Single-use vendors play vital role in biopharma supply chain, says Sartorius
WuXi’s biologics plant in Wuxi (near Shanghai), China opened in 2012 with the firm claiming it was the first in the country to comply with European and US good manufacturing practices standards (GMP).
Last week, the International Society for Pharmaceutical Engineering (ISPE) in Las Vegas, presented an award to Sartorius Stedim Biotech (SSB) for its role in the design and construction of the plant.
While SSB is a vendor of disposable bioreactors and systems, the firm has been offering integrated bioprocess solutions to the industry for over five years, spokesperson Miriam Monge told Biopharma-Reporter.com, due to increasing demand from clients.
“We are true partners working with our clients,” she said. “The biomanufacturers are effectively outsourcing part of their quality and supply chain to us and as such this close relationship is vital.”
Such vendor-led design is the cause of industry’s advent of single-use, she added, describing the impact of disposables on facility design as a “total game changer.”
“The opportunities to completely revisit your facility layout, considerably reducing footprint, reducing higher classification areas, and - contrary to what people may think - enabling a more sustainable facility with strongly reduced water usage are just enormous.”
Eggs in one bioreactor?
Other companies including GE Healthcare offer facility planning and design services, but speakers from Big Biopharma firms Pfizer and Merck & Co. told delegates at BioProcess International in Boston yesterday that they were concerned about ceding control of systems to such vendors while retaining accountability.
However, Monge said such relationships formed a strategic part of the supply chain and helped cut costs.
“We use process modelling and simulation tools to evaluate with our client the best mix of technologies for their given process, our aim is to ensure optimized throughput and lowest Cost of Goods for our client.”
She added: “Depending on the scale and type of process this may well mean implementation of hybrid solutions so yes the flexibility is always there.”
For the nine months ending September 30 2014, the firm reported a 14.6% increase in orders in its Bioprocess Solutions Division year-on-year to €460m ($585m), while sales also rose by 17.2% to €445m.