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

Patricia Van Arnum
Continuing growth in biopharmaceutical product revenues and pipeline candidates bodes well for the contract biologics market. Worldwide revenues for biopharmaceutical products is estimated to exceed $65 billion in 2007, and the proportion of pharmaceutical revenues from biotechnology drugs is estimated to surpass 10% of the total market (1).

Growth in contract manufacturing

Global spending on biopharmaceutical contract production was estimated at $2.1 billion in 2006, according to a recent study by HighTech Business Decisions (San Jose, CA) (1). This level is expected to rise to $2.8 billion in 2008 and $4.3 billion by 2009.

A 2500-L mammalian cell culture bioreactor in one of Laureate Pharma's manufacturing suites. Photo: Laureate PHARMA
On a supply level, between 2004 and 2008, worldwide contract manufacturing capacity for biopharmaceuticals is expected to grow by approximately 40% (1). Measuring capacity in tank liters under the two broad categories of microbial fermentation and mammalian cell culture, the study shows that biopharmaceutical contract manufacturers' installed capacity for microbial fermentation will reach 300,000 tank liters by 2008, an increase of 15% from two years ago. Biopharmaceutical contract manufacturers also plan additional follow-on capacity expansions throughout the next five years. (This estimate includes capacity for biopharmaceutical production only; microbial capacity that is used for microbially produced small molecules or products such as antibiotics is not included.)

Market growth for monoclonal antibodies
Worldwide outsourced mammalian cell-culture capacity is expected to reach 670,000 tank liters by 2008, a 21% increase from two years ago, according to HighTech Business Decisions (1). As with microbial-fermentation capacity, biopharmaceutical contract manufacturers plan follow-on capacity expansions during the next five years.

Inside Big Pharma: Ramping up internal biologics capacity
Capacity utilization. Biopharmaceutical contract manufacturers report average utilization rates of 72-87% for microbial fermentation production capacity. Average capacity utilization rates for mammalian cell-culture production vary from 65% to more than 90%. In both instances, capacity utilization rates are expected to increase during the next two years and then drop slightly as current and planned capacity expansions come on line (1).

Investments by top players

Several top CMOs are expanding capacity. Based on revenues, the top biopharmaceutical CMOs include Avecia Biologics (Billingham, United Kingdom), Boehringer Ingelheim (Ingelheim, Germany), Diosynth Biotechnology (Morrisville, NC), Lonza (Basel, Switzerland), and Sandoz (Holzkirchen, Germany), according to HighTech Business Decisions.

Lonza. Reflecting strong growth in its biopharmaceutical business, Lonza is investing in microbial and mammalian cell-culture production. Following its $460-million acquisition of Cambrex's (East Rutherford, NJ) bioproducts and biopharmaceutical business in February, Lonza named Hopkinton, Massachusetts, as the global US headquarters for its microbial biopharmaceutical business and announced plans to invest more than $30 million in its Hopkinton site to support growth plans for microbial process development and manufacturing. The Cambrex acquisition gave Lonza additional biopharmaceutical services capabilities and small-and mid-scale microbial manufacturing capacity to complement existing microbial capacity in Visp, Switzerland. Lonza started producing current good manufacturing practices (CGMP) batches at a new 15,000-L microbial biopharmaceutical line in Visp earlier this year, and a second line is now operational.


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