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BIO INNOVATION NOTES now often optimized by drug-like screening using micro-wells as model bioreactors, and bioprocesses better-monitored and -controlled using new and improved sensors and control systems. Increases in expression yields, besides reducing costs and making manufacturing simpler, are having other impacts in the biopharmaceutical industry: • CMOs are now offering commercial monoclonal antibody scale-up services using 500 L, rather than 2,000 L, bioreactors. • Many companies with large banks of ≥10,000 L bioreactors increasingly have excess capacity. • Legacy facilities are being decommissioned, refurbished, being used less, and being used to provide CMO services. • More large biopharmaceutical companies are considering providing CMO services to use this manufacturing capacity. Ever-improving process yields, particularly when combined with other recent major advances in bioprocessing, such as the adoption of single-use rather than stainless steel systems for manufacture, are providing increasing efficiencies in bioprocessing, dramatically reducing the scale and costs for biopharmaceutical manufacture. Combined with advances in expression systems engineering (such as cell line development, media optimization, and metabolic engineering), we expect to see continued increases in volumetric titres and yields. Figure 1: 2013 Range Of Titres For Mabs Obtained At Various Production Scales <10 mcg/L 0% 0% 0.01 g/L to 0.1 g/L 1.2% 4.7% 5.6% >0.1 g/L to o.2 g/L >0.2 g/L to 0.5 g/L 3.5% 0% 9.3% >0.5 g/L to 1.0 g/L 11.1% 12.8% >1.0 g/L to 1.5 g/L 19.4% 14.0% >1.5 g/L to 2.0 g/L 26.4% 14.0% >2.0 g/L to 2.5 g/L Commercial Scale Production Average Titre 2.29g/L 11.1% 15.1% >2.5 g/L to 3.0 g/L 9.7% >3.0 g/L to 5.0 g/L 16.3% 9.7% 7.0% >5.0 g/L to 10 g/L 5.6% >10 g/L Late-Stage Clinical Production Average Titre 2.68g/L 2.3% 1.4% Late-Stage Clinical Scale Production Commercial Scale Production Survey Methodology: The 2013 Tenth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production yields a composite view and trend analysis from over 300 responsible individuals at biopharmaceutical manufacturers and CMOs in 29 countries. The methodology included over 150 direct suppliers of materials, services, and equipment to this industry. This year's study covers such issues as: new product needs, facility budget changes, current capacity, future capacity constraints, expansions, use of disposables, budgets in disposables, trends in downstream purification, quality management and control, hiring issues, and employment. The quantitative trend analysis provides details and comparisons of production by biotherapeutic developers and CMOs. It also evaluates trends over time and assesses differences in the world's major markets in the U.S. and Europe. If you want to learn more about the report, please go to bioplanassociates.com. 22 LifeScienceLeader.com September 2013