Healthcare Through Plasma Fractionation

Blood plasma, an invaluable component of human blood, stands as a cornerstone in the realm of modern healthcare and therapeutic interventions. In the plasma fractionation industry, plasma donation (which acts as the starting point for plasma fractionation), meticulous screening protocols, and judicious plasma fractionation processes are collectively utilized to develop life-saving plasma-derived therapies. These possibilities include a list of plasma-derived products such as albumins, coagulation factors and immunoglobulins. These plasma-derived therapeutic products addresses a wide range of disorders, such as oncological disorders, hematological disorders, hepatic disorders, neurological disorders, pulmonary disorders, and immunological disorders, with precision and efficacy.

Historical Evolution of Plasma Fractionation

The major motivation for the use of plasma as a medicinal agent was driven by the Second World War. During 1940s, Dr. Edwin Cohn and colleagues first manufactured albumin at commercial scale through Cohn fractionation of plasma to treat burn victims. Followed by this discovery, Cohn designed and modified Cohn’s method so as to include sequential harvesting to extract a number of protein fractionates as potential therapeutic products. These protein fractionates included fibrinogen and immunoglobulin products. In Cohn’s plasma fractionation method, five fractionation steps, fraction I to fraction V, results in five protein fractions. The main components are fibrinogen, immunoglobulins, alpha-1 antitrypsin, transferrin and albumin, obtained respectively in fraction I, fraction II, fraction III, fraction IV and fraction V. The fraction I to V were prepared by adjusting parameters, such as concentration of ethanol, concentration of protein, pH and temperature. Over the years, the Cohn process was modified and advanced by implementation of new technologies. These advancements have led to increased purity and a range of other plasma-derived products. The list of plasma-derived products includes albumins, coagulation factors, immunoglobulins, and protease inhibitors. Despite the development that took place recently, the backbone of modern plasma fractionation technique is mainly based on cold ethanol fractionation of plasma.

It is worth noting that the complex composition of blood plasma was first identified by the Nobel Prize laureate Arne Tiselius and Theodor Svedberg, which resulted in the identification of several plasma proteins with therapeutic value. Amongst all the plasma fractions, four have gained significant importance on a commercial scale driven by substantial demand from patients suffering from rare and chronic diseases. These proteins include albumin, immunoglobulin G, coagulation factor VIII, and coagulation factor IX.

From Blood Plasma to Medicinal Marvels: The Art of Plasma Fractionation

Plasma fractionation is a sophisticated bioprocessing methodology that refines and segregates plasma constituents into distinct protein fractions. These fractionates that are commonly known as plasma-derived medicinal products or therapies, undergo a series of steps including precipitation, chromatography, purification, and virus-inactivation. It is worth noting that the fractionation process can be seamlessly scaled from research to commercial production, reflecting the advanced development of the intricate procedures within the blood plasma fractionation industry over the years.

Plasma typically encompasses modifications to the physical and chemical attributes of blood plasma, inducing shift in solubility that lead to precipitation of specific target proteins.

Plasm Fractionation Market- This image shows the steps involved in plasma fractionation process

This figure presents the steps involved in plasma fractionation process.

This intricate process yields over 30 distinct list of plasma-derived products, instrumental in addressing diverse medical conditions. The following lists some of the plasma-derived therapies:

  • Albumins
  • Immunoglobulins
  • Coagulation Factors
  • Anti-coagulation Factors
  • Protease Inhibitors
  • Other Protein Fractionates

Imperative Safety and Quality in Plasma Fractionation

Unlike traditional pharmaceuticals and biopharmaceuticals, plasma-derived therapies cannot be developed in a laboratory and require unique starting material, that is human plasma. Owing to the raw material, there are several obligations for manufacturing plasma therapies, which are focused on safety profile. Various safety measures are adopted from the very first step, that is plasma donation, and in steps involved in the plasma fractionation (plasma manufacturing) process. It is worth noting that according to the USFDA and good manufacturing practices (GMP) regulations, the donated blood and plasma need to go through a series of serological tests prior plasma fractionation, such as Nucleic Acid Technology (NAT) in combination with other immunoassays, to detect Hepatitis A (HAV), Hepatitis B (HBV), hepatitis B surface antigen (HBsAg), Hepatitis C (HCV), Hepatitis E (HEV) and antibodies against human immunodeficiency virus (HIV). , These safety procedures are employed to develop safe plasma-derived therapeutic products, without risks for transmittable diseases via blood.

Evolving Dynamics of Plasma Fractionation Market

The landscape of the plasma fractionation industry has undergone significant shifts, driven by the far-reaching effects of the COVID-19 pandemic. One notable consequence in the plasma fraction market has been a considerable reduction in plasma donations, leading to pronounced supply constraints. Despite this, the global demand for plasma-derived therapies continues to rise, creating a complex interplay of challenges and opportunities within the plasma fractionation market. Further, the pandemic has renewed the interest of plasma fractionation companies in convalescent plasma, particularly as a front-line defense in emerging infectious diseases. This renewed focus underscores the significance of plasma manufacturing and plasma fractionation mitigating health crises.

In response to the escalating demand for plasma fractionation, several strategic initiatives have been set in motion by the plasma fractionator. In 2021, the UK made one such pivotal move by rescinding the longstanding prohibition on utilizing domestic blood plasma for clinical purposes. This prohibition, originally enacted over twenty years ago as a precautionary response to the threat of mad cow disease (bovine spongiform encephalopathy). The result has been a notable surge in the UK’s yearly plasma collection volume, thereby fortifying the capacity for localized manufacturing of plasma-derived products to meet the needs of patients within the nation.

It is worth highlighting that numerous stakeholders are actively exploring innovative plasma fractionation technologies. These technologies aim to enhance the efficiency of plasma fractionator, marking a shift in the plasma fractionation market. Plasma fractionator are adopting various novel approaches such as continuous manufacturing and flammable material-free fractionation to develop highly efficacious plasma-derived therapies. These advancements hold the potential to reshape the plasma manufacturing processes adopted by various plasma fractionation companies, indicating a dynamic and forward-looking approach to meet the escalating demand for list of plasma-derived products.

Rising Demand for Contract Services

Leveraging contract fractionation is an efficient approach to supply plasma therapies, in regions where a local plasma fractionation entity is absent. This approach offers a cost-effective alternative for plasma fractionation companies to establish and operate a full-fledged fractionation plant. To ensure uncompromised quality, regulatory oversight becomes imperative for both plasma suppliers and contracted fractionators engaged with plasma therapy providers. The service providers are further examined to meet the below mentioned criteria:

Plasma Fractionation Market- This image shows the Good Manufacturing Practice.

This figure presents the requirements for being a contract plasma fractionator.

Bottom Line

Keeping every trend in mind, Roots Analysis has provided complete information on market trends in global single-use bioreactors domain in its report titled, Plasma Fractionation Market, 2023-2035. The research report has some of the very recent and precise activities listed for the clients to help them make better decisions. Further, it presents current and future opportunity trends associated with the global plasma fractionation market, for the time period between 2023 and 2035.

For detailed insights about this domain, check out our report on Plasma Fractionation Market, 2023-2035