The document discusses the importance of scouting alternate synthetic routes in pharmaceutical development, emphasizing cost reduction, efficiency, and sustainability. Key strategies include using inexpensive starting materials, minimizing purification needs, and ensuring compliance with patent laws. By optimizing these processes, companies can achieve significant improvements in processing time and environmental impact.

1. 1
API Synthetic Route
Scouting Strategies

2. 2
Demands on a drug’s synthetic process naturally evolve
during its life cycle. Scouting alternate routes early in
process development offers significant benefits.
Why Use Early Stage
Synthetic Route Scouting

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Decrease
processing
times
Improve
Quality &
Safety
Profiles
Reduce processing steps or complexity
Improve scalability
Reduce chemical
or reagent
use & waste
production
Benefits of Alternate Route Development

4. 4
Pharma companies realize the core benefits of
process optimization:
• Cost
• Efficiency
• Safety
Increased Demand for Route Scouting

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• Cost-effective
• Same or greater quality
than existing route
• Reasonable time-to-market
How Much Improvement Should You Expect?
• Niche drugs: cost reductions of 2-5% via alternate route
• Generics: cost reductions of 5+% via alternate route
Combined, these 3 criteria can often fulfill
of 80-90% of business goals.
Focusing on just one or two of these criteria
can bring significant improvement.
What to Look For in New Synthetic Routes

6. 6
• Use a strategically inexpensive
starting material — ideally an
intermediate from an existing
process.
• Processes should be robust and
require minimal purification.
Stages should be telescoped for
maximum efficiency.
Alternate Route Scouting Basics

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• Ensure the new route does not infringe any current
patents.
• Understand starting material shelf lives and retesting
periods.
• Identify impurities and
byproducts. Avoid routes
with genotoxic impurities.
Alternate Route Scouting Basics

8. 8
Shortening the route is a common a goal due to its
outsized impact. This single change can decrease cost,
time, waste and regulatory constraints.
TIP: Focus on Shortening the Batch Cycle

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• Batch sizes
• Throughput of the product
• Lead time
Other Top Factors to Consider

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Determine if alternate green reagents can be used to
maximize long-term product sustainability.
Innovative routes use the fewest
resources possible and minimize
environmental impact.
in pursuit of
atom economy
TIP: Go Green for Long-Term Success

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Synthetic route selection is an essential part of API scale-up
and manufacturing. A new synthetic route should meet your
expectations and be sustainable for the long-term.
learn more >
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Routes Matter!