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Belrose

Analytical Development Services

Belrose draws on its extensive analytical capabilities to help Collaboration Partners accelerate the development of their proprietary therapeutic candidates.
 

Examples of Analytical Services

Belrose delivers a wide range of analytical services for conjugated therapeutics, including cGMP product release testing and ICH GMP product stability. Specific Analytical Services include:

  • Assay and impurity analyses
    • Transferring in validated assays
    • Modifying existing assays
  • HPLC Method Development
    • Reverse Phase HPLC
    • Normal Phase HPLC
    • Gel Filtration/Size Exclusion Chromatography
  • UV, DAD, RI & ELSD Detection Systems
  • HPLC Method Validation
  • Analysis of PEGylated molecules, e.g.,
    • SDS-PAGE
    • RPHPLC
    • PEG#
  • Gas Chromatography
  • Mass Spectrometry
  • Other Analytical Services

 

Examples of Working Arrangements

Belrose has experience providing analytical support to Collaboration Partners, including:

  • “Full Outsource” through tech transfer to the facility manufacturing the registration batches
  • “Early Stage” analytical to support Proof of Concept testing with early transfer to Collaboration Partner or selected vendor
  • Anything in between these two extremes