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The Biotech Primer: An insider’s guide to the science driving the biotech & pharma industries is a 200-page book featuring illustrations and a glossary of biotechnology terms. The text takes an in-depth look at the biotech industry, and in particular, the science that drives it. From cell structure to protein structure; gene expression to genetic variation and genetic engineering; the human immune response to the production of antibodies for biotech application; and finally drug discovery, drug development, and biomanufacturing – we discuss the key concepts and technologies that impact current biotechnology developments.

This book will support your growth as a biotechnology professional. Although the industry itself is constantly changing, these fundamental concepts upon which it is built will remain important for years to come – and decision-makers who understand these fundamentals will be better able to evaluate and predict new trends.

More than anything else, we hope that your understanding of the science behind biotechnology will serve to increase your enthusiasm for this exciting and truly life-changing industry. The future is here – be a part of it.

The Biotech Primer Table of Contents

Chapter 1: What The Heck Is Biotech?   1
Healthcare Sector
Agricultural Sector
Industrial and Environmental Sector
Company Close‑Up
Related Companies
Academic, Government, and Non‑Profit Research

Chapter 2: Putting The BIO In Biotech    21
Cells: The Basic Unit of Life
Cell Structures
But What Do Cells DO?
Cells Communicate
Cells Grow and Divide
Cells Manufacture Proteins
Cell Signaling: A Closer Look
Growth Factor Signaling
G Protein Coupled Receptor Signaling
Ligand Activated Ion Channels
Signaling Network Complexity

Chapter 3: Life’s Blueprint   41
History of DNA
Life’s Building Blocks
Putting the Building Blocks Together
How DNA Replicates
Organization of DNA
The Human Genome Project

Chapter 4: From Gene To Protein   55
Proteins Take Shape
Protein Shape and Sickle Cell Disease
Protein Levels and Cancer
RNA Interference

Chapter 5: Mutations: The Spice Of Life    71
Single Nucleotide Polymorphism
Genetic Basis of Disease
Polygenic Disease: Cancer
Monogenic Disease: Sickle Cell Anemia
International HapMap Project
Pharmacogenomics
Personalized Medicine in Practice

Chapter 6: The Technology That Created An Industry   89
Transgenic Organisms
Uses of Transgenic Organisms
Recombinant DNA
Engineering Bacteria
Engineering Mammalian Cells
Recombinant Proteins in Healthcare
Pharm Animals
Disease Models
Gene Therapy

Chapter 7: Immune Response: Defender Extraordinaire    109
Immune System Cells
Non-Specific Immune Response
Specific Immune Response
T‑Cells
B‑Cells
Antibodies
Biotech Applications of Antibodies
Humanizing Mouse Antibodies

Chapter 8: The Science Of Discovery   127
A Brief History
Identifying the Target
Types of Targets
Validating the Target
Theraputic Choices: Small Molecule Versus Large
Molecule Drugs
Assay Development
High Throughput Screening
From Hit to Lead
Biomarkers

Chapter 9: Lab To Marketplace    147
The Drug Development Process
Regulatory Agencies
Preclinical Development
Clinical Trials
Patents
Generic: Small Molecule
Biosimilar: Large Molecule.

Chapter 10: Putting The BIO In Biomanufacturing   161
Biomanufacturing Process Overview
Critical Steps in a Production Campaign
Cell Banks
Scale‑Up and Manufacturing Process
Harvesting and Purification Process
Column Chromatography
Ion Exchange Chromatography
Affinity Chromatography
Size Exclusion Chromatography
Formulation, Fill, and Finish

Conclusion   173
Glossary   175