MHRAs cavalier attitude toward patient safety carries on apace
Anything goes for gene therapies, apparently, and your government doesn't care!
MHRA updates its definition of reconstitution activities in 2022
In UK, MHRA has changed Regulations to facilitate mRNA technology (gene therapy), by changing its definition of reconstitution.
In the 2022 update to MHRAs Regulatory Bible, the Orange Guide, changes have been introduced to the rules that apply to Advanced Therapy Medicinal Products only (ATMPs – this includes gene therapies).
Section 16.12 of the 2022 Guide states:
“The following are examples of reconstitution activities relevant for ATMPs. It is stressed that these examples cannot be extrapolated to medicinal products other than ATMPs.
Thawing, washing, buffer exchange, centrifugation steps ready to remove preservation solution (eg dimethyl sulphoxide [DMSO]), removal of process related impurities (residual amount of preservation solution, dead cells), including filtering;
(Re)suspension, dissolution, or dilution with solvent/buffer, dispersion;
Mixing the product with patients own cells, with an adjuvant and/or with other s…