An Introduction to Biopharmaceuticals: A Beginner’s Guide

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Course Overview

 

The biopharmaceutical industry has grown significantly in recent years and continues to drive innovation through breakthrough therapeutic products. You will hear a lot about the biopharmaceutical industry and biological therapeutic products. But what are they? What makes them so effective? What challenges must be overcome when developing a biopharma product? What is a biosimilar?

 

This training course will provide you with a comprehensive overview of how biopharmaceutical products are developed and manufactured. This course is designed for non-technical people who require a basic understanding of the science and technology. Once completed, you will understand the major differences between biotech products and traditional pharmaceutical products. You will also understand the major challenges of developing and manufacturing a biopharma product including regulatory, clinical and quality issues.

Learn more about how we deliver live online training.

 

What is included?
  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session

Key Learning Objectives

  • Understand the science and key terminology to support you in your role
  • Gain a comprehensive overview of biopharmaceutical development and manufacturing
  • Examine the main operations of a biopharmaceutical manufacturing process
  • Improve your understanding of the key techniques used by the biotech industry
  • Appreciate the major differences between biopharmaceutical and traditional pharmaceuticals
  • Examine the major challenges when developing/manufacturing a biopharmaceutical product which can impact timelines and costs
  • Briefly examine advanced therapies (CGT) and discuss the differences with biotech

 

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.

 

This course is specifically designed for professionals who are not technical experts but wish to understand the differences between biopharma and traditional pharmaceuticals. It will provide you with comprehensive overview of the sector to support you in your job.

Sectors and job roles this course is most suited for include:

  • Technical professionals starting out in the biopharma who require a comprehensive overview
  • All supporting functions such as marketing, finance and IT
  • Investment Professionals
  • Recruitment Professionals
  • Legal and IP Professionals
e-learning options

Want to train your team, department or whole organisation? This course can be developed into on-demand e-learning and hosted by Educo Life Sciences or on your own LMS platform.

Email [email protected] for more information.

 

 

Could your team benefit from this course?

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.

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• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for 2 weeks after the training