Pharmaceutical Biotechnology for Non-Biotechnologists - Live Online Training An Overview and Insight in Pharmaceutical Biotechnology

Pharmaceutical Biotechnology for Non-Biotechnologists - Live Online Training

Course No 20605

This course is part of the GMP Certification Programme "ECA Certified Biotech Manager". Learn more.

All times mentioned are CET.


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Dr Markus Fido, MFi Bio-Consulting, Austria
Dr Sabine Hauck, Leukocare, Germany
Dr Paul Stockbridge, Stockbridge Biopharm Consulting, UK


This Live Online Training will provide non-Biotechnologists with an overview and insight in pharmaceutical biotechnology. It will also present the opportunities of biotechnology in GMP manufacturing.

Common aspects of production analytics will be discussed just as well as regulatory aspects of Biopharmaceuticals (bacteria and cell culture) and specific requirements on clinical studies and marketing authorisation. It will furthermore concentrate on topics like virus reduction, cell banking, media fills and dedicated rooms and personnel.


From a historical view, biopharmaceuticals are no new business. Antibiotics and vaccines have been well known for more than 60 years. But with the marketing authorisation of the first pharmaceutical product, produced by gene technology in the 80s, a new era of biopharmaceutical and biotechnological development and manufacturing started.

In 2007, 20% of all new released pharmaceuticals were biopharmaceuticals. Future pharmaceutical products based on biotechnology and the biosimilars (Biogenerics) will become more and more important and present a higher share of pharmaceutical products.

Target Group

This Live Online Training is addressed to all people interested in pharmaceutical biotechnology related to GMP manufacturing and marketing authorisation.

Technical Requirements

We use WebEx for our live online training courses and webinars. At you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.


What is Biotechnology - Introduction to the World of Biotechnology
  • Definition of biotechnology/biopharmaceuticals
  • Small chemical entities versus biopharmaceuticals
  • History of production and Analytics
  • View into different areas of the business 
  • Market and future investigations
GMP and Regulatory Guidelines in Biotechnology
  • European Guidelines
  • FDA Guidelines
  • ICH
  • ISPE
  • PIC/S
  • PDA
  • WHO
  • APIC
  • ISO
GMP Requirements for Master and Working Cell Banks (MCB/WCB)
  • From initial cell to product
  • Manufacturing
  • Storage
  • Quality Control
  • Release documentation
Manufacturing of Biotechnological APIs – Focus on E. coli
  • Suitability of raw material
  • TSE safety of raw materials
  • Water as raw material
  • Fermentation
  • Cell harvesting
  • Purification
  • Filling of bulk APIs
  • From drug substance to drug product
Manufacturing of Biotechnological APIs – Focus on Cell Culture Products
  • Different cell lines as production platforms
  • The manufacturing process (up/downstream)
  • Contamination risks during cell culture and production
  • Analytical methods for product characterisation
  • Quality & regulatory aspects
Virus Reduction
  • Regulatory Background
  • Relevant and model viruses
  • Common and new methods of virus reduction
  • TSE safety
GMP Requirements for Rooms and Personnel
  • Regulatory requirements
  • Balancing GMP and laws of gene technology
  • Zone concept
  • Flow of material and personnel
  • Clean Rooms
  • Cleaning and hygiene procedures
  • Monitoring and validation
Fill and Finish for Biotechnological Products
  •  Aseptic processing and media fill
  •  Liquid formulation or lyophilisation?
  •  Stability tests of biopharmaceuticals
ATMPs - Regulations and Challenges
  • Classification of ATMPs
  • Regulatory landscape
  • GMPs for ATMPs
Clinical Studies - Market Authorisation
  • Clinical studies and drug regulatory affairs for biotechnological products
  • From preclinical to clinical studies
  • Bioanalytics during clinical trials
  • Centralised procedure is favourite
  • Changes and variations of biotechnological products

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