch scale.
“The new 2,000 L asset will support small- to mid-volume products, such as innovative therapies targeting rare diseases, and provides the flexibility required for efficient product launches and sustainable lifecycle management across our manufacturing network.”
Samsung Biologics is the second largest biologics CDMO, with 604,000 L of manufacturing capacity through four plants at its Bio Campus I site in Songdo, South Korea.
The firm has seen a number of deals signed over the years to justify the huge mostly stainless-steel capacity, and this week announced a series of manufacturing deals with an undisclosed Europe-based pharma worth $668 million.
The contract will run through December 2031 and will contribute to the more than $4 billion in deals inked this year for the CDMO. In October, the firm announced its largest ever deal with an undisclosed single client: a $1.24 billion contract to produce biologics through December 2037.
“We are delighted to expand our partnership with the European pharmaceutical company toward our shared commitment to delivering high-quality biopharmaceuticals to patients,” said John Rim, CEO of Samsung Biologics. “As we further expand strategic collaboration with clients worldwide, we also make continued investments in our capabilities and manufacturing technologies.”
The company is building Bio Campus II in Songdo, which will begin with 180,000 L of capacity at plant 5, with room to add three more plants of the same size.
Finally, Japanese conglomerate Fujifilm last year announced plans to invest $200 million into its cell therapy businesses, including supporting an expansion at CDMO Fujifilm Diosynth Biotechnologies’ Thousand Oaks, California site.
The expansion is now complete, adding two independent production clean rooms and a development lab, which will up manufacturing capacity for client programs.
“The completion of the expansion at our California cell therapy facility demonstrates our ability to support the growing needs of our early-to-late-stage allogeneic customers and late-phase autologous customers for commercial cell therapies,” Lars Petersen, CEO of the CDMO, said. “As our industry realizes the promise of precision medicine, we are pleased to be at the ready to support production at our California facility, with the specialized skill and expertise of our team on-site.”
The completion coincided with approval by the EMA for the manufacturing of Atara Biotherapeutics’ Ebvallo (tabelecleucel; tab-cel), an allogeneic cell therapy approved in Europe in 2022 for Epstein‑Barr virus positive post‑transplant lymphoproliferative disease.
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