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.

25-27 Sep 2019

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

Book now

Course overview

This intensive three-day course is ideal for non-scientists and scientists needing to understand the basic theory, principles, techniques and potential of biotechnology.

You will gain an overview of how biotech products are being developed and manufactured, and discuss the scientific and regulatory environment. The latest advances in regulation will be covered, including biosimilars and advanced therapies. The course will also discuss the role and importance of patents within biotech, including what actually can be patented.

Benefits of attending:

  • Gain an introduction to the fundamental principles of biotechnology
  • Improve your understanding of the key techniques used by biotechnologists
  • Understand tthe key regulatory considerations for biopharmaceuticals
  • Discuss advances in regulation – biosimilars and advanced therapies
  • Learn how to identify potential patents, and why and how they must be protected

Who should attend?

The course has been designed for those working in:

  • Quality assurance
  • Regulatory affairs
  • Legal and IP
  • Business development
  • Sales and marketing
  • Engineering
  • Finance
  • Clinical
  • Training
  • Project 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

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 iscussion

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

Book now

25-27 Sep 2019
25-27 Sep 2019 Cavendish Hotel, London GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • 42 Technology Ltd
  • ALEXION Europe SAS
  • Alvogen Malta Operations ROW
  • Bayer AG
  • Boehringer Ingelheim
  • Chiesi Farmaceutici SPA
  • Elcam Medical Ltd
  • ESTEVE
  • EuropaBio
  • F. Hoffmann-La Roche
  • Ferring Controlled Therapeutics Ltd
  • FUJISAWA GmbH
  • Galderma
  • Genmab BV
  • Genzyme Europe BV
  • Gregory Fryer Associates
  • Ipsen Pharma SAS
  • Jusmedico Law Firm
  • Kinesis Pharma B.V.
  • Kolster OY AB
  • Leo Animal Health As
  • Merck Sharp & Dohme
  • Novartis Vaccines & Diagnostics AG
  • Pfizer Global Research & Development
  • Real Regulatory Ltd
  • Sartorius Stedim Biotech GmbH
  • Shire
  • Syngenta Crop Protection Munchwilen AG
  • Turgut Ilac AS
  • Veterinary Medicines Directorate

The course is prepared to explain biotechnology in a very clear and complete way. It is intensive and you have to be focused to follow, but it's definitely worth the effort!

Roza Puzio, European Projects Manager, Atlanpole

Highly qualified speakers

Merecedes Rodríguez Rojas, Business Manager, CZ Veterinaria, S.A

Interesting, dense, good quality speakers.

Anna Sarao, Regulatory Affairs Project Manager, Servier

Very good. Lot's of content. Thank you!

Falk Neukirch, CFO, Vita 34 AG

All speakers were excellent and explained complex ideas very well. Fantastic, applicable course, presented really well. Great refresher course on Molecular biology.

Luisa Teixeira, Account Manager, Owen Mumford Ltd

Good selection. Good mix. This was useful for me.

Oliver Dale, Senior Specialist, MSD

Very good course, a bit condensed, very good speakers

Erik Andersen, Associate Director, Ferring Pharmaceuticals A/S

Very good

Rabiea Abdullah, Senior Regulatory Specialist, MSD

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.

Speakers - well experienced. Content - well structured presentations

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

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

Very good. Broad overview. Friendly audience

Jean-Paul Chappuis, , Galderma International

Course covers biopharmaceutical aspects of biotechnology thoroughly. Good presenters

Patrick John Couzens, Patent Attorney, Nestle Research Centre

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

Sarah Norton, Senior Scientific Officer, Veterinary Medicines Directorate

Very well organised

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

Course was very well outlined, prepared and presented

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

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

David Cooke, Analytical Science Team Leader, Pfizer Ltd

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

Good, useful, complicated

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

I liked the course and would recommend this to work colleagues

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