Pharmaceutical Biotechnology for Non-Biotechnologists
9/10 October 2024, Berlin, Germany
Course No. 21308
Speakers
Dr. Sabine Hauck
dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Dr. Marcus Fido
Mfi Bio-Consulting
Dr. Paul Stockbridge
Stockbridge Biopharm Consulting
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 and quality control.
Common aspects of product analytics will be discussed just as well as regulatory aspects of Biopharmaceuticals (bacteria, yeast and cell culture) and specific requirements on clinical studies and marketing authorisation. It will furthermore focus on topics like virus clearance reduction, cell banking, media fills and on dedicated rooms and personnel. The course will be completed by a presentation of the current comprehensive bodies of Legislation.
Background
From a historical view, biopharmaceuticals & biosimilars are no new business. Antibiotics and vaccines have been well known for more than 60 years. But with the marketing authorisation of the first biopharmaceutical product, produced by gene technology in the 80s, a new era of biopharmaceutical and biotechnological development and manufacturing started. Future pharmaceutical products based on biotechnology and Biosimilars as well as Biologics will become more and more important and present a higher share of pharmaceutical products.
Target Group
This course is addressed to all people interested in pharmaceutical biotechnology related to GMP manufacturing, analytics, product release and marketing authorisation.
Presentations / Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Testimonials
Seminar Programme as PDF