Not All cGMP Transfection Reagents Are Made Equal

An industry that operates according to cGMP regulations offers products whose quality, identity, purity, and strength have been tested and confirmed according to controlled manufacturing processes. The regulations that govern cGMP require a Quality driven approach to manufacturing (often quality by design or QbD) to minimize errors, supply chain disruption, contamination, and batch failures. The goal for cGMP is to protect patients from potentially unsafe or ineffective pharmaceutical or medical devices.

The cGMP manufacturing of transfection reagents has been growing exponentially as it has paralleled the growing demand for cGMP viral vector manufacturing for in vivo and ex-vivo gene therapy. Production of clinical grade viral vectors requires manufacturing under cGMP regulations to ensure patient safety. To do so, manufactures need to source qualified raw materials and to manage the supply chain.

Early developers needing viral vectors, need to keep patient safety in mind throughout the development of their processes. This starts with the quality and safety of the raw materials to be used and careful selection scrutinised manufacturing subcontractors. This approach will also improve risk mitigation strategies.