Plasma fractionators play a critical role in the treatment of rare life-threatening conditions. Consistent, reliable performance is key to plasma fractionation, posing challenges that must be met in order to better serve patients around the globe: improving yield, maintaining process economics, and managing ever-increasing regulatory requirements. Choosing the right partner with deep understanding of these challenges is vital, offering fractionators a gateway to new solutions and resources that can enhance their full range of blood plasma products.
Application Note: Integration of Bioburden Reduction and Sterile Filtration in Human Plasma IgG Purification
Article: Process Steps for the Fractionation of Immunoglobulin (Ig) G Depleted of IgA, Isoagglutinins, and Devoid of in Vitro Thrombogenicity - Blood Transfusion Nov. 2021
Brochure: Leveraging the Advantages of Single-use in Plasma Processing
Brochure: Plasma Processing Capabilities
Webinar: Addressing Immunoglobulin (Ig) Purification Challenges with Chromatographic Technologies
Webinar: Implementing Single-use Technologies – A Plasma Case Study
Webinar: High Viscosity Ultrafiltration Formulation for Plasma IgG and mAbs
Webinar: Overcoming High Concentration Challenges in IgG Purification
Buffer Preparation for Plasma Processes: Process Efficiency
White Paper: Intensification of Human Plasma IgG Purification for Intravenous and Subcutaneous Administration
Webinar: Quality by Design Principles Applied to Sterilizing Filtration
Webinar: Design Reduces Contamination Risks in Final Filtration & Filling Processes
Webinar: Sizing, and Operation of Bioprocess Filtration Trains for Optimal Performance
Webinar: Your Filter. What’s Best for Your Process?
Webinar: Strategies to Address Bioburden Control in Downstream Processing
Webinar: Identifying Appropriate-quality Pharmaceutical Raw Materials in an Evolving Regulatory Environment
Webinar: Overcoming Quality and Regulatory Challenges of Implementing Single-use Pharmaceutical Manufacturing
Application Note: New Performance Assay for Eshmuno® P Resins
Article: Single-use Technology for Solvent/Detergent Virus Inactivation of Industrial Plasma Products
Article: What is Merck Doing About REACH Compliance?
Polyclonal immunoglobulin G (IgG) is the primary high-value product for all plasma manufacturers. Today, immunoglobulin is administered in higher concentration dosages; this requires formulations which are well-tolerated by the patient. Key parameters for tolerability include:
The clinical efficacy of IgG is determined by the process and the quality of manufacture. Key features include an intact molecule, physiological sub-class distribution, pH of administration, absence of pyrogens, and low toxic residue content. IgG is currently used to treat primary immunodeficiency (PID), neurological conditions, hematology, and other infectious diseases.
Albumin, often referred to as HSA (human serum albumen), is a stable protein with a molecular weight of 67 kD. It is sometimes added as a stabilizer for other plasma products, though its therapeutic use is as a fluid replacement treatment to expand blood volume in patients typically traumatized by burns or surgery. Albumin is manufactured in large quantities and is produced by all plasma manufacturers. Frequently, three to five batches per week may be manufactured in both low and high concentrations.
While raw plasma contains around 35–50 g of albumin per liter, 25–40% of that volume is lost during the actual fractionation process. This can lead fractionators to consider a chromatography method instead of Cohn fractionation, as chromatography has more favorable loss percentages of around 15–20%.
Improving purity while maintaining specific activity is important in production of Factor VIII (FVIII), an essential blood-clotting protein. Clinical requirements of administration to a patient include low immunogenicity and high purity, which translates to low isoagglutinins and accompanying protein count, no foreign proteins or DNA, and low amounts of chemical residues. The purification process is designed to achieve these requirements: