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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