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