Biotechnology for the Non-Biotechnologist

Course Info

Date: July-04-2022

Length: 1 Week

City: Istanbul

Fees: 3,900

Type: In Classroom

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  • Aug-29-2022

    Istanbul

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  • July-18-2023

    Madrid

  • July-25-2023

    London

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    Singapore

  • Aug-08-2023

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    Zurich

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    Amsterdam

Course Details

Course Outline

5 days course

 

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

 

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

 

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

Course Video