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

14/15 December 2023

Course No 20605

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

All times mentioned are CET.

Our Service

Costs

*ECA-Member:**	EUR 1690,--
*Non ECA Member:**	EUR 1890,--
*EU/GMP Inspectorates:**	EUR 945,--
*APIC Member Discount:**	EUR 1790,--

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

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

Objectives

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.

Background

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 https://www.gmp-compliance.org/training/online-training-technical-information 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.

Programme

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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