The Role Of GMP Guidelines In Regenerative Medicine

Good Manufacturing Practice Guidelines, or GMP guidelines for short, are standards that are put in place with the aim of regulating quality, safety and standards across industries including medical and food manufacturing. Here we look at the role of these GMP guidelines in the relatively new area of regenerative medicine.

Understanding regenerative medicine

Regenerative medicine therapies are different to more traditional forms of therapy in that they involve techniques such as tissue engineering and the creation of new types of medical products, such as genetically modified or even lab-grown cells. As such the products of regenerative medicines cannot be standardised in the same way that conventional medicines and pills can be, meaning that there is a requirement for different quality and safety standards. As a result GMP guidelines have had to evolve to allow proper regulation of this new branch of medicine.

A working example

An example of how GMP guidelines work in the area of regenerative medicine can be seen in researchers looking at the possibility of using mesenchymal stem cells (MSCs) to treat certain diseases. These MSCs are taken from the bone marrow of human donors. In order to ensure the quality of MSCs the following quality requirements are in place:

• The donor and donated bone marrow must be checked for infectious diseases.
• The recruitment of donors must be done in an ethical manner.
• All cells used in treatment must be traceable from the donor right through to the patient.
• Follow up observations of the donor and the patient must occur over a period of time.
• Manufacturer must maintain documentation relating to quality systems during the production process.

When you consider that these regulations only relate to the MSC side of the manufacturing process and that any raw materials and equipment must also conform to their own set of GMP guidelines; you realise just how stringent regulation of regenerative medicine is.

The rule makers

There are various regulatory bodies throughout the world that write GMP guidelines. In the USA the Food and Drug Administration (FDA) provides guidance, whereas Europe is covered by the European Medicines Agency (EMA). A large number of other countries across the world have their GMP guidelines provided by the World Health Organisation.

The aims of regulatory bodies

All regulatory bodies aim to achieve the same goals; balance potential risks against the benefits of a particular therapy, with the aim of ensuring that only safe products are released onto the relevant markets. Weighing up the pros and cons of each case can vary between the potential therapies. For example, it is possible that more risks will be taken with a medicine that could help cure a previously incurable condition.