Application
Introduction:
After nearly 30 years of development, tools and technologies such as vectors, editing systems and immunology have greatly progressed, which provides significant theoretical and technical support for the safety and effectiveness of gene therapy. This progress has resulted in many breakthroughs in clinical gene therapy trials over the past ten years, and a new golden era of gene therapy is forthcoming.

Pracgen guarantees GMP production compliance in the whole process. All procedures have been developed, controlled, and validated. All production are strictly recorded in accordance with GMP requirements, and original data was kept to ensure traceability. Release tests are strictly conducted based on industry standards. Pracgen can provide modular services from DNA to IND to meet the diverse needs of gene therapy.

Procedure:

(1)Proof of concept

            Virus 

            Gene Editing

            Stable Cell Lines

(2)Process development optimization

(3)Manufacturing

            GMP grade Plasmid Manufacturing

            GMP grade Virus Manufacturing

            Cell Manufacturing

(4)Quality System

(5)IND Application

(6)Analysis & Testing


More Info:

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