New Courses for 2025
We have two new courses for bioassays and potency assays in 2025.
The price is for all sessionsÂ
Learn more about bioassay techniques and methods to help you design and conduct successful ELISA studies
We have two new courses for bioassays and potency assays in 2025.
Learn more about the new course by following the link >>Learn More<<
Learn more about the new course by following the link >>Learn More<<
Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.
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.
Find out when this course is running so you can plan your training. Scroll down to view the full agenda.
We have two new courses for bioassays and potency assays in 2025.
Learn more about the new course by following the link >>Learn More<<
1 Week Live Online Training
Follow the link above to register.
1 Week Live Online Training
Follow the link above to register.
Learn more about the new course by following the link >>Learn More<<
1 Week Live Online Training
Follow the link above to register.
1 Week Live Online Training
Follow the link above to register.
If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.
For a quote, complete our contact form by following the link. Get in touch.
We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.
For more information, complete our contact form by following the link. Get in touch.
Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)
Pre-course
Action Plan
Reinforcement Session
60 mins | 1:00 PM UK
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
150 mins | 1:00 PM (UK time)
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.
150 mins | 1:00 PM (UK time)
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.
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.
150 mins | 1:00 PM (UK time)
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.
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.
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.
150 mins | 1:00 PM (UK time)
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).
Qualification and validation of bioassays in clinical and manufacturing
In this last module, we will examine validation of bioanalytical 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.
There is a free-to-attend training module for this course. When you register you will have full access to the live session, recording and presentation slides.
To learn more about what is covered in the module and when it is, follow the link below.
Polpharma Biologics (verified owner) –
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Bio-Rad –
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Bio-Rad –
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Bio-Rad –
The course was really relevant to my current position, and I picked up much better understanding of BioAssays in the market segment I work in. Melody was extremely knowledgeable and provided great background information as well as covering some topics in great detail. The course was very well structured and I would certainly consider attending another relevant course in future.
Saudi Food and Drug Authority (SFDA) –
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ILC Therapeutics –
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Roche (verified owner) –
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Strathclyde University –
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