Pharmaceutical Biotechnology for Non-Biotechnologists - Online Training Recording
Course No. 21475
Speakers
Dr. Marcus Fido
Mfi Bio-Consulting
Dr Sabine Hauck
dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Dr. Paul Stockbridge
Stockbridge Biopharm Consulting
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.
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.
Target Group
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.
Programme
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
This course is part of the GMP Certification Programme "ECA Certified Biotech Manager" Learn more
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