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5-6 October 2017

Speakers


Dr Markus Fido, VelaLabs, Austria

Arjan Langen, MSD, The Netherlands

Dr Paul Stockbridge, Stockbridge Biopharm Consulting, United Kingdom



Learning Objectives


This course 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 Course is addressed to those interested in pharmaceutical biotechnology related to GMP manufacturing and marketing authorisation.

Programme


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
GMP Guidelines in Biotechnology
  • European Guidelines
  • FDA Guidelines
  • ICH
  • ISPE
  • PIC/S
  • PDA
  • WHO
  • APIC
  • ISO
Manufacturing of biotechnological API – Focus on 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
Manufacturing of Biotechnological API – Focus on 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
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
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
  • From initial cell to product
  • Manufacturing
  • Storage
  • Quality Control
  • Release Documentation
Virus Reduction
  • Regulatory background
  • Relevant and model viruses
  • Common and new methods of virus reduction
  • TSE Safety
Fill and Finishing
  • Aseptic processing and media fill
  • Liquid formulation or lyophilisation?
  • Stability tests of Biopharmaceuticals