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    Regulated bioanalysis of biopharmaceuticals – mass spectrometry as analytical platform

    Join us at the upcoming Good Morning Meeting and learn about Regulated bioanalysis of biopharmaceuticals – mass spectrometry as analytical platform

    Bioanalysis of peptides, proteins and oligonucleotides by LCMS is a developing science and an addition to the still leading ligand binding analytical techniques. LC-MS can generate complementary information to LBA and therewith provide more accurate insights in PK/PD behavior of a specific macromolecule.  

    A broad array of mass spectrometry technologies and sample preparation methods can be employed to produce more robust and compliant data.

    QPS would like to discuss and share experiences on benefits and drawbacks faced when using LC-MS in regulated bioanalysis of large molecules.

    Date: May 11, 2017
    Time: 08:30 – 10:30
    Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, Copenhagen S – Ground floor

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    PROGRAM

    08.30-09.00 Coffee and networking
    09.00-10.00

    Introduction to regulated bioanalysis of biopharmaceuticals and choice of analytical
    platform
    Fabrizia Fusetti, Ph.D, Director Biologics Mass Spectrometry, QPS Netherlands B.V.

    Regulated bioanalysis of biopharmaceuticals – mass spectrometry as analytical
    platform – discussion

    Marion Kranenborg, Ph.D., Senior Director Compliance and Scientific Support, QPS Netherlands

    Q & A

    10.00-10.30 Networking

     

    SPEAKERS

    Fusetti_QPS-photo

    Fabrizia Fusetti, Ph.D, Director Biologics Mass Spectrometry, QPS Netherlands B.V.
    Fabrizia Fusetti is group leader in the department of Bioanalysis at QPS Netherlands B.V.  Technological focus of her team is the development of bioanalytical mass spectrometry methodologies for the (regulated) determination and characterization of therapeutic proteins, monoclonal therapeutic antibodies, ADCs, peptides and oligonucleotides. She obtained her PhD in Biotechnology at the University of Milan (Italy) and before joining QPS she dedicated several years of her academic research at the University of Groningen (The Netherlands) to mass spectrometry based proteomics projects. 

    Marion Kranenborg

    Marion Kranenborg, Ph.D., Senior Director Compliance and Scientific Support, QPS Netherlands B.V.
    Marion Kranenborg joined QPS NL in 1999. As project manager she was responsible for numerous projects in PK bioanalysis, ADA bioanalysis and biomarkers bioanalysis; in multiple species, in multiple drug development phases and employing all available techniques. With the growth of the business Marion had other functions and responsibilities within QPS NL, but always within the laboratory division. Currently, she is the Senior Director Compliance and Scientific Support. In addition, Marion is (delegated) GLP Test Facility Manager as specified in OECD GLP. With her team she focusses on scientific support and representation, management and maintenance of the lab quality system, training and education and regulatory support. Prior to joining QPS, Marion gained extensive academic and industrial experience. Marion received her Biochemistry degree and training in the Netherlands.

     

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