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(Bio) Assays in Pre-Clinical and Clinical Development for Biopharmaceuticals and Cell & Gene Therapies

Dates in 2025 | Register Your Interest

Original price was: £1,395.00.Current price is: £995.00.

The price is for all sessions Register for Module 1 – Free

Master early-stage bioassay techniques such as cell-based assays, biostatistics, validation and qualification

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Register For Module 1 | Free-To-Attend

 

Module 1 of this course is free to attend and delivered online. Register to receive joining instructions for the live event, recording and presentation slides.

Register Early To Save

 

Enrol before 27 September to save £400

Discount has been applied to the price above. VAT, if applicable, will be added.

Course Overview

 

Bioanalysis and immunogenicity testing are required for biopharmaceuticals and cell & gene therapy products to understand efficacy and safety during pre-clinical and clinical development.

 

In this course, you will learn about conducting (bio)assays for biopharmaceutical and cell & gene therapy (ATMP) products during pre-clinical and clinical development. You will specifically examine the development, validation and qualification of ligand-binding and cell-based assays for PK/PD/Toxicology. You will also discuss biostatistics topics such as curve fitting, cut point analysis and DoE.

 

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

Course Dates

 

Find out when this course is running so you can plan your training.

2025 Dates TBC

1 Week Live Online Training

Key Learning Objectives

 

  • Gain a comprehensive understanding of bioassays throughout biological and cell & gene therapy early development
  • Develop strategies to overcome immunogenicity and ADAs
  • Learn best practices to set up a PK assay
  • Gain the skills to successfully validate and qualify your bioassays during pre-clinical and clinical development
  • Understand the basics biostatistics to analyse your assays competently
  • Discuss DoE in bioassays and learn how it can support you in your role

What Is Included In A Live Online Course?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Bitesize learning
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 4 to 5 weeks after the last session
  • Reinforcement session delivered 4 to 5 week after the course (online) providing you with extra time with the trainer
  • A validated certificate of attendance available for you to download

Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)

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 subsequent questions and challenges
Introductory Online Module
FREE to Attend | Live & Recorded

2025 Date TBC | 60 mins | 1:00 PM UK

Delivered Online

Overview of assays in biologics

During the first session we will explore the special nature of biologics and what makes them so complex. We will walk through the fundamentals of the clinical and manufacturing related assays we need to set up to ensure safety & efficacy of our biologics

  • Large versus small molecules
  • Clinical assessment of efficacy and safety
    • Fundamentals of PK/PD/Immunogenicity assays
  • Manufacturing of clinical batches
    • Fundamentals of potency assays

Register For Online Session | Free

There are limited spaces on the introductory session. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.

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Session 1

2025 Dates TBC | 120 mins | 1:00 PM (UK time)

Clinical Assessment of drugs – PK assay set up and development   

  • Physicochemical properties of the plates
  • Mechanism of how antibodies (or other capture molecules) are bound to the plate
  • Blocking
  • Detection antibodies
  • Matrix/ excipients
  • Development reactions such as with HRP
  • Problems along the way
Session 2

2025 Dates TBC | 120 mins | 1:00 PM (UK time)

Immunogenicity

  • Intro to Anti-Drug Antibodies (ADAs)
  • Examine the clinical impact
  • Anti-drug antibody assays and strategy

Practical exercises, group work and case studies

Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.

Session 3

2025 Dates TBC | 180 mins | 1:00 PM (UK time)

Cell-based assays

  • Cell-based endpoints
  • The cell as the source of variability
  • Special focus: neutralizing anti-drug antibody assays
  • Cell banking for cell-based assay

Biostatistics

  • Curve fitting in immune/bioassays
  • Weighing the curves
  • Cut point analysis Immunogenicity
  • Design of Experiments (DoE)
  • Screening vs optimisation
Session 4

2025 Dates TBC | 120 mins | 1:00 PM (UK time)

Qualification vs Validation

  • Short history
  • The GxP system
  • Guidelines for bioanalytical method validation
  • ICH M10, what’s new and different
  • Core parameters
  • Practical execution and acceptance criteria
Session 5

2025 Dates TBC | 120 mins | 1:00 PM (UK time)

The curious case of cell & gene therapy products

  • A brief introduction to gene and cell therapies
  • Clinical development
  • Immunogenicity of viral-based gene therapies
  • What do we need from a (bio)analytical point of view?
  • Examine the CGT-specific guidelines

Practical exercises, group work and case studies

Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.

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 all professionals who perform bioassays and immunogenicity studies during early-stage development such as pre-clinical and clinical. The course is focused on bioassay methods and techniques (ELISA) and is designed to help you conduct assay tests competently. Attendees should have a basic understanding of bioassays or immunoassays.

Free Online Module and Pricing
  • Module 1 is free to attend and is delivered online and is recorded.
  • To enrol onto module 1, please submit your details in the form.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
  • There are price tiers for this course. The dates of these are at the located above the course overview.

Frequently asked questions (FAQs)

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.

Complete our contact form by following the link. Get in touch.

*

• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• In the event we do not have enough people on one of the options we will contact you to discuss switching. If for example we ask you to switch from classroom (in-person) to live online, we will refund you the difference in price.

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(Bio) Assays in Pre-Clinical and Clinical Development for Biopharmaceuticals and Cell & Gene Therapies

Dates in 2025 | Register Your Interest

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