CPhIonlineFebruary 09, 2022
Tag: COVID-19 , Biopharma , Vaccine
Various studies [i]and reports [ii]have noted the key role single-use technologies played in industry response to the pandemic. In March[iii], for example, the International Federation of Pharmaceutical Manufacturers & Associations (IFMPA), wrote that disposable systems were vital to efforts to add vaccine production capacity over the past two years.
Javier Lozano, Head of Process Engineering UK & Single-Use Specialist at engineering and facilities organisation PM Group also says single-use technologies have been critical to the fight against SARS-CoV-2 and its variants.
“The COVID-19 pandemic brought about a sudden need for the development and fabrication of new molecules and vaccines as quickly as possible. Single-use technologies’ key characteristics - flexibility and rapid deployment - mean that it has been the platform of choice for development of these new therapies.
“As a consequence, there has been a massive increase in demand, which has led to a significant strain in single-use manufacturing and dramatic increases in lead times,” Lozano says.
This dynamic was also highlighted by the IFPMA authors, who suggested the industry experienced “challenges in the supply of critical raw materials, testing reagents for batch release, single-use systems, and equipment required for vaccine manufacturing.”
However, as the pandemic recedes and technologies suppliers increase output, most supply chain difficulties are likely to be resolved, according to Lozano.
“We foresee that during 2022, the gap between manufacturing capacity and demand will be reduced with lead times slowly going back to pre-pandemic levels.
“However, it is important to highlight that single-use technologies within the biopharma industry are here to stay. Traditional reusable facilities [DT1] will remain an exception with the focus placed on the intensification of single-use technologies (SUT) use.”
During the early stages of the pandemic the focus was on speed, with vaccine developers under pressure to develop countermeasures. Governments worldwide were scrambling to develop strategies to slow the spread of COVID-19, and supply chain managers rushed to reconfigure sourcing and distribution networks.
As the pandemic has evolved, the focus has shifted and observers have started to look at the longer-term impact. One major focus in recent months has been concerns about the environmental impact of the sudden surge in vaccine production, with the increased use of single-use systems being raised as a potential issue.
But those worried about the sustainability of single-use technologies need to look beyond the terminology according to Lozano.
“Despite what it may seem by its own name, SUT are significantly more sustainable than traditional stainless steel (SS) facilities. Single-use facilities dramatically reduce the energy input required for manufacturing a new biopharma drug,” he says.
Single-use technologies are much less intensive in terms of water use, clean steam[DT2] and heating according to Lozano, who also points out that a single-use biopharmaceutical manufacturing facility can use 35-40% less energy than a traditional stainless-steel facility.
Reduced floor space is another factor. Lozano says “The sheer scale of single use facilities is dramatically smaller than traditional SS facilities. This greatly reduced footprint results in a significant reduction in construction materials (steel, concrete, etc.) and the resulting reduction in construction and material related emissions and environmental impacts.
“This has a knock on effect in the size of the area being serviced and reduction in the scale of HVAC air handling units needed, etc.”
However, while single-use technologies may not be the source of environmental concerns which the name suggests, they could still be made more sustainable.
Recyclability is one potential area for improvement according to Lozano, who says reducing current single-use systems to their component parts for potential reuse is still a significant challenge for the biopharmaceutical industry.
“In terms of recycling single-use components, it has proved to be very challenging. The main reason being that components are manufactured with multiple types of plastics. These are difficult to separate, which limits the possibilities for recycling altogether.
“The limited economic viability of the recycling process, has resulted in recycling efforts so far, being very localised.
“Another alternative to incineration and recycling is pyrolysis. This is where high temperatures with low levels of oxygen are used for the generation of fuel and landfill. Controlled landfill disposal should also be of consideration as an alternative to incineration,” he says.
“The key aspect that needs to be addressed is the end of life treatment of the plastics used. However, it is important to highlight that even with the current practice - where incineration is still the main method of treatment - CO2 emissions and energy consumption levels are lower for single-use technologies than for SS systems.”[DT3]
But ultimately rather than focusing on single-use technologies, biopharmaceutical industry sustainability efforts should concentrate on overall process efficiency Lozano says.
“There is still quite a lot that can be done within the biopharma industry to reduce our energy consumption. Use of the manufacturing space more efficiently, reducing the volumes of rooms with high environmental requirements, onsite generation of green energy, reduction on gas dependence for heating etc.
“All of these are initiatives that need to be developed and implemented across the industry to achieve the challenging net zero targets we have as an industry and society,” he says.
So, by increasing use of single-use technology, COVID-19 may ultimately end up making biopharmaceutical production more sustainable from an environmental standpoint.
The reconfiguration of supply chains prompted by the pandemic may end up having a similar impact according to Lozano, who says “A key development that we will see in the short term will be the result of a big push for standardisation from the end users. They have suffered significantly during the last two years’ due to supply chain issues.”
He explained that standardisation has the advantage of providing end-users multiple vendors to choose from, without impacting their process design.
“It also results in shorter lead times, due to the drawing approval stage being removed from the lead time, and the potential to have frequently used assemblies off the shelf.
“This also offers sustainability advantages at both the vendor and end-user site, due to the reduced requirement for warehousing space. Initiatives such as SDD are expected to see wide adoption, with much easier interchangeable designs and multiple, fully equivalent options available to the pharma companies to choose,” he says.
[i] https://www.researchgate.net/publication/353343222_Single-use_systems_bioreactors_in_the_biopharmaceutical_industry_and_its_use_in_SARS-CoV-2_vaccine%27s_candidates%27_production_A_review
[ii] https://www.businesswire.com/news/home/20210324005791/en/Global-Single-use-Bioprocessing-Market-2021-to-2026---High-Utilization-of-Single-Use-Bioprocessing-For-COVID-19-Vaccine-Production-Presents-Opportunities---ResearchAndMarkets.com
[iii] https://www.ifpma.org/wp-content/uploads/2021/05/Landscape_of_current_C19_supply_chain_manufacturing_capacity_embargo_9March2021.pdf
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