Pharmaceutical Biotechnology for Non-Biotechnologists

Pharmaceutical Biotechnology for Non-Biotechnologists

Berlin, Germany

Course No 9138


Costs

This conference already took place.

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, VelaLabs, Austria
Arjan Langen, MSD, The Netherlands
Dr Paul Stockbridge, Stockbridge Biopharm Consulting, United Kingdom

Objectives

This course 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 Course is addressed to those interested in pharmaceutical biotechnology related to GMP manufacturing and marketing authorisation.

Programme

What is Biotechnology/Introducing in 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 Guidelines in Biotechnology
European Guidelines
FDA Guidelines
ICH
ISPE
PIC/S
PDA
WHO
APIC
ISO

Manufacturing of biotechnological API –
Focus on E. coli
Suitability of raw material
TSE safety of raw materials
Water as raw material
Fermentation
Cell harvesting
Purification
Filling of bulk API
From drug substance to drug product

Manufacturing of Biotechnological API –
Focus on Cell Culture
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

Clinical Studies/ 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

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

GMP Requirements for Master and Working Cell Banks
From initial cell to product
Manufacturing
Storage
Quality Control
Release Documentation

Virus Reduction
Regulatory background
Relevant and model viruses
Common and new methods of virus reduction
TSE Safety

Fill and Finishing
Aseptic processing and media fill
Liquid formulation or lyophilisation?
Stability tests of Biopharmaceuticals

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