Service

Analytical Development

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.

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WuXi Advanced Therapies AMD

Complex Method Development

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.

Diverse Experience

Proven Technologies

Track Record

Regulatory Support

Why Us?

We turn complex analytical development challenges into routine and standard testing solutions.

Decades of Experience

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.

 

Comprehensive Capabilities

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.

Regulatory Support

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.

 

Routine Testing on Site

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.

Collective Testing and Analytical Experience

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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Analytical Development Capabilities

We leverage our vast experience in biosafety testing to develop analytical methods for viral, biologic, and vaccine production processes.

 

Viral

  • Vector specific tests
  • Residuals
  • Adventitious agents and toxins
  • Potency
  • Other custom assays

CAR-T

  • 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

Vaccines

  • Microbial limits
  • Mycoplasma
  • General characteristics ( color, appearance, pH, osmolality, protein purity, titer, identity, potency)
  • Adventitious agents and toxins
  • Residuals

Biologics

  • Adventitious agents and toxins
  • Residuals
  • General characteristics ( color, appearance, pH, osmolality, protein concentaration)

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