Pre-formulation & Formulation

The FUJIFILM Diosynth Biotechnologies laboratories are comprised of comprehensive and modern analytical and formulation capabilities and technical expertise to fully characterize and understand the product and process through extensive chemical and biophysical tools.

Pre-formulation studies are designed to learn about the protein’s susceptibility to a variety of relevant stresses, develop a baseline biophysical profile for the protein and determine potential degradation pathways of the product. During Pre-formulation we seek to understand the effect of process and handling steps on the stability of your molecule(s). For example:

  • Effects of Upstream Processing on the molecule intrinsic characteristics (Expression and Harvest)
  • Downstream processing conditions (Purification, Chemical Modifications)
    • Processing hold steps
    • Viral inactivation steps
    • UF/DF (buffer exchange/concentration)

Pre-Formulation is also essential for formulation development.

Formulation Development starts with Initial stress testing and biophysical screening of the molecule(s). Typical studies include:

  • Freeze/thaw
  • Agitation
  • Temperature
  • Excipients/Surfactants
  • Extremes of pH and ionic strength

Through this approach we help create an “insurance policy” for the successful and efficient manufacturing campaign of your product.

Our comprehensive Biophysical Characterization ToolBox includes:

  • Differential Scanning Calorimetry – MicroCalä VP-Capillary DSC Units: Used in the evaluation of conformational/thermal stability
  • Circular Dichroism – Jasco J810: Used in the evaluation of secondary & tertiary structures
  • MALS – Wyatt DAWN® HELEOS II MALS/Calypso GC-MALS/Optilab® T-rEX: Used to to determine molar mass, higher order structure
  • Fluorescence Spectroscopy – Perkin Elmer LS55: Used in the evaluation of tertiary structures
  • Dynamic Light Scattering & Zeta Potential – Malvern ZetaSizer Nano ZS: Used in determination of Zeta Potential, aggregates
  • Particulate Analysis (visible/subvisible) – HIAC 9703+, High Throughput Micro-Flow Imaging
  • Isothermal Chemical Denaturation (ICD) – AVIA Biosystems: Used to determine protein stability at room temperature or experimental temperature

Formulation development will develop a suitable liquid or lyophilized formulation for drug substance or drug product to ensure stability of your molecule during preclinical, clinical and commercial use.

Monoclonal antibodyOur Formulation services include:

  • Formulation development and optimization (liquid and lyophilized using SMART Freeze Dryer Technology) of Final Drug Product
  • High concentration Formulations
  • Standard approach to Monoclonal Antibody Formulation to reduce timelines and costs
  • Specialized Formulation Development for Product comparability (including biosimilar comparability)
  • Short and Long Term Storage Conditions (Freeze/Thaw Cycles)
  • Forced degradation programs (including identification of stability indicating assays and multi-lot comparison)
  • Design and execution of drug delivery studies including Device Compatibility and reconstitution