Three Day Biotechnology for the Non-Biotechnologist Course (London, United Kingdom – September 25-27, 2019) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Biotechnology
for the Non-Biotechnologist” conference has been added to ResearchAndMarkets.com’s
offering.

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

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 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:

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

Agenda:

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

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

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

For more information about this conference visit https://www.researchandmarkets.com/r/cujq9w

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
[email protected]
For
E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related
Topics: Biotechnology