Large volume production is a must for the cell therapy sector according to ATMI, which claims the latest addition to its single-use bioreactor range can help manufacturers overcome the GMP hurdles that hinder commercial scale-up.
The new Integrity Xpansion bioreactors – launched at the Cell Therapy Manufacturing Conference in Brussels, Belgium this week – feature a 2-D multiplate design that offers the same cell environment as standard multitray setups but, said ATMI, has been developed to support large-scale production.
Jose Castillo, ATMI’s global director of cell culture technologies, said: “It is essential that cell therapies can be made efficiently and effectively on a large scale for them to reach the market.
“Yet, it can be a challenge to achieve GMP standards during large-scale production because of a lack of efficient cell culture technologies — many of which can lead to bottlenecks and prohibitive costs.
The reactors can house 180 plates with a surface area of 11 sqm spaced 1.6mm apart in a unit 60cm high and 35cm in diameter which, ATMI claims, represents a ‘dramatic’ reduction in the factory floor space required compared with other bioreactor systems with the same capacity.
The unit’s closed design also increases the speed and likely of success of commercialisation according to ATMI, which suggested that because critical cell culture parameters do not change using Xpansion systems the risk of failure during process scale-up is mitigated.
ATMI claims the combined increase in scale-up speed and reduction in upstream and downstream processing steps cuts the number or operations required during manufacture and hence the “cost of goods can successfully be reduced by up to 40 per cent.”
ATMI’s life sciences business has grown in 2011. According to its latest SEC filing revenue for Q3 increased 32.8 per cent to $9.2m driven, it said, “by stronger demand for our single-use technology solutions and royalties from intellectual property licensing agreements.”
However, this is still a fraction of the contribution of its core microelectronics business with generated $85.8m for the quarter, down some 2.2 per cent on the year earlier period.