Global Experience
WuXi Advanced Therapies has an exceptionally strong track record in bioanalytical testing. Since our inception, we’ve supported over 1700 customer submissions with biosafety testing.
Service
Contract Testing Services
As a cell and gene therapy CTDMO, we understand the critical role comprehensive testing plays in the success of your clinical or commercial product. We offer a complete suite of contract testing services including viral clearance, biosafety, release testing, cell banking and stability for cell and gene therapies, monoclonal antibodies and vaccines. Our services are available to clients who manufacture at our location or elsewhere.
Tell us about your testing needs
Expert Bioanalytical Testing Solutions
WuXi Advanced Therapies has been performing bioanalytical testing for decades, helping to reduce pipeline risk and accelerate timelines.
State-of-the-Art Facility
140,000 sq. ft. purpose build modern facility dedicated to testing on our Philadelphia, PA campus.
High Quality
We have received 100% acceptance on our test results with zero rejections from regulatory agencies.
Commercial Experience
Our team supports close to 30 commercial programs spanning cell and gene therapies, biologics, and vaccines.
Track Record
We have been conducting bioanalytical testing for decades and processed more than 1,700 customer submissions.
Why Us?
We provide high quality bioanalytical testing services and custom analytical method development when needed.
Global Experience
WuXi Advanced Therapies has an exceptionally strong track record in bioanalytical testing. Since our inception, we’ve supported over 1700 customer submissions with biosafety testing.
Depth of Expertise
Our team is best known for its significant expertise in assay development, biosafety testing, viral clearance, and clinical and commercial lot release testing.
Capacity
In 2021 we introduced a purpose-built testing facility at 400 Rouse Boulevard in Philadelphia which consists of 140,000 square feet of GMP compliant, flexible laboratory space. With this addition we gained capacity to meet the demand of our manufacturing clients, as well as companies who manufacture elsewhere, but conduct their testing with us.
Analytical Development
Our Analytical Development team has well over a decade of experience developing novel, custom methods to support the release of advanced therapeutics. Our team of experts can assess your therapeutic and develop phase-appropriate, product-specific assays to meet global regulatory expectations.
Release Testing
GMP compliant lot release tests ensure the safety of your product, while keeping timelines on track thanks to dedicated project managers and accelerated tech transfer and comparability studies.
Replication competency assays are key to assuring the safety of viral vectors, and WuXi Advanced Therapies has dedicated laboratory space and equipment for both the cell culture and endpoint techniques (PCR/ELISA) required for this type of assay
Reliable and Expert Partner
We are a true CTDMO, offering testing and also development and manufacturing, all at the same site. The fact that we offer development and manufacturing makes us a more intelligent testing partner as we truly understand the complexity of the entire product development, manufacturing and release process. Our track record speaks for itself.
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Lot Release Testing
Companies worldwide, from early-stage biotech start-up preparing for IND submission or manufacturing for clinical trails to big pharma with commercial products, use our testing services for lot release.
Lentiviral Vector Release
Titer (genome, infectivity, p24)
Presence of transgene/flow cytometry
Transgene sequence
Residual DNA (E1a, kanamycin, SV40 large T, VSV-G)
Residual host cell protein
General characteristics
Adventitious agents/toxins
Mycoplasma DNA by MycoSEQ
Absence of intact cells
AgentScreen (in R&D)
AAV Vector Release
Titer (genome, infectivity)
Potency assay (product specific)
Transgene sequence
General characteristics
Adventitious agents/toxins
Residual DNA (E1a, 18s kanamycin)
Residual Benzonase
Residual host cell protein
Residual leached ligand
Biologics
Adventitious agents/toxins
General characteristics
Residual DNA
Residual host cell protein
Residual Benzonase
Residual leached ligand
Vaccines
Titer (genome, infectivity)
Potency assay (product specific)
Transgene sequence
General characteristics
Adventitious agents/toxins
Residual DNA
Residual host cell protein
Residual Benzonase
Residual leached ligand