Demands on a drug’s synthetic process naturally evolve during its life cycle. Scouting alternate routes early in process development offers significant benefits.

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API Synthetic Route
Scouting Strategies

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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

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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

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• 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

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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 >
visit neulandlabs.com >
Routes Matter!