Dr. Marcus Fido
Mfi Bio-Consulting
Referent:innen
Dr. Sabine Hauck
dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Dr. Paul Stockbridge
Stockbridge Biopharm Consulting
Zielsetzung
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.
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.
Hintergrund
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.
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.
Zielgruppe
This Live Online Training is addressed to all people interested in pharmaceutical biotechnology related to GMP manufacturing and marketing authorisation.
Technical Details:
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Programm
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
Recording from 14/15 December 2023
Duration of Recording: 11 h
| ECA-Member*: | € 1690,- |
| Regular Fee*: | € 1890,- |
| EU/GMP Inspectorates*: | € 945,- |
| APIC Member Discount*: | € 1790,- |
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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