Live Online Training - Pharmaceutical Biotechnology for Non-Biotechnologists
Course No 18425
All times mentioned are CET.
Costs
There is unfortunately no recording available for this Online Training Course. However, are you interested in participating in an upcoming Live Online date of this Training Course? Or do you need any assistance on our Training Courses & Conference programme? Then simply use the following contact form to send us your request.
If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org
Speakers
Dr Markus Fido, MFI Bioconsulting, Austria
Dr Sabine Hauck, Leukocare, Germany
Dr Paul Stockbridge, Stockbridge Biopharm Consulting, UK
Dr Sabine Hauck, Leukocare, Germany
Dr Paul Stockbridge, Stockbridge Biopharm Consulting, UK
Objectives
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.
Background
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.
Target Group
This Live Online Training is addressed to all people interested in pharmaceutical biotechnology related to GMP manufacturing and marketing authorisation
Technical Requirements
For our Live Online Trainings and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programme
Programme Day 1
09.00 – 09.15 h Welcome/Organisationals
09.15 – 10.30 h
What is Biotechnology/Introducing in Biotechnology
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
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
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
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
Questions and Answers
Programme Day 2
08.30 – 09.15 h
GMP Requirements for Master and Working Cell Banks
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
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
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
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/ 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
Fill and Finishing
- Aseptic processing and media fill
- Liquid formulation or lyophilisation?
- Stability tests of biopharmaceuticals
16.15- 17.00 h
Questions and Answers
Questions and Answers
GMP Conferences by Topics
- Quality Assurance
- GMP in Biotechnology
- Microbiology
- Regulatory Affairs
- GMP in Pharmaceutical Development
- Quality Control
- GDP
- Sterile / Aseptic Manufacturing
- Computer Validation
- Validation
- Technical Operations
- GMP for APIs and Excipients
- Medical Devices
- GMP Basic Training Courses
- Packaging
- Data Integrity