Building Monoclonal Antibody Production

Monoclonal antibodies (mAbs) are increasingly important in the product portfolios of pharmaceutical companies, and contract manufacturing organizations (CMOs) are keeping pace by investing in mAb production.

Market opportunities

There are 418 biotechnology products either in human clinical trials or under review by the US Food and Drug Administration estimates the Pharmaceutical Research and Manufacturers of America (Washington, DC). mAbs account for 38% or 160 of these products and recombinant proteins and hormones account for 10% or 43 products (1).

The market for mAbs is projected to increase at a compound annual growth rate of 20.8% through 2010 (see Figure 1), and within Big Pharma, mAbs are excepted to contribute additional revenue of roughly $17.9 billion in 2010 (2).

Figure 1

Several drug majors recently have acquired companies with mAb product platforms or technologies. AstraZeneca's (London, UK) pending $15.6-billion acquisition of MedImmne (Gaithersburg, MD) provides the company with the first second-generation mAb, "Numax" (motavizumab), a follow-on product to "Synagis"(palivizumab) (2). The move follows AstraZeneca's acquisition of Cambridge Antibody Technology in 2006.

In April, Roche (Basel, Switzerland) bought Therapeutic Human Polyclonals (THP, Mountain View, CA) for $56.5 million. THP has a transgenic mammalian platform (using transgenic rabbits) for producing monoclonal and polyclonal antibodies. Roche has several commercial antibodies, including "MabThera" (rituximab), "Herceptin, " (trastuzumab), and "Avastin" (bevacizumab).

CMOs focus on mAb production

Goodwin Biotechnology Inc. (GBI, Plantation, FL) is completing an expansion of its GMP manufacturing capacity and process-development laboratories, which is in part fueled by pacts for mAb production. GBI is manufacturing a Phase II ovarian cancer antibody for the Menarini Group (Florence, Italy) and two mAbs for Thallion Pharmaceuticals (Montreal, Canada).

Lonza (Basel, Switzerland) is investing in a new production unit and development and analytical laboratories in Visp, Switzerland for large-scale production of antibody drug conjugates, which involve coupling a highly active chemical substance with a biotechnologically manufactured antibody. Construction of the commercial-scale plant began in 2006, and Stage I is expected to be on line in 2008 with an initial annual capacity of 100 kg. Lonza now is operating at laboratory-scale production and will bring small-scale pilot facilities on stream in 2007.

Earlier this year, Crucell (Leiden, Netherlands) and DSM Biologics (Herleen, Netherlands) reported yields of more than 10 g/L for mAbs using the "PER. C6" human cell line and are striving to reach yields of 20 g/L. The companies recently opened the Percivia PER. C6 Development Center in Cambridge, Massachusetts.

References

1. Pharmaceutical Research and Manufacturers of America, 2006 Report:Medicines in Development-Biotechnology (PhRMA, Washington, DC, August 2006), www.phrma.org/files/Biotech%202006.pdf.

2. S.King, "The New Pharmaceutical Value Chain: Biologics Set to Surpass Growth in Small Molecules, " Pharm. Technol. 30 Technology Outlook: APIs, Intermediates, and Formulation supplement, s6–s10 (2006).