Course Overview

Biotechnology is transforming industries ranging from healthcare and agriculture to energy and environmental sustainability. As biotechnology continues to influence business strategies, product development, and regulatory frameworks, professionals across various sectors need a clear understanding of its principles, applications, and impact.

The Biotechnology for the Non-Biotechnologist programme by TransforMentors Academy is designed to provide a practical and accessible introduction to biotechnology for professionals without a scientific background. The course explores key concepts in molecular biology, biopharmaceutical development, manufacturing processes, regulatory requirements, and intellectual property management.

Through industry-focused examples and real-world applications, participants will gain the knowledge and confidence to communicate effectively with biotechnology professionals, understand emerging innovations, and make informed decisions within an increasingly biotechnology-driven landscape.

Agenda

Day — 1 Introduction to Biotechnology

• Fundamentals of Biotechnology and Its Historical Development
• Types of Biotechnology Products and Their Impact on Society
• Biotechnology Product Development Lifecycle
• Core Concepts in Molecular Biology:
  • DNA
  • RNA
  • Genes
  • Plasmids
  • Vectors
  • Protein Synthesis
• Principles of Protein Expression and Recombinant DNA Technology
• Development of Production Organisms:
  • Transfection
  • Selection
  • Preservation

Day — 2 Fermentation Technology and Large-Scale Production

• Fundamentals of Fermentation and Fermentation Processes
• Types of Fermentation and Their Industrial Applications
• Process Development Stages and Modes of Operation
• Process Optimisation and Scale-Up Strategies:
  • Strain Improvement
  • Media Optimisation
  • Process Enhancement
• Analysis and Evaluation of Biopharmaceutical Products
• Biotechnology Product Recovery and Purification Techniques

Day — 3 Formulation Design of Biopharmaceuticals

• Factors Influencing Biopharmaceutical Stability and Degradation
• Selection and Evaluation of Pharmaceutical Excipients
• Strategies for Enhancing Product Stability and Shelf Life
• Fundamentals of Drug Development and Bioprocess Economics
• Bioprocess Economics and Cost Optimisation Strategies
• Regulatory Considerations for Biopharmaceutical Products

Day — 4 Patenting Biotech Inventions

• Fundamentals of Patents and Patentability Requirements for Biotechnology Innovations
• Types of Biotechnology Products and Inventions Eligible for Patent Protection
• Drafting Patent Claims for Biotechnology Inventions
• Patent Examination and Approval Processes
• Strategies for Protecting and Enforcing Biotechnology Patents

Day — 5 Application of Regulatory Principles

• Regulatory Principles for the Development, Approval, and Commercialisation of Biotechnology Products
• Major Regulatory Agencies and Their Roles:
  • FDA
  • EMA
  • Other International Regulatory Bodies
• Documentation and Record-Keeping Requirements for Product Compliance
• Assessing Manufacturing and Process Changes Affecting Product Quality
• Regulatory Requirements and Challenges for Biosimilars
• Regulatory Frameworks for Advanced Therapy Products:
  • Gene Therapy
  • Cell Therapy
  • Tissue-Engineered Products

Learning Outcomes

Upon successful completion of this course, participants will be able to:

• Understand the fundamental principles of biotechnology and its impact on industry and society
• Explain fermentation processes and techniques used to optimise and scale biopharmaceutical production
• Identify factors influencing biopharmaceutical formulation, including excipient selection and product stability
• Understand drug development processes and the economics of biopharmaceutical manufacturing
• Apply key concepts of bioprocess economics to support manufacturing and business decisions
• Interpret regulatory requirements governing biopharmaceutical products
• Identify opportunities for patent protection and understand intellectual property strategies in biotechnology
• Understand the processes for protecting, managing, and enforcing biotechnology patents
• Recognise the role of regulatory agencies in the development, approval, and commercialisation of biotech products
• Evaluate emerging regulatory developments, including biosimilars and advanced therapy products

Who Should Attend

This course is designed for professionals seeking a practical understanding of biotechnology and its commercial, regulatory, and strategic applications, including:

• Managers and Team Leaders in Healthcare, Life Sciences, and Biotechnology Organisations
• Compliance, Quality, and Regulatory Affairs Professionals
• Legal, Intellectual Property, and Patent Specialists
• Sales, Business Development, and Marketing Professionals in Pharma and Biotechnology
• Investors, Financial Analysts, and Market Research Professionals
• Project Managers Supporting Biotechnology Initiatives
• Professionals Working with Biotech Products, Services, or Technologies
• Non-Scientific Professionals Looking to Build Confidence in Biotechnology Concepts and Industry Trends