Analytical Development

Full analytical method transfer and development for a wide range of quantitative and qualitative test methods to demonstrate a well characterized product and process.

ACCURATE AND CONSISTENT

Assays to accurately guide your development and release

We routinely transfer, develop, qualify, and validate product specific, and compendial analytical methods (EP/USP) for customers to use as in-process controls or quality control batch release & stability assays.

Our analytical method development team offers a tailored service to each customers product and process, delivering suitable test methods to assess critical parameters and product safety through the phases of clinical development and commercial manufacture.

Analytical Development Services

  • In-house service in each US & EU facility
  • Transfer, development, or optimize existing assay
  • Phase-specific qualification/validation (ICH Q2(R1))
  • Assessment of specificity, linearity, LOD/LOQ, range, accuracy and precision
  • Support across various test methods (Safety, Quality, Identity, Potency, and Purity)
  • Ex: Potency & Titer (e.g. product-specific assays; genome, infectious, and transgene titer)
  • Ex: Identity & Purity (e.g. qPCR, RT-PCR, dd-PCR, western blot, SDS-PAGE, restriction-enzyme mapping, MADLS, etc.)
  • Ex: Residuals (e.g. HC-Protein by ELISA, HC/Plasmid-DNA by qPCR, BSA, Benzonase, Chromatography leached ligand by ELISA, etc. )

Analytical Development experts

We’re the ideal CDMO for your Analytical Development project

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