Lonza DPS offers a wide range of special services both for parenteral biologics and small molecule drug products. These include:

  • Extractables and leachables
  • Subvisible and submicron particle characterization
  • Packaging and device characterization
  • Higher order structure and comparability
  • Drug/device combination product functionality testing

  • Extractables and Leachables

    Our DPS' forensic chemistry group has extensive experience designing, performing and reporting extractables and leachables studies for container closure systems as well as process and manufacturing equipment. Our experts have exceptional industry experience and have designed a risk-based strategy for extractables and leachables assessments and can provide in-depth guidance to design and execute the appropriate study tailored to the product and sample types required for testing.
  • The state-of-the-art particle lab is able to characterize subvisible and submicron particles using complementary methods covering the entire nano and micro-particle ranges, such as: dynamic light scattering (DLS), static light scattering (SLS), asymmetric flow field flow fractionation (AF4), nanoparticle tracking analysis (NTA), resonant mass measurement (RMM), Coulter counter (CC), microflow imaging (MFI), light obscuration (LO), scanning electron microscopy (SEM), and visual inspection.

    The particle lab can help design an adequate subvisible and submicron particle-control strategy including specification setting to meet current health authority requirements and beyond.

    Together with the particle lab, the forensic chemistry group offers fast-track particle contamination root cause investigations in drug product processing and manufacturing and provides best inputs into regulatory filings and questions.

  • Primary packaging is in direct contact with the formulated biologic throughout its shelflife, and can thus have significant impact on its stability and performance. The selection of the appropriate primary packaging (e.g. type of glass its lamination, material, lamination and dimensions of the stopper) are important selection parameters. Our glass delamination assessments, fogging studies and characterization by computer tomography can generate valuable insights, such as on potential stability liabilities but also on potential container issues that may occur during processing and manufacturing.
  • During development, various aspects of a drug product may undergo some level of change, either as planned upfront based on the chosen product development strategy, or as a result of specific development challenges. These changes include:

    • Qualitative or quantitative changes in the formulation (composition)
    • Protein concentration
    • Fill volume 
    • Delivered volume
    • Primary packaging and/or device (e.g., change from vial to syringe)
    • Route of administration (e.g., change from IV to SC injection)
    • Drug product manufacturing process (unit operations and/or parameters

    Our DPS can support the customized assessment of any parenteral drug product change, assessing risks and potential differences, and supports in evaluating these differences (“comparability assessment”). This includes detailed characterization using our forensic chemistry and characterization capabilities, including higher order structure assessment, particle measurements and characterization, product performance testing, testing for and characterization of potential new impurities and general compliance to regulatory guidance, requirements and/or health authority specifications.

  • The combination product functionality is a function of the properties of the device (such as a prefillable syringe) and the formulated drug product, as well as their interaction and stability over storage time. Our DPS team has a wide experience with drug/device functionality testing (such as injectability) as well as the necessary equipment to thoroughly characterize and optimize the necessary parameters to ensure successful functionality throughout the shelf-life.