Not All cGMP Transfection Reagents Are Made Equal: Pharmaceutical Versus Medical Device cGMP Manufacturing

cGMP grade transfection reagents should be produced and formulated following strict guidelines. Some suppliers manufacture transfection reagents according to medical devices cGMP standards which makes the reagents suitable for viral vector manufacturing in the United States but not suitable for direct administration into humans. Those are often labelled as “for research use only and further manufacturing. Not for use in humans or animals”. Others comply to pharmaceuticals cGMP guidelines, making the transfection reagent suitable for viral vector manufacturing as well as safe for administration in humans. Suppliers of transfection reagents produced under pharmaceuticals cGMP comply with pharmaceutical guidelines from start to finish, meeting more prescriptive product manufacturing and specifications. The use of pharmaceutical cGMP grade transfection reagents also ensures batch-to-batch consistency, traceability, and product specifications (identity, purity, potency, safety, and quality). Consistent with pharmaceutical cGMP regulations, a “full documentation” is generated with every single batch of transfection reagent to support the batch release by the Quality Assurance department. This documentation includes detailed batch production, information relating to starting material, equipment, training of personnel, process, cleaning, and of course quality controls related to the batch; ensuring batch compliance. Read more to get to know your transfection reagents: what cGMP guidelines are they compliant with?



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