Course Outline

Course Information

• The course begins at the time stated at the top of the page
• The course is broken up into modules outlined below
• There will be breaks between modules

Session 1

120 mins 

Module 1: Introduction to the biopharmaceutical industry

• Historical perspective
• Diversity of biotechnology products
• Product development overview
• Examine the fundamental differences between biopharmaceuticals and small molecules (pharmaceuticals)
• Product development overview – manufacturing & (pre) clinical

Module 2: Examine the science of biopharmaceuticals

This module will provide you with an overview of how biological systems work. It will then examine how the biotech industry utilises those systems to generate the desired end products.

• Overview of how a cell works
• Examine protein synthesis in a cell
• Examine how the scientists use biological systems to produce their therapeutic product (protein)
• Understand the basics of:
  • Re-expression of proteins
  • Recombinant DNA techniques
  • Monoclonal antibodies – from mouse to human

Module 3: The biopharmaceutical manufacturing process

Now you know the science behind biopharmaceuticals, this module will examine the manufacturing process from start to finish.

• Examine key terminology within manufacturing
• Cell lines – the process of immortalising cells for production
• Product recovery and purification
• Formulation design of biopharmaceuticals
• Analysis of biopharmaceuticals and batch release

Session 2

120 mins

Module 4: Examine major challenges during biopharmaceutical development and manufacturing

In this module you will examine some of the major challenges faced by companies when developing a biological product such as manufacturing costs, regulatory problems and analytical issues.

• Economics of creating a biotech manufacturing site or outsourcing
• The concept of a virtual biotech
• Overcoming regulatory hurdles
• Safety and efficacy – bioanalytical testing of biopharmaceuticals

Module 5: Other key topics

In this module you will briefly examine other important topics you should be aware.

• Biosimilars and comparability, equivalence and biosimilarity
• Examine biologic development during pre-clinical and clinical trials.
• New modalities such as Cell and Gene therapies

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 biotech/CGT companies. She has worked on numerous biopharmaceutical products and is an expert on all areas of biopharmaceutical development and manufacturing.
Dr. Janssen has extensive experience of the regulatory frameworks (EMA, FDA etc.) for biopharmaceutical development/manufacturing. Ultimately Melody is aware of the many challenges biopharmaceutical companies face when developing a therapeutic product.

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.

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.