Skip to Main content Skip to Navigation
Journal articles

Small-scale GMP production of plasmid DNA using a simplified and fully disposable production method

Abstract : In the past years, the demand for small batches of clinical grade plasmid DNA has been growing. For that purpose, we designed and qualified a scaled-down Good Manufacturing Practices (GMP) production method, able to produce small batches (1-4mg) of plasmid. The developed method does not require any complex production equipment and utilizes only disposable production materials, which makes it easy to implement and simplifies line-clearance. We have successfully used this method to produce several small batches of two different plasmids. The produced plasmids, both formulated in an Electroporation Buffer, are mixed and filled into small, single-use, aliquots. Quality control confirmed the robustness of the developed method and a stability study showed that the final formulation is stable for at least two years. The final patient formulation will be subsequently used in a phase I/II clinical trial in which retina cells of patients with Age Related Macular Degeneration, are transfected. The presented production method can be generically used for other plasmid constructs and final formulation designs.
Document type :
Journal articles
Complete list of metadata
Contributor : Colette ORANGE Connect in order to contact the contributor
Submitted on : Friday, September 10, 2021 - 10:10:43 AM
Last modification on : Sunday, June 26, 2022 - 3:13:04 AM
Long-term archiving on: : Saturday, December 11, 2021 - 6:33:34 PM


Publisher files allowed on an open archive



Noor Am Bakker, Renate de Boer, Corinne Marie, Daniel Scherman, John B a G Haanen, et al.. Small-scale GMP production of plasmid DNA using a simplified and fully disposable production method. Journal of Biotechnology, Elsevier, 2019, 306S, pp.1000007. ⟨10.1016/j.btecx.2019.100007⟩. ⟨hal-03295934⟩



Record views


Files downloads