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We turn complex biological testing needs into routine and reliable protocols. Whether the assays are compendial or client-specific, the protocols are developed and validated to ensure product quality, consistency, and compliance with GMP guidelines.
Let’s discuss your analytical needs
Our development team boasts decades of experience in bioanalytical testing, development and manufacturing. Crafting robust testing protocols for cell and gene products is our specialty.
We can develop tests for all types of complex biologics, vaccines, and cell and gene therapies.
Our team regularly assesses and integrates technologies that demonstrate trustworthy results.
We have decades of experience developing assays that can be validated and qualified.
Our team is well versed in the latest guidance delivered by the regulatory agencies and how to ensure compliance.
We turn complex analytical development challenges into routine and standard testing solutions.
WuXi Advanced Therapies has been developing new and custom analytical methods for cell therapies, vaccines, and other complex biologics for over 20 years with the vast majority validated for use in lot release and stability programs.
WuXi Advanced Therapies has been developing new and custom analytical methods for cell therapies, vaccines, and other complex biologics for over 20 years with the vast majority validated for use in lot release and stability programs.
Our team has a full repertoire of analytical methodology available to them for assay development including molecular biology, ELISA, microscopy, flow cytometry-based tests and more.
The analytical method development team has access to in-house regulatory expertise they can consult quickly to pinpoint issues that necessitate a change in direction before major investment is incurred – avoiding expensive re-work.
WuXi Advanced Therapies has a large on-site team that conducts routine testing and can be instrumental in testing and assessing the repeatability and feasibility of custom assays.
Our analytical development team leverages our state-of-the-art facilities and has access to our GMP bioanalytical testing, process development, manufacturing and regulatory support teams to develop robust analytics for your process.
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We leverage our vast experience in biosafety testing to develop analytical methods for viral, biologic, and vaccine production processes.
Vector specific tests
Residuals
Adventitious agents and toxins
Potency
Other custom assays
CAR expressions by flow cytometry
GOI-specific integrated copy number
General characteristics (cell count, viability, identity, impurities, etc.)
Safety (sterility, endotoxin, mycoplasma, replication-competent virus)
Potency
T-cell memory phenotype, activation, exhaustion
Adventitious agents (in Vitro and PCR-based assays)
Residual viral DNA
Microbial limits
Mycoplasma
General characteristics ( color, appearance, pH, osmolality, protein purity, titer, identity, potency)
Adventitious agents and toxins
Residuals
Adventitious agents and toxins
Residuals
General characteristics ( color, appearance, pH, osmolality, protein concentaration)