Testing Platform | Service Platform

Home > Service Platform > Testing Platform

We provide customers with the development, verification and testing services of a full range of analysis methods for cell and gene therapy products to meet their needs from preclinical to commercial production

The quality management system of WuXi ATU is established based regulations from major countries, including:

FDA cGMP, EU GMP, China GMP, ICH Q8-10 EU GMP Part IV-ATMPs Appendix to China GMP – Draft for Comments for Cell Therapy Products

Service Content

Method development and validation, complying with ChP, USP, PhEur and relevant guidelines

Release testing of in-process control samples and final products

Sound quality standards, covering bacterial banks, cell banks, plasmid vectors, viral vectors, CAR-T products, etc.

One-stop service for stability study protocol, execution and report, meeting the requirements of customer application and also complying with ICH Q1A/B

Individual contract testing services, such as sterility testing, and mycoplasma testing, etc.
Service Characteristics

With decades of experience in this professional field, our team can provide a full range of analytical support for cGMP and non-cGMP production:
Analytical method development for special testing

Comprehensive and sufficient analytical method development

Comprehensive analytical method validation system

Precise and efficient test services

Comprehensive testing capability

Testing Platform

Quality system capability of WuXi ATU

Apply ICH Q8-Quality by design (QbD), providing customized science and risk based product development services, to enhance product quality and risk management throughout lifecycle.

Target Product Profile|Product Quality Attributes|Process Design Space|Process Assessment and Control