EMEA has issued guidance on plasma derived medicinal products. This guidance lays down the requirements of the collection of starting material, the manufacturing and the quality control of plasma derived medicinal products. Specific attention will be given to the viral safety of these products.
This is the fourth edition of the guidelines to be published, and include an update on the legal framework as well is an update on specific guidance.
Human plasma contains many proteins, extraction and purification of which are of great medicinal importance. Improvements in protein purification and molecular separation technology has made available a wide variety of products, with medicinal applications covering a large field, the therapeutic value of these products is unquestioned. However, the potential for viral transmission is well recognised, and because of the large number of donations which are pooled, a single contaminated batch of plasma drug product, with the contamination possibly originating from a single source donation, and transmit viral disease to a large number of recipients.
The prevention of such contamination is the main focus of these guidelines. They cover the whole process from the collection and testing of the starting material through quality-control manufacturing and preparation processes, a great deal of emphasis is put upon donor selection, traceability and post collection measures including look-back procedures. Process validation during manufacturing is also covered in the guidance, as well as quality control. These products have specific requirements for stability which are also covered.
This guidance is essential reading than anybody developing plasma derived therapeutic products.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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