Live Online Training: Pharmaceutical Biotechnology for Non-Biotechnologists

Live Online Training: Pharmaceutical Biotechnology for Non-Biotechnologists

Seminar Nr. 18425

All times mentioned are CET.

Kosten

ECA-Member: EUR 1590,--
Non ECA Member: EUR 1790,--
EU/GMP Inspectorates: EUR 895,--
APIC Member Discount: EUR 1690,--

Alle Preise zzgl. MwSt.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Markus Fido, MFI Bioconsulting, Austria
Dr Sabine Hauck, Leukocare, Germany
Dr Paul Stockbridge, Stockbridge Biopharm Consulting, UK

Zielsetzung

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. 

Hintergrund

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.

Zielgruppe

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.

Programm

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

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