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

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

Session 1

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.

• 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

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.

• 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.

Session 3

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.

• 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

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 4

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).

• 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.