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 (mAbs), recombinant proteins and viral vaccines. Our services are available to clients who manufacture at our location or elsewhere.

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Expert Bioanalytical Testing Solutions

Advanced Therapies has been performing bioanalytical testing for decades, helping to reduce pipeline risk and accelerate timelines.

State-of-the-Art Facility

High Quality

Commercial Experience

Track Record

Why Us?

We provide high quality bioanalytical testing services and custom analytical method development when needed.

Global Experience

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 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

mAbs/Recombinant Poteins

  • 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

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