Enrol before | 23 August to save £400 | 22 September to save £200
Discount has been applied to the price above. VAT, if applicable, will be added. The full price for the classroom option is £1,495 and the live online option is £1,395.
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.
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 a Hybrid Training Course?
You decide what format is best for you. The course is delivered as a classroom (in-person) course that is also delivered online. You can decide whether you would like to attend in person or online. The price is dependent on the option.
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.
The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. For classroom attendees, refreshments are served from 8:30 AM. For online attendees, you will receive joining instructions.
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
16 August | 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.
Day 1
10 October 2023
Overview of assays in biologics
Clinical assessment and 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 safety & immunogenicity
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
11 October 2023
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 for both PK/Immunogenicity and potency assays.
Curve fitting in bioassyas
Weighing the curves
Cut point analysis immunogenicity
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
Qualification and validation of bioassays in clinical and manufacturing
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
Review ICH M10, what’s new and different
Impact of M10 guideline on current bioanalytical validation
Review the difference between bioanalytical (clinical) and analytical (manufacturing) assays
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.
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.
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.
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.
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.
