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Reportlinker Adds Enzymes in Drug Manufacturing

NEW YORK, April 4, 2011 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

Enzymes in Drug Manufacturing

Biocatalysis in pharmaceutical manufacturing is being driven by advances in enzyme and genomics technologies that are increasing the breadth of reaction applicability. The environmental benefits of enzymatic catalysis are also a strong influence.

This report examines the benefits and challenges of implementing enzymatic steps in pharmaceutical manufacturing. It covers why enzymes are central to green chemistry and industrial biotechnology. The range of industrial enzymes and sources of innovation are covered, along with numerous case studies of enzymes being successfully employed.

Scope of this research

- Understand why biocatalysis plays a central role in the emerging trend toward green chemistry.

- Appreciate the power of enzymes in controlling the formation of chiral products.

- Learn of the techniques employed to develop non-natural enzymes that are better suited to industrial processes.

- Examine case studies in which enzymes have provided significant benefits during process development and optimization efforts. Identify the likely sources of future advances in developing novel enzymatic catalysis processes.

Research and analysis highlights

Enzymes can replace conventional catalysts in drug manufacturing and give significant gains in terms of reduced raw materials and other inputs by improving efficiency and allowing reactions to take place under milder conditions. Biocatalytic steps often offer a powerful solution to the problem of controlling stereochemistry.

Both green chemistry and industrial biotechnology are important emerging trends worldwide. Enzymes are central to both disciplines so developments are likely to increase the focus on biocatalysis and encourage its wider implementation within industry.

There are many potential sources of innovative enzymes that could meet the needs of pharma. These include organisms from extreme environments and genomic databases. New and old enzymes can be optimized for their properties using technologies such as directed evolution.

Key reasons to purchase this research

- What benefits do enzymes offer compared with conventional chemical synthesis?

- How can an enzymatic steps be integrated into an existing manufacturing process and what are the challenges in so doing?

- Why are enzymes such a key focus in both green chemistry and industrial biotechnology?

- How can a natural enzyme be modified so that its properties are compatible with process conditions typically found in the pharmaceutical industry?

- What sectors of industry currently make the best use of enzymes in their processes and can pharma follow suit?

Table of Contents

About the author 2

Disclaimer 2

Executive summary 11

Introduction 11

Industrial biotechnology 11

Green chemistry in drug manufacturing 12

Enzymes and the enzyme industry 13

Overview of the use of enzymes in drug manufacturing 13

Case histories of biocatalysis 14

Industrial enzymes from extremophiles 15

The way forward 16

Enzyme companies and their products 17

Chapter 1 Introduction 18

Summary 18

Introduction 18

Technical advantages of biocatalysis 21

Expanding the enzyme toolkit 23

Genome and metagenome databases 23

Enzyme engineering and directed evolution 24

Host expression technology 24

Pathway engineering 25

Synthetic biology 25

Regulatory changes favoring biocatalysis 25

Introduction to stereochemistry 26

Structural isomerism 27

Stereoisomerism 28

Cis-trans isomerism 28

Enantiomerism 29

Diastereoisomerism 30

Important functional groups in medicinal chemistry/drug manufacturing 32

The history of the use of enzymes in drug manufacturing 33

Chapter 2 Industrial Biotechnology 34

Summary 34

Introduction 34

Defining industrial biotechnology 35

Enzymes 36

A growing market 37

Government initiatives 38

The US and IB 39

Europe and IB 40

IB – the future 43

Norway – from blue to white biotech 44

Focus on Russia 45

Chapter 3 Green chemistry in drug manufacturing 47

Summary 47

Introduction 47

The growth of green chemistry 48

Enzymes and the rules of green chemistry 49

Green chemistry and big pharma 50

Green chemistry and catalysts 51

Green chemistry infrastructure 53

CoEBio3 53

The Green Chemistry Centre for Industry 55

Drivers and barriers to widespread adoption of green chemistry 55

Patent protection 56

Environmental regulation 57

Education 57

Presidential Green Challenge 57

Green chemistry and vitamin C synthesis 58

Chapter 4 Enzymes and the enzyme industry 60

Summary 60

Introduction 60

The enzyme tool kit 62

Metagenomics 64

Sequence-based discovery 65

Improving on nature's enzymes for industry 65

Rational enzyme design 66

Directed evolution 66

Case study – Lipitor 67

Chapter 5 Overview of the use of enzymes in drug manufacturing 69

Summary 69

Introduction 70

Implementing biocatalysis in drug manufacturing 70

Using enzymatic resolution 73

Enzymes with a track record in the chemical pharmaceutical industry 74

Lipases 75

Oxidoreductases 76

Nitrilases 78

Epoxide hydrolases 78

Hydroxynitrile lyases 78

Aldolases, glycosidases, and glycosyltransferases 79

Amidases 80

The synthesis of chiral amines 80

A comparison of chemical and biocatalysis routes 81

Chapter 6 Case histories of biocatalysis 82

Summary 82

Introduction 83

Specific case studies 83

Pregabalin 83

Aliskiren 84

Posaconazole 85

Ribavirin 86

Beta-lactam antibiotics 87

Biocatalysis in GW's antiviral program 88

Lamivudine 88

Zanamavir 89

Indinavir 91

Aprepitant 92

Paroxetine 92

Levetiracetam 92

Examples of whole-cell biotransformations in drug manufacturing 92

Chapter 7 Industrial enzymes from extremophiles 96

Summary 96

Extremophiles – a largely unexplored resource for industry 97

Case history of a potential industrial enzyme 100

Examples of extremozymes for the pharmaceutical industry 100

The future of extremophile research and its applications 104

Chapter 8 The way forward 106

Summary 106

Introduction 107

Reducing waste 108

A whole-industry approach 108

Making more enzyme tools available 109

Enzymes for pharma – a growing market? 110

Chapter 9 Enzyme companies and their products 112

Summary 112

Introduction 113

Aquapharm Biodiscovery (Oban, UK) 114

ArcticZymes AS (Tromso, Norway) 115

Codexis (Redwood City, CA) 115

DSM Pharmaceutical Products (Parsippany, NJ) 116

Dyadic International Inc (Jupiter, FA) 117

Genecor (Copenhagen, Denmark) 117

Novozymes (Bagsvaerd, Denmark) 118

Specialty Enzymes and Biotechnologies (Chino, CA) 119

ZyGEM Corporation (Hamilton, New Zealand) 119

Appendix 120

Scope 120

Methodology 120

Primary research 120

Secondary research 120

Glossary/Abbreviations 121

References 122

Other sources 127

Table of figures

Figure 1: Illustration of structural isomerism 28

Figure 2: Illustration of cis-trans isomerism 29

Figure 3: Illustration of enantiomerism 29

Figure 4: Illustration of diastereoisomerism 31

Figure 5: Main principles of green chemistry 49

Figure 6: Green chemistry drivers and barriers 56

Figure 7: Synthetic biocatalytic route to vitamin C 58

Figure 8: BASF process for producing chirally pure amines 75

Figure 9: Enzymatic resolution using an esterase en route to aliskiren 85

Figure 10: Enzymatic resolution of a racemic alcohol using a lipase 87

Figure 11: Enzymatic steps in the production of zanamavir 91

Figure 12: Challenges and opportunities for extremophiles 105

Table of tables

Table 1: Top 20 pharmaceutical products in the market by sales ($bn), 2009 21

Table 2: Chemical sales by segment, 2007–2012 38

Table 3: White biotech industry growth, 2007–2012 38

Table 4: US biobased chemicals penetration of global market (%), 2010–2025 39

Table 5: Enzymes used in drug manufacturing 73

Table 6: Enzymes often used in resolution processes 74

Table 7: Commercial drugs using biotransformation processes 95

Table 8: Categories of extremophiles 98

Table 9: Examples of extremozymes 104

Table 10: Revenues of leading enzyme companies 114

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Enzymes in Drug Manufacturing

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Nicolas Bombourg
US: +1-805-652-2626
Intl: +1-805-652-2626

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