Dr. Sabine Hauck
dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Referent:innen
Dr. Marcus Fido
Mfi Bio-Consulting
Dr. Paul Stockbridge
Stockbridge Biopharm Consulting
Zielsetzung
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.
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.
Hintergrund
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.
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.
Zielgruppe
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.
Programm
Gesamtes Programm als PDF herunterladen
Programme Day 1
What is Biotechnology - Introduction to the World of Biotechnology
What is Biotechnology - Introduction to the World of Biotechnology
- Definition of biotechnology / biopharmaceuticals
- Small chemical entities versus biopharmaceuticals
- History of manufacturing, production, & Analytics
- View into different areas of business segments
- Market figures and future investigations
GMP and Regulatory Guidelines in Biotechnology
- European Guidelines
- FDA Guidelines
- ICH
- ISPE
- PIC/S
- PDA
- WHO
- APIC
- ISO
Manufacturing of Biotechnological APIs – Focus on Cell Culture Technologies and their Products
- Different cell lines as production platforms
- The manufacturing process in development (upstream, upscaling, harvest, downstream)
- Contamination risks during cell culture, manufacturing, harvesting & DSP
- Analytical methods for product characterisation
- 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 material
- TSE safety of raw materials
- Water as raw material
- Fermentation
- Cell harvesting
- Purification
- Filling of bulk APIs
- From drug substance to drug product
Programme Day 2
GMP Requirements for Rooms and Personnel
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 product
- Manufacturing
- Storage
- Quality control
- Release documentation
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
From (Pre)clinical Studies to Market Authorization
- Clinical studies and drug regulatory affairs for biotechnological products
- From preclinical to late clinical studies
- Bioanalytics applied for clinical Trials
- Centralised procedure is a favourite scenario
- Changes and variations of biotechnological products
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* 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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Seminarprogramm als PDF
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