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Table 5. Roadmap for Development of Technologies to Produce Affinity Reagents (acronyms)

Objectives Subtopics

Research

Pilots

Production

Products

Affinity-Reagent Library Development

Useful molecular scaffolds developed

Useful libraries constructed and evaluated

Design validated

Expression tested

System compatibility tested

Automate library

Protocol standards

QA, standards

Scale up

Affinity reagents

Reagent chips

Protocols

QA, standards

Affinity-Screen Automation

Develop protocols

Scale up to 2k/year

Protocol standards

QA, standards

Scale up to 25k/year

Affinity reagents

Reagent chips

Protocols

QA, standards

Affinity-Reagent Target Design

Novel vectors

Validate designs

Integrate into protein production system

Protocol standards

QA, standards

Scale up

Immobilized targets

Protein chips

Protocols

QA, standards

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.