Programme Day 1
09.00 – 09.15 h Welcome/Organisationals
09.15 – 10.30 h
What is Biotechnology/Introducing in 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
10.30 – 10.45 h Break
10.45 – 12.15 h
GMP Guidelines in Biotechnology
- European guidelines
- FDA guidelines
- ICH
- ISPE
- PIC/S
- PDA
- WHO
- APIC
- ISO
12.15- 12.45 h
Questions and Answers
12.45 – 13.45 h Break
13.45 - 15.15 h
Manufacturing of Biotechnological APIs – Focus Cell Culture
- 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
15.15 - 15.30 h Break
15.30 – 17.00 h
Manufacturing of Biotechnological API – Focus E. coli
- Suitability of raw material
- TSE safety of raw materials
- Water as raw material
- Fermentation
- Cell harvesting
- Purification
- Filling of bulk API
- From drug substance to drug product
17.00 – 17.30 h
Questions and Answers
Programme Day 2
08.30 – 09.15 h
GMP Requirements for Master and Working Cell Banks
- From initial cell to product
- Manufacturing
- Storage
- Quality control
- Release documentation
09.15 – 10.00 h
Virus Reduction
- Regulatory background
- Relevant and model viruses
- Common and new methods of virus reduction
- TSE safety
10.00 – 10.15 h Break
10.15 – 11.30 h
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
11.30 – 12.00 h
Questions and Answers
12.00 – 13.00 Break
13.00 -14.00 h
Regulations and Challenges for ATMP
- Classification of ATMP
- Regulatory landscape
- GMPs for ATMP
14.00 - 15.00 h
Clinical Studies/ 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
15.00 – 15.15 h Break
15.15 – 16.15 h
Fill and Finishing
- Aseptic processing and media fill
- Liquid formulation or lyophilisation?
- Stability tests of biopharmaceuticals
16.15- 17.00 h
Questions and Answers