Europe to witness biopharma capacity jump

According to a new report by BioPlan Associates, biopharmaceutical manufacturing capacity will expand by an average of 46 per cent worldwide over the next five years for mammalian production systems. The most significant jump will be witnessed in Europe, where the average increase will reach 66 per cent. In comparison, US manufacturers will only increase capacity only 36 per cent. This projected growth is despite the fact that overall capacity utilisation by the biopharmaceutical industry has continued to decline since 2003, as a result of continued industry expansion, improvements in yield at existing facilities, and efficiencies associated with production. According to figures gathered by BioPlan, over the past four years, the per cent of operating capacity at biopharmaceutical manufacturing facilities has declined by 9 per cent annually for mammalian cell culture systems, and by 13 per cent for microbial fermentation. "Capacity utilisation has been particularly weak for US manufacturers using microbial fermentation systems. As a comparison, the US Federal Reserve Statistical Release showed that capacity utilisation for all US industries in March 2008 was 80.5 per cent​," said to Eric Langer, president and managing partner at BioPlan. However, there are certain segments of the industry in particular, including larger biopharmaceutical developers, that continue to experience capacity constraints, and are thus driving the demands for capacity expansion. "A major factor impacting production capacity expansion over the next five years will be the need for improved downstream purification performance​," explained Langer. The firm recently a released report titled: 5th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production​, following an analysis of worldwide biomanufacturing trends, incorporating data from 126 industry suppliers, 434 biopharmaceutical developers and contract manufacturing organisations (CMOs) from 32 countries. Langer indicted that over 54 per cent of European respondents and 46 per cent of US respondents to the survey indicated that improved downstream purification performance would be a "critical issue​" over the next few years. The report also found that for CMO respondents, the need for downstream improvements was an even greater factor than for the pharmaceutical companies, with downstream bottlenecks being indicated as a "major capacity constraint​" by 46 per cent of CMOs compared with 28 per cent of drug innovators. In addition, other key areas of biopharmaceutical manufacturing that would be needed in order to address to avoid capacity constraints included the need for better disposable products, optimising upstream performance, and standardising international regulatory processes, said BioPlan.