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Table 2. Roadmap for Development of Technologies to Produce Proteins (acronyms)

Objectives and Subtopics

Research

Pilots

Production

Products

Protein Production

Small soluble proteins

Protocol refinement

Optimization for cost-effectiveness

Scale up to 2 k/yr

Protocol standards

QA standards

Scale up to 25k/yr

Multiple forms of proteins

Protein chips

Protocols

Protein Production

Membrane proteins

Detergents

Refolding

Novel expression systems

Cell-free expression

Chemical synthesis

Domain identification

Domain expression

Evaluate/validate expression systems

Protocol standards

QA standards

Automate

Scale up

Multiple forms of proteins

Protocols

Protein Production

Multiple domain proteins

Proteins with fusion tags

Refolding

Novel expression systems

Cell-free expression

Chemical synthesis

Domain identification

Domain expression

Evaluate/validate expression systems

Protocol standards

QA standards

Automate

Scale up

Multiple forms of proteins

Individual protein domains

Protein chips

Protocols

Protein Production

Multiprotein complexes (when needed for co-expression or stabilization and storage)

Binding-partner identification

Refolding

Novel expression systems

Cell-free expression

Evaluate/validate coexpression systems

Protocol standards

QA standards

Automate

Scale up

Multiple forms of proteins

Protocols

ID binding partners

To develop and incorporate the necessary technologies and methods into a high-throughput production environment, a phased process will be followed as described in this roadmap. The process includes research, design, and development; modular and pilot-scale deployment; and final integration and scaleup into operational procedures.