Industry standardisation is the development and application of standards across companies and suppliers, to allow for the manufacture of interchangeable parts.
Custom-made manufacturing can incur long lead times and consequently compromise supply chain security, said PM Group operations consultant David Wolton at the BioProduction Congress in Dublin last month.
“We want all biopharmaceutical companies to use the same design,” said Wolton, who urged industry delegates: “Don’t be too ambitious, just standardise your buffer bags…everything else will cascade down from that.”
Many more buffer bags – which store stabilising liquids for biomanufacturing – are used in the biomanufacturing process than bioreactor bags, and can take up ten to 20 percect more space in warehouses, said Wolton.
A homogenous bag design allows for mass production and off the shelf delivery times, which reduces firms’ warehouse storage requirements, he said.
“If all the companies in the world start buying the same buffer bag…you would only need a week’s worth of supply in your warehouse, because everything else is off the shelf,” said Wolton.
PM Group has been working alongside the BioPhorum Operations Group (BPOG) to focus the standardisation of single-use designs initiative for connection types, bag dimensions, tubing type and dimensions, Wolton said.
“The one we have issue with is bag dimensions…I think that will be incredibly difficult to broker an agreement, and it’s quite a way off,” he added.
Wolton said while industry supports the concept of standardisation, determining a uniform design is a timely process.
“Everybody wants standardisation, they just want it their way,” he said.
Biopharma-Reporter contacted several end users including Pfizer and Amgen, which declined to comment.
A number of considerations, including intellectual property (IP) and unbiased, third-party involvement, must be addressed when designing a standardised bag, according to Wolton.
“Whoever decides [on the design] has to be independent of the end users…they also have to be independent of the suppliers,” he said.
Further, the designs must not have any IP associated with them, he told delegates.
“All of these designs must be available to everybody, if companies want to copy them, they can,” he said.
The solutions provider must also have a sustainable business case, to be able to cope with changing needs over time, he added.