Programme Day 1
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
- 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