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Biotechnology for the Non-Biotechnologist Training Course

An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

1-3 Dec 2021

& 7-9 Mar 2022 , 27-29 Jun 2022 , 28-30 Sep 2022

Book now

Details

Course overview

The importance of the biotech industry has increased significantly over recent years and biotech companies now dominate the new drug pipeline. The industry is gaining momentum and advancements in biomedical science and increased innovation hold vast potential for the growth of the biotech market.

This intensive three-day course will provide an overview of how biotech products are being developed and manufactured, and discuss the scientific and regulatory environment. The interactive programme will cover the latest advances in regulation, including biosimilars and advanced therapies, and address 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 the 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?

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

It will be relevant for anyone needing either an overview or refresher, particularly those working in:

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

Programme

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

Analysis of biopharmaceuticals

  • Biological activity
  • Physicochemical characterisation
  • Purity, impurities and contaminants

Formulation design of biopharmaceuticals

  • Factors affecting degradation
  • Choice of excipients
  • Prolonging shelf life

Product recovery and purification

  • Cell harvesting and removal
  • Clarification – intracellular and extracellular proteins
  • Chromatographic techniques

Process optimisation and scale-up

  • Scale-up strategies
  • Strain improvement
  • Media improvement
  • Process improvement

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

Presenters

Adekunle Onadipe (More...)

Dr Adekunle Onadipe is an Associate Research Fellow in Bioprocess R&D, Cell Line Development at Pfizer Inc. USA. He leads a group of scientists responsible for the construction, development and characterization of mammalian and microbial cell lines for biotherapeutics and vaccines production. His group is also involved in the scale-up of bioprocesses from bench top to pilot scale bioreactors and process development for the establishment of cell banks to support the manufacture of biopharmaceutical products for early phase clinical trials.

Kunle joined Pfizer Limited in the UK in 2005 in Discovery Biology with responsibility for optimizing cell culture processes for the production of cell-based assay reagents. Prior to this he worked for 15 years at Lonza Biologics plc., in Slough UK where, as a Principal Group Leader in cell culture process development, he was responsible for constructing and developing production mammalian cell lines and culture processes, subsequently transferring them to full-scale production for clinical trials.

A microbiologist by training, Kunle has been involved in the production of biopharmaceuticals for more than 30 years and has a broad experience of microbial and mammalian cell culture methods. He obtained his PhD in Microbiology from the University of Surrey, Guildford UK.

Adrian Haines (More...)

Dr Adrian Haines is the Head of Science and Technology at Sobi AG, based in Geneva, Switzerland. Adrian has extensive experience in generating mammalian cell lines suitable for the GMP production of biologics and is extensively involved in the scientific oversight of both upstream and downstream process development, and process characteristion studies prior to regulatory filings. He joined the company (then 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 ~30 years, starting with his PhD where he generated monoclonal antibodies (using hybridoma technology) for the diagnosis of prostate cancer. He received a bachelor degree from Imperial College, London, and a PhD from St Thomas’ Hospital Medical School, University of London.

Peter O'Callaghan (More...)

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 Principle Scientist where he is responsible for the development and commercial implementation of new gene expression technologies, cell lines, and tools for recombinant therapeutic protein production using CHO cell lines. He also leads R&D strategies for developing next-generation technologies and processes, in addition to supporting commercial launch and associated promotional work

Kate Smith (More...)

Kate Smith is currently Principal Scientist, Development Services, at BioReliance, UK, part of the Merck Group. In this position she is reponsible for providing technical supprt to both colleagues adn clients on the deign, execution and interpretation of viral clearance studies. Prior to transitioning into Development services Kate was responsible for managing the team involved in the preparatino of cell banks, viral seeds stocks and production of clinical lots of virus. .
Prior to joining BioReliance Kate was a Principal Group Leader in the Purification Development Group at Lonza Biologics, plc. She has more than 18 years experience in the development, scale-up, transfer and validation of purification processes for monoclonal antibodies and recombinant proteins from mammalian cell cultures. Her area of expertise is the design and management of Viral and DNA reduction studies used to support product safety.

Alison Sykes (More...)

Alison Sykes is Director Physico-Chem Analytics, for Fresenius-Kabi, SwissBio Sim, a post she took up in 2017. She was formerly a Director within the Biosimilar Unit of Merch Serono and Biosimilar Technical Director within Analytical Services at Lonza Biologics plc responsible for oversight and definition of all analytical activities relating to pre-clinical and clinical development of Biosimilars derived from mammalian and microbial cell culture. She had worked for Lonza for 25 years, responsible for running various different analytical teams and functions including cell culture support, method development and validation, stability and formulation and protein characterisation. She has been responsible for set-up and establishing FDA and MHRA approved laboratories and providing technical and advisory support for CMC development of biopharmaceuticals from pre-clinical through to clinical phases, including several successful BLA licence applications. A biochemist by training, she started her career working for the National Health Service and then moved to NIBSC. Her experience here on the human side of the drug industry and the need for global standards in protein drug development helped drive her enthusiasm for detailed analysis and characterisation of safe and efficacious biopharmaceuticals.

Philip Webber (More...)

Dr. Philip Webber obtained his first degree from Cambridge University, UK (Natural Sciences, Genetics) and then carried out research on the regulation of brain-specific genes at Warwick University, UK, where he obtained his PhD.
He qualified as a UK Chartered Patent Attorney and European Patent Attorney with Dehns (formerly Frank B. Dehn & Co.) London and Oxford, and is now a partner in their Life Sciences Group. He has a worldwide client-base including clients from the UK, Scandinavia, the US and Japan. Amongst other things, his work involves the preparation and filing of patent applications in Europe and throughout the world; acting for his clients in opposition procedures at the European Patent Office; and searching for and advising his clients on the relevance of competitors’ patents. He is an active member of the Life Sciences Committee of the UK Chartered Institute of Patent Attorneys (CIPA). He has spoken at a number of European conferences and on BBC Radio on the patenting of biotech inventions, as well as publishing a number of papers in this area.

Rhydian Howells (More...)

Rhydian Howells, associate director of regulatory affairs at Diamond Pharma services a Propharma group company. 20 years’ experience in the industry, 10 years at a large contract manufacturer developing manufacturing processes and analytical offerings for biological products followed by 10 years in regulatory CMC roles supporting clients with clinical development and marketing authorisation activities for large molecules and advanced therapies.

Book now

Book now

1-3 Dec 2021
Face-to-face, (venue not yet confirmed)
1-3 Dec 2021
Face-to-face
(venue not yet confirmed)
GBP 1,849 1,549
EUR 2,589 2,169
USD 2,884 2,416
Until 27 Oct*
Enrol now
Limited
places

to attend
Face-to-face
(venue not yet confirmed)
  • 3 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
7-9 Mar 2022
Live webinar
7-9 Mar 2022
Live webinar
GBP 1,549 1,249
EUR 2,229 1,809
USD 2,524 2,056
Until 31 Jan 22*
Enrol now
to attend
Live webinar
27-29 Jun 2022
Face-to-face, (venue not yet confirmed)
27-29 Jun 2022
Face-to-face
(venue not yet confirmed)
GBP 1,849 1,549
EUR 2,589 2,169
USD 2,884 2,416
Until 23 May 22*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 3 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
28-30 Sep 2022
Live webinar
28-30 Sep 2022
Live webinar
GBP 1,549 1,249
EUR 2,229 1,809
USD 2,524 2,056
Until 24 Aug 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

This course qualifies for 18 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Alizyme Plc
  • ALPHARMA AS
  • Amgen GmbH
  • APL
  • DSM Nutrional Products Ltd
  • Eisai Limited
  • F. Hoffman La Roche AG
  • Ferring Controlled Therapeutics Ltd
  • Galderma
  • GALDERMA R & D
  • Galderma R&D - Les Templiers
  • Germain & Maureau
  • GlaxoSmithKline
  • IMS Health UK
  • IQVIA
  • Kinesis Pharma BV
  • Klifovet A.G.
  • LEK Pharmaceuticals d.d.
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • MHRA
  • NOVO NORDISK AS
  • Pfizer Limited
  • Sanofi-aventis Groupe
  • Sekisui Diagnostics (UK) Ltd
  • Specialised Therapeutics Australia Pty Ltd
  • Stratagem IPM Limited
  • Theravance Biopharma
  • TNO QUALITY OF LIFE
  • University of Surrey
  • WDA INTERNATIONAL

The content was excellent and all presenters were clearly SMEs, who managed to explain much of the complex content in an understandable way.

Sunil Singh, Director, Regulink Ltd, Sep 21

The presentations were well prepared in general and I learned a lot.

Katja Pecjak, Director of Regulatory Affairs & QPPV, Billev farmacija vzhod d.o.o, Apr 21

Excellent. Really enjoyed and learned a lot.

Anthony Barker, Director - Regulatory CMC, Home Address, Apr 21

Really interesting, and a great introduction to someone with little/no knowledge of biotechnology. Also great that it went from scientific processes through to industrial processes. Nicely laid out. Well worth the three days!

Jackie Knipe, IP Paralegal, ALBUMEDIX LTD, Sep 20

I felt like the three days flowed together really well, first giving a basic understanding of the biology side of these products, how they are made and then their uses.

Laura Jones, Regulatory CMC Manager, AstraZeneca, Sep 20

I thought it was a really interesting overview of biotechnology, from the specific scientific processes all the way through to the industry trends. I appreciated the discussion of advantages/ disadvantages and challenges of various methods and the industry as a whole, as I think this added a lot of context. This was beneficial for me when I was trying to apply what I had learned in the day to my specific company's context.

Sian Gilfillan, Marketing and Communications Associate, Albumedix, Sep 19

The course was comprehensive and the speakers were both subject matter experts and very good presenters. I really enjoyed the three days.

Linnea Elrington, VP, Head of HR, Silence Therapeutics, Sep 19

A good general introduction that managed to make this very technical subject matter understandable to those with little scientific background, or as a refresher to those who may have graduated many years previously.

Matthew Jordan, Imerys Minerals , Sep 19

The content and presentation were very good.

Rutger Vandiest, Sr Director - Head of Sales, Bavarian Nordic, Apr 19

I really appreciated the course and learned a lot.

Natacha Gonzalez, CMC Dossier & Compliance Specialist, Merck, Apr 19

I wanted to learn the basics of biologicals research and establishment/characterization of MCB. I also wanted to learn more on biologics manufacture and registration/filing. All of this was accomplished.

Michael Vestling, Regulatory and Quality Manager, INTERVACC AB, Apr 19

Well-balanced set of topics – nothing of importance seems to have been left out. The perfect level of detail for me as a biotech program leader/manager with a non-biotech scientific background.

Sergio Freitas, Development Program Lead, Tillotts Pharma AG, Apr 19

Excellent course – I learned a lot despite having worked as an in-house lawyer for a CMO for almost 5 years. The speakers were highly competent, engaged, knowledgable and able to answer all of my questions (and I had quite a few). Overall, a course I can highly recommend to other in-house lawyers.

Anna Damgaard Jensen, Head of Legal , AOP Orphan Pharma, Sep 18

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, Sep 18

Interesting course with good quality speakers.

Anna Sarao, Regulatory Affairs Project Manager, Servier, Apr 18