GMP facility

Presentation

InvivoGen Therapeutics operates its own GMP facility for the production of clinical lots of plasmid DNA for gene therapy trials.

InvivoGen Therapeutics' GMP facility is designed to:

Respect international Good Manufacturing Practices regulations for the production of DNA pharmaceutical products,

Allow large scale production (>1 g) of plasmid DNA and its complexation with cationic substances,

Allow aseptic filling ; the final DNA product is formulated under strict aseptic conditions in the form of a lyophilized injectable solution for phase I/II clinical trials.

With this GMP facility, InvivoGen Therapeutics is able to perform all the operations necessary to go from research projects to pharmaceutical products.

Facility Feature

Our state of the art GMP facility contains two areas built according to GMP standards to provide a class C (class 10,000) environment, for extraction and purification, and a class A (class 100) environment for aseptic filling, complexation and lyophilization.

Contract Services

InvivoGen Therapeutics provides contract GMP manufacturing and process development services.