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Pharmaceutical Intellectual Property Biotech

Biotechnology for the Non-Biotechnologist

25-27 Apr 2018

Standard 1849 2589 2589
Excluding VAT @ 20.00%

Venue: Radisson Blu Hotel, Nice, France, Nice

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Course overview

Biotechnology for the Non-Biotechnologist, ideal for non-Scientists and Scientists needing to understand the basic theory, principles, techniques and potential of biotechnology.

Why you should attend

  • Gain an introduction to the fundamental principles of Biotechnology
  • Improve your understanding of the key techniques used by Biotechnologists
  • Understand the importance of meeting regulatory requirements and hear about the advances being made
  • Learn how to identify potential patents, and why and how they must be protected

Who should attend

  • Quality Assurance
  • Regulatory Affairs
  • Legal and IP
  • Business Development
  • Sales and Marketing
  • Engineering
  • Finance
  • Finance
  • Training
  • Administration
  • Management

Programme Day one

Introduction to Biotechnology

  • Historical perspective
  • Diversity of biotechnology products
  • Impact on society
  • Product development overview

Introduction to Molecular Biology

  • DNA, RNA, genes, plasmids, and vectors
  • Protein synthesis – transcription and translation

Re-Expression of Proteins

  • Recombinant DNA techniques
  • Monoclonal antibodies – from mouse to human
  • Transgenic animals and plants

Development of Production Organisms

  • Transfection
  • Selection
  • Preservation

Fermentation Technology and Large Scale Production

  • Types of fermenters
  • Fermentation basics
  • Modes of operation
  • Process development

General Discussion

End of Day One and Drinks Reception

Programme Day two

  • Process Optimisation and Scale-Up
    • Scale-up strategies
    • Strain improvement
    • Media improvement
    • Process improvement
  • Analysis of Biopharmaceuticals
    • Biological activity
    • Physicochemical characterisation
    • Purity, impurities and contaminants
  • Product Recovery and Purification
    • Cell harvesting and removal
    • Clarification – intracellular and extracellular proteins
    • Chromatographic techniques
  • Formulation Design of Biopharmaceuticals
    • Factors affecting degradation
    • Choice of excipients
    • Prolonging shelf life
  • Process Economics
    • Drug development and bioprocess economics
    • Optimising bioprocess economics
    • Manufacturing make or buy
    • Future manufacturing alternatives
  • General Discussion

Programme Day three

Patenting Biotech Inventions

  • What is a patent?
  • What are the basic criteria for patentability?
  • What can be patented?
  • Can you patent genes, proteins, hybridomas, and stem cells?

Patent Workshop

  • How to recognise what is patentable
  • Drafting claims to biotech inventions
  • Maximising protection for an invention
  • Understanding the examination process
  • Enforcing patents

Regulatory Considerations of Biopharmaceuticals

  • General principles
  • Product quality and control
  • Pre-clinical safety

Application of Regulatory Principles

  • What do regulators want?
  • Specifications
  • Product characterisation
  • Assessment of process change
  • Comparability guidance and strategy

Advances in Regulation: Biosimilars

  • Comparability, equivalence and biosimilarity
  • Biosimilars guidance
  • Guidance vs Practice – a case study

Advances in Regulation: Advanced Therapies

  • Gene Therapy
  • Cell Therapy
  • Tissue Engineered Products

General Discussion

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Previous customers include...

  • Alfred E Tiefenbacher GmbH & Co KG
  • Amgen GmbH
  • Avecia Biotechnology Ltd
  • Bayer SAS
  • Bio Farma
  • Boehringer Ingelheim Animal Health GmbH
  • Centocor BV
  • Claire Gregg
  • Eisai Limited
  • Ferring Pharmaceuticals A/S
  • Galderma International
  • GlaxoSmithKline
  • IMS Health UK
  • LFB
  • Merck Serono SpA
  • Merck SL
  • Mitsubishi Tanabe Pharma Europe Ltd
  • NDA Regulatory Science Ltd
  • NNE A/S
  • Novbartis - Centre de Biotechnologie
  • Reckitt Benckiser Pharmaceuticals Inc
  • Rosenow Grob Schilling
  • Sanofi Chimie
  • Sanofi-Aventis R&D
  • Saudi Food and Drug Authority

What previous delegates say...

I really enjoyed this course, it was detailed and interesting. Speakers were very well qualified and good presenters

Jill Challis, Principal Consultant, NDA Regulatory Science Ltd

Very good. Broad overview. Friendly audience

Jean-Paul Chappuis, , Galderma International

Very positive opinion - content very clear - interaction with speakers was fruitful - Good to have each day a summary of what was learnt the day before

Vanessa Brousset, Manager Europe, Galderma R&D