Introduction

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

The following topics are covered:

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
An introduction to immunoassays is provided covering assay formats, technologies and with supporting examples using 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
This section introduces the concept of immunogenicity, the importance in preclinical and clinical studies and discusses 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 detail typical ADME properties of large molecules, why we do or do not conduct certain studies, and how best to 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.

Intended audience:
This course is intended for DMPK-PD/Bioanalytical scientists (as well as others involved in nonclinical or early clinical development) who wish to learn more about the key aspects influencing large molecule drug development.

Schedule:
The course is usually delivered in a face to face, residential style format over 3 days. Designed as an interactive course, content is delivered using a combination of lectures and interactive tutorials.

Consistent with the DMDG core principles, the interactions and networking between delegates and with tutors is encouraged at all times including opportunities to connect at coffee breaks and at dinner each evening.

Logistics:
The course runs every 2 years for a maximum of 40 delegates.

Location:
In 2022, this course will be delivered from our DMDG training base at Burleigh Court, Loughborough, UK.

Tutors:

  • Kevin Brady – Course Leader (UCB)

  • Robert Nelson (Labcorp)

  • Jo Goodman (Astra Zeneca)

  • Richard Kay (Cambridge University)

  • Mark Penney (UCB)

  • Rob Wheller (LGC)

  • Rob Wilson (DLRC)

  • Graeme Clark (Concept Life Sciences)