Featured Resources
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STORM Therapeutics: From Lead to Pre-Candidate Nomination in 18 Months
STORM Therapeutics: From Lead to Pre-Candidate Nomination in 18 Months
Case study
Why Early Process Chemistry Matters
Early-stage synthetic chemistry is designed for exploration. Medicinal chemists rightly focus on flexibility and rapid iteration to chase promising SAR. But without process chemistry input, routes can evolve that are:
- Inefficient or unsafe at scale
- Dependent on scarce or costly reagents
- Vulnerable to variability between batches
- Difficult to transfer to manufacturing partners
By introducing process chemistry expertise early, you build scalability into your discovery process, without slowing innovation.
The Embedded Advantage
At Sygnature Discovery, we’ve refined a model that works: embedding one or two process chemists into a small (5–10 person) medicinal or synthetic chemistry team.
These process chemists:
- Troubleshoot problematic steps before they become critical
- Develop robust, reproducible routes behind the scenes
- Free medicinal chemists to focus on creative discovery
- Anticipate tech transfer needs from day one
It’s a win-win. Chemistry teams move faster, scale-up is smoother, and customers save both time and cost as programs mature. In every case where clients have tried this approach, they’ve kept it.
Featured Case Study
RP-6306, Lunresertib®
WO 2020/195781 A1 & J. Med. Chem.
2022, 65, 15, 10251-10284
From Gram to Kilo Without the Pain Points
Our process chemistry support is designed to deliver fit-for-purpose material at every stage, whether that’s grams for in vivo studies or kilos for toxicology batches.
By working closely with our separation sciences and analytical teams, we eliminate the bottlenecks that often slow scale-up.
Featured Case Study
Key Intermediate Rescue
WO 2020/078875 A1
Navigating the Preclinical-to-Clinical Transition Smartly
We’re not against GMP, in fact, when regulations require it, we’re fully supportive of making that step. But many of the activities during the transition from CRO-led preclinical to CDMO-led clinical development don’t need to be GMP from the outset.
The regulations allow for flexibility, and using it wisely can save both time and budget without compromising quality.
Our approach helps customers:
- Deliver at scale key intermediates that feed directly into GMP processes
- Develop GMP-ready processes in advance so the CDMO can start with confidence
- Consult strategically to help navigate the complex “grey zone” between preclinical and clinical, avoiding over-engineering where it’s not required
By staying alongside our clients during this transition, we help ensure the journey is cost-efficient, low-risk, and primed for success.
Featured Case Study
RP-3500, Camonsertib®
WO 2025057106 A1 & J. Med. Chem.
2024, 67, 7, 10251-10284
Conclusion: Start Strong, Scale Fast
In preclinical drug discovery, process chemistry is the bridge between creativity and commercial reality. By integrating it early, you don’t just get to your IND faster, you get there with fewer risks, more confidence, and the right foundations for clinical success.
