The BIO International Convention is currently ongoing and one of the sessions featured Justin Carbungco, associate director of small scale manufacturing at Samsung Biologics.
During his presentation, entitled ‘Good debate: Single-use or stainless steel?’, Carbungco compared the current utilization of single-use bioreactors against stainless steel systems, indicating where each system was finding its particular niche in the bioprocess.
He noted that this can be broadly broken down into the predominance of single-use systems in pre-commercial production, while stainless steel systems tend to takeover at the commercial scale.
The reasons for this are the scale at which both operate most conveniently and the associated cost, which sees 85% of pre-commercial usage being single-use.
For instance, Carbungco outlined that the 1,000L to 2,000L scale for single-use bioreactors seems to be their ‘sweet point’, after Samsung Biologics received feedback from customers that anything beyond is ‘unwieldy’ and ‘hard to install’.
He did note that this could change in the future: “However, as innovations come up and the technology is improved upon and refined, there is potential that single-use will be further utilized [at large-scale].”
One additional factor that swings the scale towards stainless steel at the commercial stage is the cost of operation.
Carbungco weighed the two systems in this manner: single-use system have a lower implementation cost but operation cost is higher, whilst the opposite is true for stainless steel systems.
As well as this, single-use is primarily confined to mammalian cells, whereas stainless steel can be used for both mammalian and microbial.
Booming single-use market
The current limits of single-use systems is not enough to put a dampener on the potential for this segment of the market.
Carbungco cited statistics predicting the area to grow at a compound annual growth rate (CAGR) of 12.8% towards 2027, as well as the area seeing year-on-year growth rate of 10.85%, as of 2020.
The sector was worth $12.6bn (€11.07bn), as of 2019, and is predicted to be worth $33.1bn (€29bn) by 2027.
Supply chain management
However, there has been one factor emerging recently that has caused problems for the use of single-use systems: the COVID-19 pandemic.
Addressing the challenges faced across the industry, Carbungco stated, “The entire supply chain of the industry was impacted due to [the pandemic]. We had conditions like social distancing where manufacturers and vendors had to work with the government’s recommendations. This may have required people to reduce work hours or reduce manpower in certain areas.”
The specific problem facing single-use systems during the ongoing crisis is that they are comparatively heavy in the use of consumable material.
This became an issue when the industry witnessed a ‘hoarding mentality’, Cabungco said.
He explained, “We have seen a ‘hoarding mentality’. This has compounded the higher demand placed on the vendors. We have seen people ordering a lot more consumables in order to make sure their production and manufacturing schedules are not impacted.”