Capacity increases but demand shrinks in bioproduction
expand an average of 48 per cent over the next five years for
mammalian and microbial production systems, according to an
However, one of the critical issues that could hold up expansion is access to trained staff, according to BioPlan Associates, which published the report.
The projection suggests that industry's current five-year projection of production capacity expansion is now significantly lower than in 2003. In that year, the first survey's five-year projection indicated capacity would expand 69 per cent by 2008.
The findings are based on an annual survey of production by biotherapeutic developers and contract manufacturing organisations (CMOs).
"A major factor impacting production capacity expansion over the next five years will be the lack of trained and experienced production staff," according to Eric Langer, president and managing partner at BioPlan Associates. "In fact, nearly 40 per cent of the respondents to the survey indicated this would be a critical issue."
The report found that for CMO respondents, another major factor is expected to be lack of financing for production expansion (indicated by 52 per cent of CMO respondents). Key areas to address to avoid capacity constraints included: optimising cell culture systems to increase upstream performance (noted by 54.2 per cent of respondents) and improving downstream purification performance (43.8 per cent).
According to Howard Levine, of BioProcess Technology Consultants, a co-author of the report, biopharmaceutical developers have been investing in large-scale production. "Of the respondents engaged in biopharmaceutical manufacturing using mammalian cell culture, approximately 11 per cent indicated their production capacity was greater than 75,000 litres [in the latest survey]," he said. In 2002-3, only three companies had greater than 50,000 litres of mammalian cell culture capacity.
Recently, overall capacity utilisation by biopharmaceutical developers and contract manufacturers has declined, according to the report.
In 2005 use of existing capacity decreased 8 per cent compared to 2003. The decrease is a result of continued industry expansion, and improvements in yield at existing facilities. Despite this, some segments of the industry, including larger biopharmaceutical developers, continue to experience capacity constraints.
"In addition to industry expansion, a significant factor reducing the demand on capacity is that biopharmaceutical developers are seeing results from efficiency-based R&D aimed at producing greater yields," noted Langer. "This has two effects. It can open existing capacity for organisations like CMOs, and it can reduce the requirements for additional capacity for producers who can expand into the extra capacity generated by the efficiencies."
Capacity utilisation for all biomanufacturers using mammalian cell culture systems is currently 68.8 per cent, said BioPlan, while capacity utilisation for microbial fermentation is 60.5 per cent. For comparison, the US Federal Reserve Statistical Release showed that capacity utilisation for all US industries in July 2005 was 79.7 per cent.