A Perspective on GMPs for Cellular Therapy Commercialization

November 22, 2018 Becky Hurt

Many current therapeutic treatments are not able to address the underlying cause of a disease, alter its course, or reverse damage that has already occurred. Cellular therapies offer the potential of the human body to heal and regenerate itself.

Cellular therapies can be classified by their therapeutic indication, by whether they contain cells taken from and administered to the same individual (autologous), or derived from a donor (allogeneic), and by their cell types. The regulatory classification of cellular therapies differentiates between minimally manipulated cells for homologous use, transplants or transfusions, and those more than minimally manipulated which are regulated as medicines.

The transitions from discovery, to research and development, to commercially manufactured products brings the challenge of the regulatory requirements for incorporating cGMP regulations into the collection, production, and delivery of these products. The cGMP regulations for this new frontier in regenerative medicine will be defined with a collaboration of clinicians, manufacturers and regulatory agencies. These developments will allow for cellular therapy treatments to become increasingly available to patients and will offer new treatments and the hope to cure many diseases.

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