MAbs and ADCs: bioanalytical characterization for drug discovery

Apr
12
2018

Analytica Conference > GBM / Room 2 > Pharmaceutical Protein Characterization

12. Apr 2018
11:30-12:00 h  |  ICM - Internationales Congress Center München Room 2

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Subjects: 

Biotechnology & Life Sciences

|

Medicine/public health

|

Pharma & Diagnostics

Speaker: 

Dr. Roland Kellner 

(Merck KGaA)

Type:
Lecture
Speech: English

Monoclonal antibodies are quite challenging in their bioanalytical characterization. However, ADCs have an even increased level of complexity compared to naked mabs as their molecular composition is merging the features from NBEs and NCEs. More than 50 mAbs and 3 ADCs are on the market mainly to treat cancer. Accordingly, significant efforts are ongoing for next-generation antibody-related therapeutics, and about 60 ADC candidates are under evaluation in clinical trials. Bioanalytical characterization of mAbs was significantly improved in the last years namely by LC-MS technology. Intact mass analysis (top-down strategy) and detection of large subunits after proteolytic fragmentation are now routinely used. The design and optimization of ADCs rely on the assessment of additional quality attributes like drug distribution, average drug-to-antibody ratio (DAR) and free payload determination. A combination of mass spec and various chromatographical methods are mandatory to monitor all the way from a mAb to an ADC. In principle, the key steps necessary to make ADCs include (a) a well-defined target antibody, (b) a defined linker/payload system and optimization, (c) a specific conjugation chemistry, (d) a purification and characterization of the ADC product. DAR values are the basic feature to describe a successful synthesis. In vitro and in vivo biochemical and cellular assays are then of critical importance to study efficacy, stability and unwanted toxic effects. Overall the identification of a suitable therapeutic window is most critical for the development of an ADC candidate.
This presentation will focus on the early stage of an ADC development and the support of bioanalytics to achieve promising ADC candidates for clinical development.

Speaker
Dr. Roland Kellner, Merck KGaA Show Profile

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EntranceEast
EntranceNorth-West
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Outdoor areas
EntranceNorth-East
ConferenceCenter Nord
ICM
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EntranceWest
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Apr
12
2018

Analytica Conference > GBM / Room 2 > Pharmaceutical Protein Characterization

HPLC-MS and Native MS Approaches to the Characterization of Posttranslational Modifications in Biopharmaceuticals

12. Apr 2018
10:30-11:00 h  |  ICM - Internationales Congress Center München Room 2
Speaker: Prof. Dr. Christian Huber (University of Salzburg)

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Apr
12
2018

Analytica Conference > GBM / Room 2 > Pharmaceutical Protein Characterization

Challenges in the Characterization of Antibody-Drug Conjugates

12. Apr 2018
11:00-11:30 h  |  ICM - Internationales Congress Center München Room 2
Speaker: Dr. Anne Arnold (Immundiagnostik AG)

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Apr
12
2018

Analytica Conference > GBM / Room 2 > Pharmaceutical Protein Characterization

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12. Apr 2018
10:00-10:30 h  |  ICM - Internationales Congress Center München Room 2
Speaker: Martin Blüggel

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