INTRODUCTION
Biotechnology, the use of biology to solve problems and make useful products. The most prominent area of biotechnology is the production of therapeutic proteins and other drugs through genetic engineering.
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.
Biotechnology for the Non-Biotechnologist training 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.
OBJECTIVES
Delegates attending Biotechnology for the Non-Biotechnologist training course, will learn how to:
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 ?
Biotechnology for the Non-Biotechnologist course is ideal for:
Non-scientists and scientists needing to understand the basic theory, principles, techniques and potential of biotechnology.
COURSE OUTLINE
Day 1
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
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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
Day 3
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?
Day 4
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
Day 5
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
IN-HOUSE TRAINING
LPC Training is capable of conducting this training programme exclusively for your delegates.
Please e-mail us on admin@lpcentre.com for further information and/or to receive a comprehensive proposal.
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DOCUMENTATION
High-Quality material has been prepared by the LPC team for distribution to delegates.
CERTIFICATES
Accredited Certificate of completion will be issued to those who attend & successfully complete the programme.
SCHEDULE
Our Course timings commence at 09:00AM12:45PM Or 01:00PM - 05:00PM.
REGISTRATION & PAYMENT
Please complete the registration form on the course page & return it to us indicating your preferred mode of payment. For Further Information, please get in touch with us.
CANCELLATION AND REFUND POLICY
Delegates have 14 days from the date of booking to cancel and receive a full refund or transfer to another date free of charge. If less than 14 days notice is given then we will be unable to refund or cancel the booking unless on medical grounds. For more details about the Cancellation and Refund policy, please visit www.lpcentre.com/terms-and-conditions/
TRAVEL AND TRANSPORT
We are committed to picking up and dropping off the participants from the airport to the hotel and back.
CONTACT INFO
LONDON
Oxford Street, 25 N Row, London W1K 6DJ
+44 20 36 916 970 | +44 20 80 900 464 info@lpcentre.com
DUBAI
Business Bay, ParkLane Tower, Offices 718 - 719
+971 43 88 00 94
dubai.training@lpcentre.com
KUALA LUMPUR
No. 3273 Level 32, Menara Prestige, 1, Jalan Pinang, 50450 Kuala Lumpur +60 19 305 5694
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