Lyophilization Process Development (Quality By Design approach)

Lyophilization Process Development (Quality By Design approach)
Product Description

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

  • 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 Research Organisation
Laboratory Services
Laboratory, Analytical, Biotechnology Equipment
Other
Technology
Specifications

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 Research Organisation
Laboratory Services
Laboratory, Analytical, Biotechnology Equipment
Other
Technology

More Products from COMSER (4)

  • Formulation of lyophilized products

    Product Formulation of lyophilized products

    A correct formulation means greater stability of the active ingredient and provides protection against the stress suffered during the lyophilization process itself.

    The selection of the appropriate excipients is really important in the development of a freeze-dried product.
  • Thermal characterization of the product

    Product Thermal characterization of the product

    Having information on the thermodynamic behavior 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)

  • Scale-Up and Transfer of lyophilization processes

    Product Scale-Up and Transfer of lyophilization processes

    From the laboratory to the industry. 

    The key to a correct Scale-Up and Transfer of lyophilization processes is the knowledge of the developed product, as well as the control of the process and the capabilities of the final equipment.
  • Theoretical-practical WORKSHOP on lyophilization (3 full days)

    Product Theoretical-practical WORKSHOP on lyophilization (3 full days)

    The format of this course is hybrid, you can attend in person or online.

    Next edition: November 2022 (in Spanish); May 2023 (in English)