Biotechnology for the Non-Biotechnologist (Nice, France - April 25-27, 2018)

  • ID: 4435672
  • Conference
  • Location: Nice, France
  • 3 Days
  • Management Forum
  • Conference Dates: April 25-27, 2018
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Biotechnology for the Non Biotechnologist, ideal for non-Scientists and Scientists who need to understand the basic theory, principles, techniques, and potential of biotechnology

Course overview

Join this extensive three-day training course to gain a thorough understanding of the fundamental principles of Biotechnology to deepen your knowledge of the key techniques used by Bio-technologists. It will show you the importance of meeting regulatory requirements along with the advances being made. You will also learn how to identify potential patents, as well as why and how they must be protected.

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

Radisson Blu Hotel
223 Promenade des Anglais
Nice
06200
France

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