CMOs Expand Biologics Manufacturing - Pharmaceutical Technology

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CMOs Expand Biologics Manufacturing
A surge in capacity in contract microbial and mammalian cell-culture is underway to meet rising production needs for biopharmaceuticals.

Pharmaceutical Technology

Earlier this year, Lonza began construction of its second large-scale mammalian facility in Singapore. The final build-out of the facility is expected to be completed and operational in 2011. The $350-million facility will have four mammalian bioreactor trains, each with a flexible capacity of 1000–20,000 L, inclusive of purification units.

In May 2007, Lonza broke ground for a new $300-million, 330,000-ft2 -facility for biopharmaceutical manufacturing technologies, support systems, and warehouses in Portsmouth, New Hampshire, where the company has commissioned its largest-scale mammalian cell-culture plant to date. Lonza also is adding a 5000-L bioreactor to the existing facility, which has 93,000 L of capacity.

The expansions at Portsmouth follow Lonza's acquisition of Genentech's (South San Francisco, CA) mid-scale mammalian biopharmaceutical production plant in Porriño, Spain, in late 2006.

Lonza further added to its biopharmaceutical toolbox with the acquisition of the "AggreSolve" technology and service business of Zyentia (Cambridge, UK). AggreSolve is an in silico protein-analysis platform that can be applied to solving the problems posed by protein aggregation. Lonza made the acquisition in August 2007.

Boehringer-Ingelheim. Boehringer-Inghelheim modernized and expanded high-yield fermentation processes for mammalian cell cultures at its biopharmaceutical production facility in Biberach, Germany. The project, which was first announced in 2005, was scheduled for completion this fall.

Avecia Biologics. In May 2007, Avecia Biologics (Billingham, United Kingdom) launched a new biotherapeutic protein production technology, "pAVEway." The technology enables microbial production (> 10 g/L) for therapeutic proteins such as vaccines, cytokines, and growth factors. In October, the company reported that it was investing £1 million ($2.1 million) to add a suite of biologics laboratories at its facilities in Tees Valley, United Kingdom to add 20% more research and development work based on the pAVEway platform.

Diosynth. Diosynth, the third-party manufacturing unit of Organon BioSciences (Oss, Netherlands), will be undergoing a change of ownership pending Schering-Plough's (Kenilworth, NJ) $14.4-billion acquisition of Organon BioSciences from Akzo Nobel (Arnhem, The Netherlands). Schering-Plough is acquiring Organon in part to expand its position in biologics. Organon BioSciences consists of Organon (human pharmaceuticals), Intervet (animal health), Nobilon (human vaccines ), and Diosynth. Schering-Plough received approval from the European Commission for the deal in October and hopes to complete the acquisition, which includes receiving US regulatory approval, by the end of 2007.

Other CMO expansions

Other CMOs are expanding. Wacker (Munich, Germany), which provides contract microbial manufacturing, is investing EUR 15 million ($22 million) at its biopharmaceutical operations in Jena, Germany. The first project doubles its manufacturing space by adding a new purification station to help ease bottlenecks. The station will operate under good manufacturing practices. The facility is scheduled to come on steam in 2009.

In the second project, Wacker is constructing a new building in Jena for process development and quality control. The building is scheduled for completion in late 2008 and will support the company's proprietary E. coli-based protein secretion technology.

SAFC (St. Louis, MO) plans to invest $29 million to expand its drug-substance capabilities in high-potency biologics at the Sigma-Aldrich facility in Jerusalem, Israel. The 50,000-ft2 high-potency fermentation expansion is scheduled for completion in the first quarter of 2009.

Laureate Pharma (Princeton, NJ) opened a new pilot plant for preclinical biopharmaceutical manufacturing in March. The plant is designed for process development, production, and purification of early-phase preclinical proteins

Startups for analytical services

The growth is biopharmaceuticals is also broadening applications in contract analytical services. Last month, NanoImaging Services (San Diego, CA) began offering high-resolution, three-dimensional transmission electron microscopy (TEM) imaging services to manufacturers of large-molecule biopharmaceuticals. "Although this technology is well-proven in the laboratory, we are the first to offer it as a commercial service," said Bridget Carragher, NanoImaging's chief operating officer in a company release.


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