Introduction

Synopsis
This course serves as an introduction of DMPK/Bioanalytical/Immunogenicity aspects of “large molecules” to the attendees. Molecules to be discussed in the course include oligonucleotides, antibodies, antibody fragments and proteins. The following topics will be discussed.

LC-MS/MS
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.

Immunoassays
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.

Immunogenicity
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.

ADME and PK/PD
These sections will detail typical ADME properties of large molecules, why we do or do not conduct certain studies, and how do we evaluate PK/PD relationships for large molecules. Particular attention will be given to restrictive distribution, functional aspects of large molecules and target behaviours influencing disposition.

General Information
The course cost includes 3 nights accommodation at the Pullmann Hotel, Brussels Midi. Inclusive to this is lunch on Wednesday through to Friday, as well as Dinner on Tuesday and Thursday evenings. Wednesday evening is for delegates to arrange as they wish, as we are very close to the heart of Brussels. Morning and afternoon coffee and light snacks will also be provided.

Delegates are requested to arrive by approximately 6pm on Tuesday 15th October and it is anticipated that the course will finish at approximately 2pm on Friday 18th October.