Today, from Revio, we would like to share with some information on the regulatory framework regarding plasmids and Good Manufacturing Practices (GMPs) to help in the development of ATMPs that uses plasmids.
The following table illustrates where GMP requirements must be implemented while using plasmids as a starting material in gene therapy.
Therefore, tissues and cells used in an ex-vivo therapy don’t need to follow GMP principles (white). Also, manufacturing of starting plasmids should be applied GMP principles (light blue) and procedures such as the establishment of a bacterial or a cell bank or in-vitro transcription are expected to be within the scope of full GMP (dark blue), as well as active substance (such as mRNA, DNA, vectors or genetically modified cells) and finished product procedures.
What do we understand by “GMP principles”?
“A GMP certificate is not required for manufacturing and testing sites of starting materials for ATMPs. For certain starting materials of biological origin [according to the Directive 2001/83/EC] such as linear DNA used as template for ex vivo transcription into mRNA, plasmids to generate viral vectors and/or mRNA, and vectors) used to transfer genetic material for the manufacturing of ATMPs it is, however, mandatory that the principles of GMP are complied with.”
“The ATMP manufacturers have the responsibility to verify that appropriate GMP requirements are implemented.”
For further information about this, please check:
- Eudralex volume 4, Good Manufacturing Practice: Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products
- EMA Questions and answers on the principles of GMP for the manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of ATMPs
We hope you find this information useful and of interest. If you would like to discuss any of these points with the team at Revio, please get in touch here.