Single-use technologies have made headlines across the pharma/biopharma manufacturing space—with countless education sessions devoted to this very topic at trade shows across the world.
With this household name commonly darting across digital screens or cropping up in workplace discussions, the origin of single-use technologies may fade from memory as new innovations are introduced to the market.
But, on occasion, it is helpful to reflect how far we have come as we continue to make headway in this new space.
The Origins of Single Use
“Single use really came into its own in bioprocessing,” said Jerry Martin, Pharmaceutical and Life Sciences Consultant to PMMI and Chairman Emeritus of the Bio-Process Systems Alliance.
According to Martin, single use started with a company called Hyclone—which has since been absorbed in part by Thermo Fisher and another part by GE Healthcare. Hyclone was a supplier of serum for cell culture media.
“As the biotech industry was starting to move toward larger volumes and started to produce drugs in larger quantities, drug manufacturers wanted to buy serum in larger quantities,” explained Martin, which was before the move to serum-free culture media. “I think the first commercial-scale single-use system was at Hyclone.”
Hyclone was looking for ways to supply serum in bulk quantities, and they looked to the food industry, where bulk food is often packaged in plastic bags.
“They decided to go and buy a large-scale, food bag manufacturing line and bring it to their facility in Utah—packaging their serums in large bags as a way of shipping it,” said Martin.
After this point, the company needed to filter the serum and came up with the idea of doing the whole process in plastic disposable bags.
“When the drug manufacturers started to see this serum show up in plastic bags, they went: ‘Oh! That’s a really interesting idea. Can you just sell us the bags?’” Martin said, explaining that this was the start of single-use bags and filters.
After this point, people started wondering if they could do their bioreactor work in bags. The first single-use bioreactor bags were called ‘wave bags,’ which are still widely used. The difficulty for this particular bag was scaling it up larger than 500 liters. To go larger, experts went back to the traditional stirred tank design with a bag inside of it that acted as a liner, creating the first large scale stirred tank disposable bioreactors.
Motivations for Single-Use Technologies
The original motivation to utilize single-use technologies was to avoid cleaning the equipment.
The drug manufacturers started to realize that it was very difficult to understand the regulatory requirements for the following:
- How clean does the equipment need to be?
- How do they prove that the equipment is clean?
- What does ‘clean’ mean?
It was a lot easier to meet the regulatory requirements if companies started with clean, plastic material to begin with.
Once the drug manufacturers started using single-use technologies, “the FDA took a look at it and what they saw was that the fluid container (the bag) and the fluid transfer pathway (the tubing and the filters) was all pre-assembled and pre-sterilized, which eliminated a lot of manual steps where these components (when they were in stainless steel) had to be assembled in a clean room,” said Martin.
The FDA saw single-use technologies as a reduction in the risk of contamination and they soon started to encourage using it.
Soon thereafter, the driver for using single-use technologies changed. Originally, single use was to avoid cleaning the machines, then it later was seen as safer and more cost-effective.
PMMI, The Association for Packaging and Processing Technologies, represents the voice of more than 700 North American manufacturers of equipment, components, and materials for processing and packaging. PMMI co-produces Pharma EXPO – Nov. 6-9, 2016 – with the International Society for Pharmaceutical Engineering (ISPE).
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