Analysing Bioassays and Immunoassays
This virtual classroom course will cover basic processes necessary for designing assays and analysis data from such bioassays, setting up meaningful system suitability acceptance criteria and designing validation plans. Important considerations will be examined such as choosing the appropriate non-linear or linear regression fit, calculating correct residual weights, computing practical limits of sensitivity and acceptable error, and measuring non-parallelism and potency.
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses.
Over 2 days students will learn through:
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Revisiting recorded sessions with unlimited access for 30 days
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact email@example.com.
What will you learn?
Analyse Biological Samples
Set up smart and robust immuno- and bio-assays to analyse any biological sample for potency, concentration and immunogenicity
Validate bioassays to meet regulatory requirements
Generate realistic potency assay criteria that meet regulatory requirements
Understand current discussions in bioanalytical community on assay parameters and regulatory requirements
Analyse and troubleshoot biological assays comprehensively
Who is this course for?
This course is designed for all individuals who develop, validate, perform or monitor bioassays or immunoassays. Individuals who develop assay methodologies, assign computational and analysis criteria, measure and validate performance characteristics, evaluate and troubleshoot problem assays, or who are responsible for the quality of the data will benefit from the lessons and examples presented.
Attendees should have a basic understanding of bioassays or immunoassays.
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.
Meet the Course Leader
As a trained immunologist and virologist, Melody Janssen entered the fascinating world of biologics during her PhD.
She focused on investigating why biologics induce the formation of anti-drug antibodies especially in the presence of protein aggregates. After obtaining her PhD, Dr. Janssen established herself in the areas of bioanalysis and immunogenicity testing by spending numerous years as a project leader, trainer and senior expert in CROs and 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.
During her role as the head of non-clinical development at Mymetics, a viral vaccine company, she also extended and added to her expertise the production of biologics, vaccines and ATMPs and the aspects of potency assays and GMP. Currently Dr. Janssen focuses on freelance and interim management projects including (non-) clinical immunogenicity assessment, production of vaccines and biologics and teaching bioanalytical method validation workshops across Europe (and sometimes beyond).