Biotechnology for the Non-Biotechnologist

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

10-12 Apr 2019

GBP 1,849
EUR 2,589
USD 2,884

Book now

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

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

Presenters

Adrian Haines

Dr Adrian Haines is the Section Head of Process Development Sciences at Novimmune SA, Switzerland. He leads teams of upstream and downstream development scientists who work within a CMC environment to develop, evaluate and characterise processes for the production of monoclonal antibodies and novel κλ-bodies. He has extensive experience in generating mammalian cell lines suitable for the GMP production of biologics.
He joined Novimmune in 2015 and prior to this he worked at Lonza Biologics in the UK working on projects to develop new technologies and processes for generating manufacturing cell lines. Before that he worked for ML Laboratories/Cobra Research developing UCOE technologies for the expression of proteins in mammalian cells and at Therexsys Ltd, developing antibody targeted gene therapies. Prior to this he worked at Celltech Research Ltd, generating radiolabelling and cross-linking technologies for antibodies.
A biochemist by training, he has been involved in the protein chemistry and production of monoclonal antibodies for over 28 years starting with his PhD where he generated monoclonal antibodies (using hybridoma technology) for the diagnosis of prostate cancer. He received his bachelor degree from Imperial College, London, and his PhD from St Thomas’ Hospital Medical School, University of London.

Peter O'Callaghan

Peter O’Callaghan holds BSc and PhD degrees in Genetics from Newcastle University. Since graduation he has gained over 10 years’experience in biotechnology research and development in academia and industry, during which time he co-authored patents as well as research articles and reviews in international peer-reviewed scientific journals and books.
Since 2011 he has been woking in the New Expression Technologies group at Lonza Biologics in Cambridge. He works as an Associate Principle Scientist where he leads efforts to develop new technologies for the industrial synthesis of antibody-based biotherapeutics.

Book now

10-12 Apr 2019
10-12 Apr 2019 Radisson Blu Hotel, Nice, France, Nice GBP 1,849.00
EUR 2,589.00
USD 2,884.00
Enrol now

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Previous customers include...

  • AMGEN LTD
  • Boehringer Ingelheim Pharmaceuticals Inc
  • DIAGNOSTICA
  • Elanco
  • Elanco Animal Health
  • Gadea Grupo Farmaceutico
  • GILROY FILTRATION LTD
  • Helsinn Birex Pharmaceuticals Ltd
  • IHS Global Insight
  • Ipsen Biopharm Ltd
  • IQVIA
  • Kinesis Pharma B.V.
  • Kinesis Pharma BV
  • Laboratorios Leti SL
  • Leo Pharma A/S
  • Lonza Biologics PLC
  • Mitsubishi Tanabe Pharma Europe Ltd
  • MOSCOW MEDICAL ACADEMY
  • PANNONE & PARTNERS
  • Pfizer Global Research & Development
  • Pliva Croatia Ltd
  • QUINTILES SA
  • Science Union SA
  • Shire
  • Shire Pharmaceutical Ltd
  • Tanatex Chemicals BV
  • TEFEN EUROPE
  • TIllotts Pharma AG
  • Valeant Sp. z o.o. Sp. j.
  • Wyeth Pharmaceuticals

Exciting world of journey into the Bio molecules. Well structured training, clear presentations and explanations.

Oliver Jungmann, Global Head Drug Substance Technical Lead, F. Hoffmann-La Roche Ltd.

Very good

Rabiea Abdullah, Senior Regulatory Specialist, MSD

Very good course, a bit condensed, very good speakers

Erik Andersen, Associate Director, Ferring Pharmaceuticals A/S

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

Course covers biopharmaceutical aspects of biotechnology thoroughly. Good presenters

Patrick John Couzens, Patent Attorney, Nestle Research Centre

Very good. Broad overview. Friendly audience

Jean-Paul Chappuis, , Galderma International

Speakers - well experienced. Content - well structured presentations

Lina Cacic, Regulatory Affairs Advisor, Agency for Medicinal Products and Medical Devices of Croatia (HALMED)

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

Course was very well outlined, prepared and presented

Isaac Hanania, LL.M., Boehringer Ingelheim RCV GmbH & Co KG

Very well organised

Marjon van Dijk, Associate Consultant Chemistry, Manufacturing & Control, Kinesis Pharma B.V

An excellent course! Very informative both for beginners and as a refresher.

Sarah Norton, Senior Scientific Officer, Veterinary Medicines Directorate

Intense but very interesting course that takes you back to the basis of biotechnology and also provides some inside in regulations

An van Hemelrijck, RA Consultant, PhaRA

I liked the course and would recommend this to work colleagues

Anna Woźniak, , Valeant Sp. z o.o. Sp. j.

Very comprehensive and intense. Mostly interested in the science and processes, less interested in patents.

David Cooke, Analytical Science Team Leader, Pfizer Ltd

Good, useful, complicated

Nicolai Soberg-Hansen, Patent Administrator, Genmab A/S