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Biologics

Biologics Congress Europe – Slide release

Presented at the 4th Biologics & Biosimilars Congress, these free slides are now available to download and share with your colleagues.

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Antibody Drug Conjugates: Bioanalytical Assay Challenges and Strategies

Antibody-drug conjugates (ADCs) combine the high specificity of a monoclonal antibody (mAb) for a target antigen with the highly potent cytotoxic activity of small-molecule drugs. Although the concept behind ADCs is relatively simple, the successful design and development of ADCs is a complex task. Similar to other biotherapeutics, the understanding of Pharmacokinetics (PK), Pharmacodynamics (PD), and Absorption, Distribution, Metabolism, and Excretion (ADME) properties of ADCs is critical for their successful development.

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Presentation Slide Release: Biologics Discovery and Development

Presented at the 3rd Biologics and Biosimilars Congress, these 3 sets of slides are available to download and share with your colleagues.

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Developing and Manufacturing Innovative Biologics: Obstacles and Opportunities

In this 30 minute presentation, Ralf Schumacher discusses developing and manufacturing biologics. Translating discovery knowledge into process design, technology upgrading and gated development paradigms are explored.

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Assays in clinical trials and pharmacovigilance

Assays are crucial during pre-clinical and clinical trials, and for pharmacovigilance. By this stage, the molecule has already been fully profiled with a mechanism of action, and efficacy and safety are now being assessed in vivo.

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The pivotal role of assays in biologic and biosimilar discovery and development

The quality, accuracy and reliability of assays is particularly critical when developing biologics and biosimilars. Assays for biologics are more complicated than for small molecules, often relying on assays which provide relative measures in contrast to the more absolute measurements gained from standard crystallisation or purity profiles.

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ADCs Design and Optimisation

My research activity focuses on the exploration of new drug delivery technology (categorised into polymer complex/conjugates, nanomedicine, and various types of drug delivery formulations) and the application of validated drug delivery technology to NCE candidates in early/exploratory research stages.

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