LyoFlow

LyoFlow
Product Description

LyoFlow® is a patented Process Analytical Technology (PAT) developed by COMSER that enables real-time, non-invasive measurement of vapor mass flow rate during the primary drying phase of a lyophilization process. By providing direct insight into the actual sublimation rate, LyoFlow helps pharmaceutical companies better understand product and equipment limitations, accelerate process development under a Quality by Design (QbD) approach, define and monitor the Design Space, optimize cycle parameters, determine the end point of primary drying, and facilitate scale-up and technology transfer activities. 

The technology can be retrofitted to both pilot- and production-scale freeze dryers, supporting the development of more robust, efficient, and scientifically driven lyophilization processes.

Comser

  • Country/Region:
    Spain
  • Founded:
    2013
  • On CPHI since:
    2022
  • Certificates:
    2
  • Employees:
    50 - 99
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

  • Country/Region:
    Spain
  • Founded:
    2013
  • On CPHI since:
    2022
  • Certificates:
    2
  • Employees:
    50 - 99
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

More Products from Comser (7)

  • 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)Kv Determination (LyoFlow)

  • 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.
  • 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.
  • Trainings

    Product Trainings

    We do offer specialized trainings in Aseptic Environment and Lyophilization process. The format of this course is hybrid, you can attend in person or online.


  • Aseptic Services

    Product Aseptic Services

    We provide a wide range of GMP Consultancy in aseptic process, such as: GMP equipment qualification, manufacturing process validation, supplier audits, critical tests (Smoke test, integrity test) and expert advise. 
  • Freeze-drying Contract Manufacturing

    Product Freeze-drying Contract Manufacturing

    Starting in 2027, COMSER will offer aseptic GMP contract manufacturing services to support the clinical advancement of new drug products. Our facilities are designed to supply high-quality material for small GMP freeze-drying batches, leveraging our proprietary LyoFlow technology to ensure process robustne...
  • 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.

Comser resources (2)

  • 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
  • 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