Bioanalysis and immunogenicity testing for biopharmaceutical development

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Course Overview

 

On this course you will learn about conducting bioassays for biopharmaceutical products during pre-clinical and clinical development. You will specifically learn about the development and validation of ligand-binding and cell-based assays for PK/PD/Toxicology. You will also examine immunogenicity studies for biologics, biosimilars and vaccines. Once completed, you will have the confidence to design, develop, validate and monitor your analytical and immunogenicity studies.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

 

Key Learning Objectives

 

  • Examine the the GxP system
  • Understand qualification versus validation
  • Fit for purpose approach
  • Discuss immunogenicity
  • Validation of ligand and cell-based assays
  • Examine Design of Experiment (DoE) examples for Nab assays (ADA) 
Post Learning Implementation Plan (PLIP)

Pre-course

  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Agenda

Topics will include

  • Examine the the GxP system
  • Understand qualification versus validation
  • Fit for purpose approach
  • Discuss immunogenicity
  • Validation of ligand and cell-based assays
  • Examine Design of Experiment (DoE) examples for Nab assays (ADA)

 

Dr. Melody Janssen is an expert in bioanalysis and immunogenicity testing of biopharmaceuticals with in-depth experience as a project manager, trainer and senior expert in CROs and pharma/biotech companies. She worked predominantly on developing and validating ligand-binding and cell-based assays for PK/Tox and immunogenicity studies for biologics, biosimilars and vaccines and her work supported numerous regulatory filings. Dr. Janssen is experienced in the regulatory framework related to bioanalytical method establishment and validation including FDA, EMA, ICH guidelines and USP and Ph.Eur. monographs. She is frequently invited to speak at conferences on immunogenicity and bioanalytical testing, where she also leads conference specific workshops and seminars. She has shared her knowledge through trainings for over 10 years focusing on assay validation for bioanalytical, potency and immunogenicity assays. Recently she became a regular evaluator for the Swedish innovation agency, Vinnova, where her task is to assess the scientific rational and business proposals of start-up biotech companies competing for seed funding.

 

Based on her role as the head of non-clinical development at Mymetics, a viral vaccine company, she has gained experience on aspects related to the production of biologics and vaccines, potency assays and GMP.

 

For the last years, Dr. Janssen has been working as a freelancer for projects including non-clinical and clinical immunogenicity assessment, leading various late pre-clinical candidates to FIH, production of vaccines and biologics and teaching bioanalytical method validation workshops.

 

Her educational background is in infectious diseases and immunology, with a PhD in pharmaceutical sciences investigating the effect of protein aggregates on immunogenicity.

This course is aimed at professionals who conduct bioanalysis for PK/PD/Toxicology and immunogenicity studies during biopharmaceutical development (pre-clinical and clinical). Attendees should have experience of conducting bioassays or immunoassays as they will further advance their skills on this course.

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Or please summarise your objectives by completing the form below.

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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.