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Understanding Bioassays: Supporting the Development of Biologics

25 & 26 October 2022 | Classroom | London

£1,095.00

The price is for both days | Register for Module 1 – Free

Learn more about bioassay techniques and methods to help you design and conduct successful ELISA studies

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Enrol before | 2 September to save £400 | 30 September to save £200

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Course Overview

 

Bio and Immuno Assays are critical in the development and manufacture of biological products. During pre-clinical and clinical development bioanalysis and immunogenicity testing are required to fully understand efficacy and safety. In manufacturing potency assays play a major role quality control to ensure patient safety.

 

On this course you will examine the fundamental techniques and methods for conducting bioassays (ligand binding, cell based and functional). You will examine each step of an Enzyme-Linked ImmunoSorbent Assay (ELISA) from mechanisms and blocking to detection antibodies and development reactions. Once completed, you will have the confidence to navigate an bioassays in either a pre-clinical, clinical or manufacturing setting.

 

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 both online and classroom training courses. If you have any concerns about COVID-19 before registering on to the course, please read our COVID-19 commitment.

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 weeks after the last session
  • Full access to the Educo Post Learning Implementation Plan (PLIP)
  • A validated certificate of attendance available for you to download

What is Included in a Classroom Course?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Refreshments and lunch provided on each day
  • 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
  • Access to the Educo Life Sciences Training Portal before and after the course for additional learning materials

Download the Agenda

For more information about the course and to stay up to date with the latest updates complete the form below.

 

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Key Learning Objectives

 

  • Gain a comprehensive understanding of bioassays throughout biologic development and manufacturing
  • Build your technical knowledge of bioassays and immunogenicity testing
  • Examine the mechanisms of an ELISA and learn best practice to build your ligand binding assays
  • Analyse immunogenicity studies during clinical development
  • Understand the basics biostatistics to analyse your assays competently
  • Discuss QbD and DoE in bioassays learn how it can support you in your role space

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 Module 1
FREE to Attend | Live & Recorded

Sign up

 | 60 Mins | 

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 Module 1 | Free

There are limited spaces on module 1. 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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Module 2

| 90 Mins | 

Building an ELISA

Clinical assessment of a biologic is all about determining safety and efficacy. During clinical trials, blood samples are frequently taken for measurement of drug levels, biomarkers, and the presence of anti-drug antibodies.

In this session we will look at ‘the mother’ of all ligand binding assays – the enzyme-linked immunosorbent assay and how we can build an ELISA to measure the drug level of a monoclonal antibody.

  • 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
Module 3

| 90 Mins | 

Overview of immunogenicity studies

We will continue the clinical journey and now focus on safety and immunogenicity assays. Firstly, a brief introduction of immunogenicity will be presented, followed by a closer look at ligand binding based anti-drug antibody assays.

  • Immunogenicity: what is it
  • Clinical impact
  • Anti-drug antibody assays and strategy
Module 4

| 90 Mins | 

Understanding cell based assays

So far, we have been discussing ligand binding based assays. In this module we will introduce cells into the system and investigate how cells add to the complexity of our (bio) analytical methods.

  • Cell banking for non-producing cell lines
  • Cell assay related issues

 

Module 5

| 90 Mins | 

Statistics in bioassays

(Bio)assays cannot be interpreted without some fundamentals in biostatistics. In this session, we will take a brief journey into the pivotal things we need to understand to judge the quality of our data fitting.

  • Curve fitting in bioassyas
  • Weighing the curves
  • Parallelism

 

Module 6

| 90 Mins | 

Examining QbD and DoE in bioassays

In this module, we will take a peek at a hot topic in the (bio) analytical world: Quality by Design (QbD) and Design of Experiments (DoE).

  • A short history of QbD & DoE
  • How will it help the (bio)analytical world?
  • Case study

 

Module 7

 | 90 Mins | 

Validation of bioanalytical assays

In this last module, we will examine validation of bioanalytical assays.

  • Short history
  • The GxP system
  • Guidelines for bioanalytical method validation
  • Core parameters
  • Practical execution and acceptance criteria

 

 

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 work with bioassays such as pre-clinical, clinical and manufacturing. The course is focused on bioassay methods and techniques (ELISA) and is designed to help you conduct assays tests competently. Attendees should have a basic understanding of bioassays or immunoassays.

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

Classroom Training Information

The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. The final day may start and finish earlier to accommodate peoples travel arrangements.

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 Module 1
FREE to Attend | Live & Recorded

Sign up

15 February | 60 Mins | 1 PM UK

Register For Module 1 | Free

There are limited spaces on module 1. 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.

Day 1

25 October 2022

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

Building an ELISA

Clinical assessment of a biologic is all about determining safety and efficacy. During clinical trials, blood samples are frequently taken for measurement of drug levels, biomarkers, and the presence of anti-drug antibodies.

In this session we will look at ‘the mother’ of all ligand binding assays – the enzyme-linked immunosorbent assay and how we can build an ELISA to measure the drug level of a monoclonal antibody.

  • 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

Overview of immunogenicity studies

We will continue the clinical journey and now focus on safety and immunogenicity assays. Firstly, a brief introduction of immunogenicity will be presented, followed by a closer look at ligand binding based anti-drug antibody assays.

  • Immunogenicity: what is it
  • 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.

Day 2

26 October 2022

Understanding cell based assays

So far, we have been discussing ligand binding based assays. In this module we will introduce cells into the system and investigate how cells add to the complexity of our (bio) analytical methods.

  • Cell banking for non-producing cell lines
  • Cell assay related issues

 

Statistics in bioassays

(Bio)assays cannot be interpreted without some fundamentals in biostatistics. In this session, we will take a brief journey into the pivotal things we need to understand to judge the quality of our data fitting.

  • Curve fitting in bioassyas
  • Weighing the curves
  • Parallelism

 

Examining QbD and DoE in bioassays

In this module, we will take a peek at a hot topic in the (bio) analytical world: Quality by Design (QbD) and Design of Experiments (DoE).

  • A short history of QbD & DoE
  • How will it help the (bio)analytical world?
  • Case study

 

Validation of bioanalytical assays

In this last module, we will examine validation of bioanalytical assays.

  • Short history
  • The GxP system
  • Guidelines for bioanalytical method validation
  • Core parameters
  • Practical execution and acceptance criteria

 

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 work with bioassays such as pre-clinical, clinical and manufacturing. The course is focused on bioassay methods and techniques (ELISA) and is designed to help you conduct assays tests competently. Attendees should have a basic understanding of bioassays or immunoassays.

Most of our classroom courses are located at a venue in central London. The city has good transport links and is good place to socialise with fellow attendees. Accommodation is not included in the price. We recommend staying in a hotel within walking distance of the venue. Lunch and refreshments are included on all days where you will be able to interact with fellow peers and the trainers.

 

The course is held in the following venue:

Hallam Conference Centre, Cavendish Venues, 44 Hallam St, London, W1W 6JJ

 

Link to the Google Map

Pricing

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.

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.