DMDG Large Molecules Course

7 - 10 October 2014, United Kingdom

This course is organised by the Drug Metabolism Discussion Group.

The course cost will be £860 and include 3 nights accommodation at Burleigh Court Conference Centre and Hotel All food will be included from dinner on the evening of the 7th October until lunch on the 10th October.

Course Overview

The "large molecules” to be discussed in the course include oligonucleotides, antibodies, antibody fragments and proteins. The following topics will be discussed.

Most of the techniques that bioanalysts are familiar with for small molecule analysis may also be applied to allow quantification of larger biomolecules. Larger molecules however pose their own unique problems for LC-MS/MS analysis, spanning from their extraction from biological fluids through to the chromatography and MS/MS ionisation. These talks will present the many challenges and commonly used strategies to allow quantification of therapeutic peptides and oligonucleotides by LC-MS/MS, as well as proteolytic digestion based strategies for proteins which are too large to analyse intact.

The immunoassay presentations will aim to provide an introduction to immunoassays and build on this to discuss assay formats, technologies and support these concepts with case studies. Topics will include: Principle of mass action and how it affects all immunoassays; assay formats – how to run free, total and complex assays including the pros and cons of various formats and how best to analyse the data; critical reagents and technologies including MSD, Gyrolab, DELFIA and Luminex.

The immunogenicity section of the course will introduce the concept of immunogenicity, the importance in preclinical and clinical studies and discuss strategies to determine an immune response. Assay formats, examples of various technologies and the regulatory requirements will also be covered.

Absorption, Distribution, Metabolism and Excretion (ADME)
The concept of ADME for large molecules differs from that of small molecules. This presentation will introduce some of those differences with regards to small molecules as well as between the different types of large molecules. It will also introduce concepts that may influence the PKPD of the molecules.

Real-world examples will be used to illustrate the key differences in the PKPD of large molecules and the considerations that must be made when developing large molecules as therapeutics; from the initial stages of target selection through to pre-clinical characterisation and first-time-in-man trials.

The tutorials will aim to build on the information presented in the lectures and demonstrate, via small break out groups, the practical application of many of the biopharm specific properties in the framework of a fictional drug development process from candidate to clinical trials (FIH).
Burleigh Court

Burleigh Court, Loughborough, United Kingdom

Organised by
Drug Metabolism Discussion Group - DMDG
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