Viral Vectors | Production Platform

An international, one-stop cell and gene therapy viral vector R&D and industrialization service platform

Viral vectors, as a safe and efficient means of gene delivery, have been widely used in cell and gene and cell therapy. At present, the most commonly used viral vectors include non-replicating productive viral vectors (lentiviral vector-LVV, adeno-associated viral vector-AAV, etc.) and replicating productive viral vectors (oncolytic herpes simplex virus-oHSV, adenoviral vector-AdV, etc.).
WuXi ATU established a proven production technology platform for viral vectors, as well as GMP viral vector production lines, which are in compliance with international regulatory requirements. As a global leader, WuXi ATU viral vectors for cell and gene therapy platforms, can provide global pharmaceutical and biotechnology companies with all-round and highly flexible customized one-stop CTDMO (Contract Testing, Development and Manufacturing Organization) services from viral vector construction, cell bank establishment, process development, scale up, GMP manufacturing to method development, and quality testing and release.

Viral vector

The CTDMO platform for lentiviruses and adeno-associated virus vectors of WuXi ATU consists of five open production technology platforms that can efficiently provide high-quality services with price advantage to customers worldwide. Based on the QbD concept and cGMP requirements of the United States, European Union and China, WuXi ATU has designed and built four independent viral vector GMP manufacturing lines (2,100 m2), which have passed the audit by a number of pharmaceutical partners with achievement of successful cooperation.

Cell Platform for Viral Vector Production

293T/293 cells and insect cells (suspended and adherent cell types) with clear sources and clear authorization are used on the platform, which are stable and uniform. A three-level GMP cell bank system has been established for all cell lines, and they are tested and released according to the requirements of pharmacopoeias.

It can provide customers with high-quality cell bank construction services in line with the GMP requirements, such as three-level cell bank construction, cell passage stability study, etc., and provide complete relevant experimental records.

Provide customers with high-quality cell products for viral vector production to help customers accelerate their product development.

Production Technology Platform of Lentivirus and Adeno-Associated Virus Vector Adherent Process

Depend on a cell factory with a production scale of 28~65L, and the fully closed and disposable viral vector adherent production process to minimize contamination and cross contamination.

Typical Manufacturing Flow for Adherence Process

Production Technology Platform of Lentivirus and Adeno-Associated Virus Vector Suspension Process

Depend on a disposable bioreactor with a production scale of 50~200L and the fully enclosed, disposable viral vector suspension process to minimize contamination and cross-contamination.

Typical Production Flow of Suspension Process

Based on the QbD concept and cGMP requirements of the United States, European Union and China, WuXi ATU has designed and built four independent viral vector GMP production lines（2,100ｍ^２）,which have passed the cooperative audit by numbers of pharmaceutical partners with achievement of successful cooperation.

Productivity

Equipped with a BSL-2 Grade GMP Viral Vector Production Workshop, and a Grade A Sterile Isolator Filling System

Advanced fully enclosed disposable aseptic manufacturing process with separate personnel flow and one-way flow design to minimize contamination and cross-contamination

8 independent production operation units of modular design ensure flexible production scheduling with a production capacity up to 120 batches/year

A complete quality control system enables strict monitoring and release of the production process, with a complete and traceable CMC original record

A professional technical production and project management team with rich experience in large-scale production, to achieve full-process tracking management by special personnel

Meet the requirements of cGMP production management system in China, the United States and Europe, and have provided CTDMO services to customers in many countries around the world

For more information about the [Viral Vector] CTDMO platform 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