Stephan Löw
CSL Behring
Referent:innen
Dr Ulf Gurok
Roche Diagnostics
Dr Sabine Hauck
dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Basics & Regulatory Requirements / Overview and Step in into the field of Biotechnology /
Process Overview: From Manufacturing of APIs to Fill&Finish / Regulations & Challenges for ATMPs
Zielgruppe
This course is addressed to all people interested in pharmaceutical biotechnology related to GMP manufacturing, analytics, product release and marketing authorisation.
Zielsetzung
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.
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.
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.
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.
Programm
What is Biotechnology - Introduction to the World of Biotechnology
- What is biotechnology
- Historical and modern applications of biotechnology
- Key Technologies
- Medical and economic impact
Regulatory Requirements and Guidelines for Manufacturing Biopharmaceuticals
- Legal framework on biopharmaceuticals in the EU
- Guidelines (EU, US, ICH, etc.)
- Expectations and inspection findings
Manufacturing of Biotechnological APIs – Focus on Cell Culture Technologies and their Products
- Cell lines as production platforms
- The manufacturing process (cell culture, harvest, purification)
- In-process control and release Analytics
- Quality & regulatory aspects
Virus Reduction
- Regulatory background
- Relevant virus clearance studies and model viruses
- Common and new methods of virus reduction
- TSE Safety
Manufacturing of Biotechnological APIs – Focus on bacteria & yeast (E. coli / S. cerevisiae)
- Suitability of raw materials and consumables
- Media and buffers
- Water as raw material
- Fermentation
- Cell harvesting
- Purification
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 (MCB/WCB)
- From initial cell to final production cell
- Establishing of cell banks
- Where does GMP start during cell banking
- Storage of cell banks
- Maintenance of cell banks
Fill & Finish of Biotechnological Products
- Aseptic processing and media fill
- Liquid formulation or lyophilisation?
- Stability tests of biopharmaceuticals
ATMPs - Regulations & Challenges
- Classification of ATMPs
- Regulatory landscape
- GMPs for ATMPs
Microbiological Aspects of Biotechnological API Manufacturing
- Microbiological control of the manufacturing process
- QC methods (Bioburden, Endotoxins)
- Handling of contamination events
Weitere Informationen
Venue
Qube Hotel Bahnstadt
Grüne Meile 21
69115 Heidelberg, Germany
Phone +49 (0) 6221 18799 0
bahnstadt@qube-heidelberg.de
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the conference. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT)
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on both days, and all refreshments. VAT is reclaimable.
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.
Conference language
The official conference language will be English.
Social Event
On the evening of the first course day, the participants are cordially invited to a dinner. This event is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Contacts
Questions regarding content:
Mr Clemens Mundo (Operations Director), +49 (0) 6221 84 44 42, mundo@concept-heidelberg.de
Questions regarding organisation:
Ms Julia Grimmer (Organisation Manager), +49 (0) 6221 84 44 44, julia.grimmer@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 20 October 2026, 9:00 h – 17:00 h
(Registration and coffee 8:30 – 9:00 h)
Wed, 21 October 2026, 8:30 h – 15:30 h
(Registration and coffee 8:30 – 9:00 h)
Wed, 21 October 2026, 8:30 h – 15:30 h
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Biotech Manager"
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E-Mail: info@concept-heidelberg.de
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