Thermal characterization of the product

Product Description

Having information on the thermodynamic behaviour of our formula is critical to identify the critical product temperatures. At Comser, we have the following technology to characterize the product:
- Freeze Drying Microscope (FDM)
- Differential Scanning Calorimetry (DSC)

And with such, we are able to perform the thermodynamic characterization of the product and determination of critical parameters relevant to the development of a product specific lyophilization cycle such as glass transition temperature (Tg’), collapse temperature (Tc), eutectic temperature (Teu) and melting temperature (Tm).

Comser

  • ES
  • 2022
    On CPHI since
  • 1
    Certificates
  • 25 - 49
    Employees
Company types
Biopharmaceutical company
CMO/CDMO
Contract Research Organisation (CRO)
Contract Service
Other
Pharmaceutical company
Primary activities
Biopharmaceutical
Contract Manufacturer
Contract Research Organisation
Laboratory Services
Laboratory, Analytical, Biotechnology Equipment
Other
Technology

Comser

  • ES
  • 2022
    On CPHI since
  • 1
    Certificates
  • 25 - 49
    Employees
Company types
Biopharmaceutical company
CMO/CDMO
Contract Research Organisation (CRO)
Contract Service
Other
Pharmaceutical company
Primary activities
Biopharmaceutical
Contract Manufacturer
Contract Research Organisation
Laboratory Services
Laboratory, Analytical, Biotechnology Equipment
Other
Technology

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    The selection of the appropriate excipients is really important in the development of a freeze-dried product.
  • Lyophilization Process Development (Quality By Design approach)

    Product Lyophilization Process Development (Quality By Design approach)

    With the aim of obtaining a product that meets the critical quality attributes, but with the most optimized freeze-drying process.

    Our focus is the total control of the process. We develop freeze-drying processes in a previously defined design space: Quality By Design approach.

Comser resources (1)

  • Brochure Comser High Value Services

    Comser High Value Services Catalogues, broken down into three categories:
    - Overview of the whole Comser's value added services
    - Formulation & Lyophilization contract services
    - GMP Qualification & Validation of critical machinery and processes in aseptic environment