In 2021, the UK lifted the ban on domestic blood plasma for clinical use—brought in two decades ago in response to mad cow disease (BSE, or bovine spongiform encephalopathy). This policy change boosted the UK’s annual plasma collection volume, supporting greater plasma-derived product manufacturing potential for local patient needs. Germany, Austria, Hungary, and the Czech Republic account for 40% of plasma collection for fractionation in the rest of Europe. There is an on-going revision to the EU Blood, Tissues, and Cells (BTC) legislation that many hope will lead to other countries ramping up plasma collection and fractionation.
While policy change may open the door, developing a domestic supply of plasma and manufacturing capacity for plasma products can’t be done with the flip of a switch. Here are some of the hurdles to clear before we can sufficiently fight the plasma shortage and attain regionally reliable inventories of plasma:
Plasma collection for fractionation is logistically and technically complex
Any country wanting to collect its own plasma needs a national regulatory body capable of overseeing the regulatory and safety compliance of its collection centers and logistics providers in keeping with the strict international guidelines and regulations for plasma for fractionation. Coupled with the significant financial investment needed to build and staff collection centers, this becomes a substantial burden, particularly for low- and middle-income countries.
Plasma storage and transport rely on cold chain management
Maintaining low temperatures during plasma fractionation is essential for plasma-derived products’ yield, safety, and effectiveness. From the time plasma is first collected and frozen, it must be fully traceable and monitored for any temperature variations. This adds complexity and cost to the overall plasma collection and manufacturing infrastructure.
Plasma fractionation facilities are complex and expensive to design and build
The large volume of a traditional batch process inherently leads to large, complex, and expensive stainless steel equipment and piping systems. Common fractionation methods use large quantities of flammable liquids, carrying unique building code requirements, and add to construction costs. While manufacturers can minimize some of these challenges with smart approaches in design and construction, a domestic fractionation facility will still come with a significant capital cost.
Plasma fractionation facilities require a large, qualified labor force
Safe and efficient operations of these large-scale facilities, and their production of safe for consumption products, requires a large, experienced team of well-trained staff. It also requires a robust framework and team dedicated to quality assurance and control.
The capital expenditure associated with designing and building a fractionation facility is arguably the most difficult of these challenges to overcome. Ultimately, this is driving the industry to take a closer look at novel plasma fractionation methods and facility design.