Ancillary Studies

At FUJIFILM Diosynth Biotechnologies we recognize the need for analytical studies that may be required to support the product characterization changes occurring during the development of your drug, and various important aspects such as forced degradation and clinical studies. We offer forced degradation studies that are anchored firmly on the product/process knowledge or intended usage, and are designed to understand the physicochemical and biophysical chemistry of your molecule and related impurities.

We offer custom characterization packages and forced degradation studies to support drug development.

Techniques include:

  • A broad range of spectroscopic, chromatographic (including UPLC™) and electrophoretic techniques
  • Biophysical characterization - CD, DSC, DLS, FT-IR, Micro-Flow Imaging™
  • Extended characterization - e.g., capillary electrophoresis, imaged IEF, glycosylation
  • Impurity characterization - e.g., SEC, IEX, Glycan peak collection and orthogonal identification

Typical stress regimes for forced degradation studies we offer:

  • Freezing & thawing
  • Thermal stress
  • Shear stress
  • Photo stress
  • Hydrolysis
  • Deamidation
  • Oxidation

FUJIFILM Diosynth Biotechnologies' analytical team ensures that the appropriate studies are designed to address the right questions posed by the regulators such as changes in scales, manufacturers, formulation, clinical dose ranging studies and transportation studies.

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