Spirochem

Route scouting

Identifying novel efficient routes of synthesis to enable large-scale manufacturing of compounds. Learn more!

Bridging Discovery and Process Chemistry

Route Scouting

Identifying viable, robust and scalable synthetic routes

Choosing the wrong chemical route wastes time, money, and effort, and often fails at scale. Our route scouting approach removes uncertainty, enabling the selection of robust and scalable synthetic strategies to keep development on track.

Route scouting involves the strategic identification and evaluation of efficient and scalable synthetic routes. This approach is tailored to the specific requirements of the target compound. Leveraging our expertise in chemical process development, deep organic chemistry knowledge, and incorporating insights from our clients, we evaluate a range of feasible strategies to rapidly prioritize and advance the most promising options.

Alternative routes are designed and prioritized based on their potential for scale-up, considering projected cost of goods, scalability, and development feasibility. SpiroChem’s route scouting efforts also encompass the exploration of novel synthetic methodologies and the use of advanced modern technologies to enable innovative disconnections and meet sustainability criteria that are often difficult to achieve with more traditional chemistry.

After disclosure of the target molecule by the client, our approach consists in:

Analyze-Brainstorm-Propose

  • Critically analyze available data
  • Brainstorm and generate alternatives, from complete de novo synthesis to smart tuning or orchestrating of existing sequences

Experimental Route Scouting

  • Test, challenge and rank ideas on sub-gram scale (fail-fast approach leveraging our HTE platform)
  • Critically assess the viable routes and select the most promising one
  • Perform scale-up to evaluate scalability

Development / Optimization

  • Screen alternative reaction conditions (HTE Platform)
  • Telescop steps
  • Implement purification strategies
  • Check impurity profile
  • Develop meaningful in-process controls
  • Test reproducibility

A demo batch is usually performed on a 10’s to 100’s g scale to test the robustness of the novel synthesis. A tech transfer package will then be prepared, with SpiroChem supporting the transition to customer’s CDMO of choice.

Identifying novel efficient routes of synthesis to enable large-scale manufacturing of compounds. Learn more!

Case Studies

How Effective Route Scouting Saved a Project from Disaster

This is a story about how SpiroChem rescued a failed tech transfer from near disaster and turned it into a success. A story about a promising molecule’s path to phase 1 clinical trials, jeopardized by an unoptimized synthetic route.

Identifying novel efficient routes of synthesis to enable large-scale manufacturing of compounds. Learn more!

When a Swiss biotech contacted SpiroChem, they were at a critical point. Their tech transfer to their CDMO of choice failed during the 5th step (out of 6), leaving them with kilograms of unusable crude reaction mixture.

In just three months, SpiroChem redesigned the process into a 2-step synthesis, introducing stereocenters last via C-H activation. Then successfully delivered 200g of compound for toxicology studies, followed by a seamless tech transfer to a Swiss CDMO.

De Novo Route Design Driving Real Impact in Late-Stage Development

At SpiroChem, we leverage advanced molecular design and route-scouting technologies to help biotech and pharmaceutical teams overcome synthesis and scale-up bottlenecks. Complex spirocyclic building blocks shouldn’t stand in the way of a Phase III program—but for one U.S.-based biotech company developing an oncology candidate, that was exactly the challenge.

Customer’s route faced:

  • A long, inefficient synthesis
  • Low overall yield
  • Costly steps that threatened project timelines and commercial viability
Identifying novel efficient routes of synthesis to enable large-scale manufacturing of compounds. Learn more!

Our Approach:

SpiroChem partnered with the biotech team to rethink the chemistry from the ground up. In just six months, we delivered a fully redesigned synthetic route that:

  • Reduced the sequence from 7 steps to 5 (2-pot)
  • Increased overall yield from 10–15% to 70–80%
  • Replaced seven chromatographies with just two precipitations
  • Eliminated Pd-catalyzed and CO-based steps, using robust, scalable reagents

This collaborative network ensures that each HTE campaign can leverage the best available catalysts and technologies, accelerating optimization and increasing the rate of success.

The Results:

  • Production of a 500 g demonstration batch
  • Smooth tech transfer to >100 kg scale
  • Filing of a joint patent Support toward the drug’s successful commercial launch

What our clients
say about us

As a reliable partner with a world-class team of chemistry experts, SpiroChem delivers high-quality solutions offering you the ‘best chance of being successful’

Testimonials
Identifying novel efficient routes of synthesis to enable large-scale manufacturing of compounds. Learn more!
“SpiroChem is an excellent partner for several reasons. They have strong chemists who are collaborative, creative, knowledgeable, innovative, and hard working. Over the course of a one-year Route Scouting project, they generated many ideas for new synthetic routes and aggressively explored each of the ideas for application to a very challenging structural motif that required a broad understanding and good command of asymmetric methodologies. In addition to generating and applying new ideas, they were also quite successful at making measurable improvements to existing synthetic processes...I have no reservations in recommending SpiroChem as a partner for challenging Route Scouting projects...I look forward to working with the team again on a future project."

Michael D. Wallace, Director, Process Development and Manufacturing, Assembly Bio

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