Sancilio opens batch manufacturing plant
The new 2,000 square foot facility, which is located next to the firm’s existing laboratory space, is compliant with US Food and Drug Administration (FDA) good manufacturing practice (GMP) standards. The plant also features an extensive range of packaging and labelling facilities suitable for small scale manufacturing runs.
Speaking at the facility’s launch, company CEO Fred Sancilio, said that the key feature of the set up, which holds a Drug Enforcement Agency (DEA) licence for the production of schedule 2, 3 and 4 drugs, is its capacity for rapid and flexible manufacturing turnaround.
These thoughts were echoed by SCI vice president Nealie Newberger, who said that: “we anticipate that the addition of small batch contract manufacturing to our roster of services strategically positions the company as a full-service pharmaceutical enterprise.”
Sancilio’s move into the contract manufacturing area is in keeping with a general trend within the US contract research industry (CRO) that has seen companies begin to offer more comprehensive service offerings in a bid to compete with the booming Asian CRO sector.
Whether such efforts will help win back research contracts for US players remains to be seen, however, the perceived wisdom among industry analysts is that emerging markets will continue to attract the major research contracts for the foreseeable future.
Earlier this year for example a Frost and Sullivan report predicted that the Asian CRO sector, which generated revenues of $1.2bn in 2006, will be worth around $2bn by 2010.
The study forecast that while India and China would maintain their dominance, CROs in countries like Australia, Taiwan, Hong Kong and South Korea, rather than the US, will challenge this position.
Existing R&D and analystic set-up
SCI, which was set up in 2006, already provides a range of research and analytic services to drugmakers. Foremost among these is the firm’s method development and formulation services, which are designed to assess early stage manufacturing process ahead of industrial scale up.
SCI also provides an extensive suite of stability testing and finished product testing services, which it believes can help drugmakers significantly reduce development and manufacturing costs.
