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Is self-sufficiency financially viable and ethically justifiable?--a commercial viewpoint
1Armour Pharmaceutical Company, Eastbourne, East Sussex, UK.
Summary
Achieving self-sufficiency in blood products requires high standards and significant investment. Public-private collaboration offers a financially viable alternative for ensuring plasma product safety and availability.
Area of Science:
- Biotechnology
- Public Health
- Regulatory Affairs
Background:
- Manufacturers of blood products must adhere to stringent plasma screening and manufacturing standards for viral safety and purity.
- Private sector companies possess extensive experience in regulatory compliance.
- Meeting these standards incurs substantial costs in plasma collection, research, manufacturing, and quality control.
Purpose of the Study:
- To evaluate the financial viability of total self-sufficiency in blood product manufacturing.
- To explore alternative models for meeting patient needs for plasma-derived products.
Main Methods:
- Analysis of the costs associated with plasma collection, research, manufacturing, and quality control.
- Assessment of the implications of total self-sufficiency versus public-private collaboration.
Main Results:
- Total self-sufficiency in blood products is financially unviable due to the loss of existing resources and high costs.
- The current definition of self-sufficiency is not financially sustainable.
Conclusions:
- A collaborative approach between public and private sectors is recommended to meet patient demand for plasma-derived products.
- Collaboration can ensure the purity and viral safety of blood products while managing costs effectively.