Gene Therapy Characterisation and Release Testing

Gene Therapy Characterisation and Release Testing
Product Description

Characterization and release testing of gene therapies: supporting CMC requirements for IND applications and commercial release through expert analysis and stability testing. We provide method development and validation to meet your milestone and regulatory requirement and help you to confirm identity and ensure the product safety, quality, purity, potency and strength of your gene therapy product. GMP analysis, GCP/GLP bioanalysis, ICH stability storage and testing, Method development and validation, General compendial testing, Viral vector characterisation, Viral vector identity, Virology assays, Aggregation analysis, Host cell and residual plasmid DNA, Cell-based assays / potency testing, QC release testing, Advanced delivery technology analytical support, Reagent QC analysis and residual reagent determination, Excipient concentration and QC, Determination of Residual proteins, DNA, RNA, cytokines, growth factors, serum, antibodies and solvents.

To learn more, visit our website:

www.intertek.com/pharmaceutical/biopharmaceuticals/gene-therapy-characterisation

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Intertek Analytical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain
View company profile
Categories
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Specifications
  • Supplied from
    United Kingdom
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Intertek Analytical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain
View company profile

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Intertek Analytical Services resources (2)

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    14 Sep 2022
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