Comparability Studies for Biopharmaceuticals

Comparability Studies for Biopharmaceuticals
Product Description

We design bespoke analytical programmes that ensure that the relevant quality attributes for your drug substance or product are evaluated to support your manufacturing process changes. We select analytics referenced by the ICH Q6B to examine the product's structural features (primary, secondary and HOS and assessment of PTM, glycosylation), physicochemical properties, biological activity /potency and immunogenicity to demonstrate that modifications did not occur which may adversely impact drug safety and efficacy. We assess purity/impurity profiles and conduct comparability to GLP or GMP. Our laboratories are equipped with a broad technology base including strengths in MS (Orbitrap and QToF and high-resolution, accurate-mass (HRAM). We select from different analytical techniques to deliver comparability studies for proteins, antibodies, ADCs, biosimilars, oligos and other biologic products.

To learn more, visit our website:
www.intertek.com/pharmaceutical/biopharmaceuticals/comparability

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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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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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