Author: Hermann Mucke, PhD
Executive Summary
Chapter 1
INTRODUCTION
1.1. From Esoteric Basic Science to the Bioengineered Protein Drug
Structure as the Key to Protein Form and Function
Antibodies: Immune Proteins Naturally Designed For Combinatorial Diversity
1.2. Leaving the Hype Cycle Legacy Behind
Why the Markets Overestimated Biotech in the 1980s
Biologicals as the Fastest-Growing Pharma Market Segment
Chapter 2
PERSPECTIVES AND CHALLENGES IN BIOLOGICS DISCOVERY AND DESIGN
2.1. Types of Protein Drugs
Hormones, Cytokines, and Enzymes
Antibodies and Their Fab Fragments
2.2. Characterizing Targets with “Protein Druggability”
Affinity vs. Avidity
2.3. The Technologies
Display Technologies: Phages and Yeast
2.4. Engineering “Developability” Into Therapeutic Proteins
Combinatorial Mutagenesis and Directed Evolution
Rational Design: Bioinformatics and Modeling For In Silico Immunology
Synthetic Gene Design and Optimization
Modifying Glycosylation and Other Critical Post-Translational Modifications
2.5. Antibody Derivatives and Biobetters
Toolboxes for Immunoglobulin Design and Engineering
2.6. New Developments in Display Technologies and Screening Strategies
The Changing Concept of the “Antibody Library”
New Developments in Display Technologies
Antibody Selection and Optimization beyond Cell Display Technologies
Chapter 3
BUSINESS WITH PROTEIN ENGINEERING
3.1. The Protein Engineering Company: A Breed of its Own
3.2. Development and Financing Profiles for Protein Drugs
The Lengthening Timeline
Risk and Capital Investment
Product Pricing and Competition by Small-Molecule Drugs: Pharmacoeconomics is Key
Engineering Proteins to Marketing Strategy
Patenting Strategies for Engineered Proteins
Protein Engineering to Avoid Manufacturing Issues
3.3. The Biosimilars Are Coming—the Biobetters Will Follow
The Distinctive Complexity of Biologicals
Comparables, Not Generics: Strategic Dilemma and Potential
The FDA’s Long and Unfinished Way to Biosimilars
Biosimilar Introduction and Market Penetration: Will Europe and Asia Set a Pattern for the United States?
Targets for Biosimilars and Companies Developing Them
3.4. Biobetters: Engineering beyond Biosimilars
Chapter 4
PERSPECTIVES FOR PROTEIN ENGINEERING
4.1. Recent Patenting Reveals Current Earliest-Stage R&D Patterns
4.2. The Evolution of the Protein Engineering Tools
In Silico Immunology and Immunological Bioinformatics
Synthetic Biology
Protein Characterization Tools: The “Orthogonal Approach”
4.3. Alternative Expression Systems
Beyond Today’s Bioreactors: Plants and Insects
Unconventional Microbial Expression Systems
Human Cell Lines
4.4. Biotech Drugs for “Undruggable” Pathways: A Realistic Option?
4.5. Engineering Proteins for Delivery Devices
4.6. Evolution of Regulatory Guidelines and Practices
4.7. Perspectives for Financing: Market-Tailored Strategies Are Needed
Have an Eye on the Regions: Protein Engineering is Globalizing
Chapter 5
COMPANIES IN THE PROTEIN ENGINEERING BUSINESS
5.1. Examples of Developer Companies in the Protein Engineering Business
4-Antibody AG
Abbott Bioresearch Center, Inc.
Ablynx NV
Adimab, Inc.
Affimed Therapeutics AG
Affitech A/S
Alexion Pharmaceuticals, Inc.
Amunix, Inc.
Apeiron Biologics AG
Apexigen, Inc.
Applied Integrin Science, Inc.
Avipep Pty Ltd.
BioInvent International AB
Biogen Idec
Biotecnol SA
BioTransformations Ltd.
Complix NV
Corimmun GmbH
Covagen AG
Crescendo Biologics Ltd.
Dyax Corp.
Emergent BioSolutions, Inc.
Fabrus LLC
f-star GmbH
Genmab A/S
Glythera Ltd.
ImmunGene, Inc.
ImmunoGen, Inc.
Immunomedics, Inc.
ioGenetics, LLC
Ixo Therapeutics Ltd.
Kymab Ltd.
MacroGenics, Inc.
MedImmune
Merus B.V.
Micromet, Inc.
Molecular Templates, Inc.
MorphoSys AG
NovImmune SA
Pieris AG
Perseid Therapeutics, LLC
PharmAbcine
Roche Glycart AG
Seattle Genetics, Inc.
SpectraMab GmbH
Sutro Biopharma, Inc.
Trion Pharma AG
Trellis BioScience
Viventia Biotechnologies, Inc.
X-BODY Biosciences
Xencor, Inc.
XOMA (US), LLC
Zyngenia, Inc.
5.2. The “Toolbox” Companies: Technology Vendors for Protein Engineering
Accelrys, Inc.
Attana AB
Bioceros B.V.
DNA2.0, Inc.
Novozymes Biopharma US, Inc.
Selexis, Inc.
Zymeworks, Inc.
References
Company Index with Web Addresses