Our over-consumption of plastic in everyday life has led to some Governments intervening, for example with a five pence ($0.08) carrier bag levy enforced in Wales and Northern Ireland in 2011, with the rest of the UK set to follow.
The plastics used in biomanufacturing may not end up floating in a canal like a discarded supermarket bag but the trend towards this type of disposable system has its own environmental impacts which “deserve a lot more investigation,” according to Dr David Santillo, a Senior Scientist at Greenpeace.
He told Biopharma-Reporter.com: “Currently, if certain plastics or combinations of plastics meet specifications for manufacturing operations, there is no incentive to look at alternative materials for bioreactors which may have better environmental performance.”
“Just because biomanufacturing has the promise of being the ‘guiding light on the horizon’ for pharma, it shouldn’t be exempt from the environmental scrutiny that is involved in all other industries,” he continued, adding “any change has to come from the industry, regulators and at a higher level the Government.”
It’s all very well Governments promoting biopharma as “the way forward for economic growth and product innovation,” he said, “but these industries also have to be sustainable from a waste and environmental perspective, a part of the equation that is all too often sidelined or forgotten.”
The plastic used in single-use bioreactors must be chemically inert (passing leachables and extractables testing), Class VI certified and free of any harmful additives in order to provide the optimum environment for cell cultivation, Global Product Manager at ATMI Eric Isberg told Biopharma-Reporter.com.
“Recycling is possible,” he said, though “modern single-use systems are a combination of plastics - [including polyethylene, polypropylene, ethylene vinyl alcohol, and nylon] - that often cannot be recycled without significant deconstruction.”
ATMI’s views were echoed by fellow bioreactor maker Sartorius, with Head of Product Management, Single Use Bioreactors, Dr. Thorsten Adams informing us of further issues hindering the recycling efforts.
“The use in the biopharmaceutical industry brings it in contact with materials which often prevent recycling,” he said. “For example, cultivation of genetically modified organisms in a single-use bioreactor renders the material unsuitable for further recycling.”
Therefore, for ‘disposable’ bioreactors to live up to their name the most viable option at present is incineration with energy cogeneration, according to Isberg. Furthermore, such combustion is endorsed by the US Environmental Protection Agency (EPA) who says it “is a widely-accepted waste treatment option with many benefits.”
Single-Use, Many Benefits?
Sartorius’ Adams told us there are several studies - the International Society for Pharmaceutical Engineering (ISPE) and Pall, for example - available in the public domain demonstrating the “positive impact and lower carbon footprint of using single-use technology” when compared to stainless steel approaches.
For both the manufacturing of and use of stainless steel systems a lot of energy is consumed, he said, and as for water usage, ATMI’s Isberg added “clean-in-place (CIP) and steam-in-place (SIP) for stainless steel tanks takes hundreds of thousands of litres of water annually,” with the extra water becoming “waste that requires processing and disposal.”
However, though Adams said “the net balance is positive for single use manufacturing,” Greenpeace remained concerned about the rush towards single-use systems.
There has been a history of using single-use plastic containers for tissue-culture and bio-based manufacturing due to sterility and cost issues, Santillo told us, “however the true cost (including environmental cost) of dealing with the waste then becomes an externality borne by others and not properly factored in to profit margins.
“In solving operational problems from a company's perspective, they may be contributing to growing problems with the ever increasing volume of plastic waste.”