Plasmid | Production Platform

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Complete Process Service from Plasmid Strain Bank Establishment to GMP Manufacturing Supports to Accelerate the Progress of Customer Projects

WuXi ATU plasmid production platform provides end to end integrated customization services from plasmid strain construction, clone screening, strain bank construction, process development, non-clinical research grade plasmid production to clinical GMP grade plasmid production according to customer needs at different stages. Based on the QbD design concept, the platform can quickly provide customers with high-quality, competitive customized plasmid products for laboratory production and clinical use, and accelerate customer product development and clinical supply. It has successfully provided services for multiple pharmaceutical partners around the world.

Whole Process Services from the Plasmid Strain Bank Establishment to GMP Manufacturing

There are independent plasmid development laboratories, GMP bank production lines of plasmid strains and GMP plasmid production lines in WuXi ATU. With a flexible production scale and a fermentation tank scale of 5L~200L, it provides plasmid production services from 50mg to 10g to meet different customer needs.

Establishment of Plasmid Strain Bank and Process Development Process

WuXi ATU has developed and established a set of proven procedures and documents for plasmid construction, clone screening, strain bank construction and plasmid production process development based on plasmid host strains with clear sources. Based on the target gene DNA provided by the customer, WuXi ATU can efficiently and economically provide customers with GMP plasmid strain bank construction and high expression plasmid production process establishment services depending on the platform technology.

Plasmid Strain Bank

Process Development Procedure of Plasmid Strain Bank

Plasmid Manufacturing Process for Non-Clinical Studies

In a short turnaround time, WuXi ATU can provide customers with high-quality, competitively priced customized plasmid products made in the laboratory, helping customers to efficiently carry out non-clinical studies. It can also provide customers with commercial products of plasmid packaged by auxiliary packaging of viral vectors for non-clinical studies, accelerating customer product development.

GMP Plasmid Manufacturing Process

Based on the concept of QbD, the GMP manufacturing platform and factory building of WuXi ATU can provide customers with high-quality and high-purity plasmid products of GMP grade; at the same time, in cooperation with OXGENETM, it can provide customers with commercial products of plasmid packaged by auxiliary packaging of GMP grade viral vectors, accelerate the clinical supply of plasmid products and help customers to carry out clinical studies smoothly.

Service Characteristics

The design based on the QbD concept and a fully enclosed system, separation of human flow and logistics, disposable equipment and processes help effectively reduce contamination and cross-contamination

An independent plasmid development laboratory, a flexible production scale, and culture with a shaker flask or fermentor meet different customer needs

Independent GMP manufacturing workshop, high-density fermentation process, and control of the whole production process meet the GMP manufacturing requirements of China, the United States and the European Union

On-time delivery contributes to a significant price competitive advantage

A professional, efficient and experienced team enables full process service

The well-developed quality management system helps to successfully achieve the audit and cooperation of many pharmaceutical partners worldwide

For more information about [Plasmid Production] CTDMO services, please contact

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无锡生基医药科技有限公司 WuXi ATU Co., Ltd.

Tel:+86（510）8858 3666

Email: info_atu@wuxiapptec.com

Address: Floor D7-5, Huishan Life Science Industrial Park, No. 1719 Huishan Avenue,
Huishan Economic Development Zone, Wuxi, Jiangsu Province

WuXi Advanced Therapies