PROCESS R&D · COMPLEX APIs, PEPTIDES & INTERMEDIATES
Novel routes to complex APIs.
Polarix designs original, non-infringing routes for complex APIs, peptides, and intermediates — and engineers them into scalable processes.
WHY POLARIX
Innovation in process chemistry.
Most complex APIs are still made by the first route that reached the clinic. That route was built for speed, not for yield, impurity control, or scale.
We re-engineer it for scale, from the retrosynthesis up.
We design the route. We scale the process.
SERVICES
How we can collaborate
Route design
For an API or intermediate with no viable route, or one blocked by patents.
Process development
For an API process limited by yield, impurities, or hazardous steps.
Scale-up & technology transfer
For a lab process that has to run reliably at commercial scale.
Process licensing
License a scalable process from our portfolio.
Mutual NDA before any technical detail is shared.
A clear IP position from day one.
On-site support from the team that built the process.
HOW POLARIX WORKS
From target molecule to scalable supply.
Four stages, each with a defined deliverable. The same team stays on the molecule from the first disconnection to the first plant batch.
An original route, selected on data.
Retrosynthetic analysis maps the candidate route space. Routes are ranked on convergence, step economy, PMI, projected COGs, starting-material availability, and freedom-to-operate.
Every step demonstrated at lab scale.
Each step is run and isolated in the lab. Structures, isolated yields, and impurity profiles are confirmed by NMR and HPLC-MS — and reproduced across repeat runs.
From lab procedure to plant-ready process.
Kinetics, calorimetry, and mixing and heat-transfer constraints define the scale-up parameters. Crystallization and workup are designed for plant equipment, and impurity purge becomes a defined control strategy — CPPs, CQAs, PARs.
Into the plant — with us on the floor.
Process description, master batch records, and validated analytical methods transfer to the partner site. Polarix supports engineering and demonstration batches through PPQ — person-in-plant, not email support.
CAPABILITIES
Small molecules, peptides, and the linkers between them.
Small molecules
Stereochemically demanding, multi-step targets — set catalytically, run safely, made to scale.
Conjugation & linkers
Where a small-molecule payload meets a peptide — the chemistry that makes a conjugate one molecule.
Peptides
Therapeutic peptides where generic capacity stalls — sequence, form, and yield solved together.
Engineered for manufacture
Whatever the chemistry, the discipline is the same — routes designed, validated, and built to run at scale.
Accelerated by our own data
Routes proposed, conditions optimized, and scale-up de-risked with models trained on our campaign data — not generic predictions.
PORTFOLIO
Routes developed ahead of demand.
Complex chemistry — that is where we work. Partners license a validated process instead of starting from scratch.
PX-01 · Metabolic
GLP-1/GIP Intermediate
A key intermediate for GLP-1/GIP therapies, supplied today by a handful of manufacturers. We are developing a higher-yielding, scalable route designed for freedom to operate.
PX-02 · Rare Disease
CFTR Modulator API
A complex, multi-step small molecule with few established manufacturers. We are developing a differentiated route aimed at lower cost of goods and an independent patent position.
PX-03 · Metabolic
Oral Non-Peptide GLP-1
A new therapeutic class with few established routes. We are designing routes and strategic building blocks for the leading candidates.
Available for co-development or licensing. Route details shared under NDA.
WHO WE WORK WITH
We enable our partners. We don't compete with them.
We work with manufacturers, innovators, governments, and research institutions — from the first route to commercial scale.
CDMOs & Manufacturers
Scale validated complex API processes inside your own manufacturing capacity, with Polarix working alongside your technical team.
We design. We scale with you.
Generics, Formulators & Innovators
Access novel, non-infringing routes for strategic APIs and intermediates, developed toward reliable production.
Better chemistry for differentiated supply.
Governments & Health-Security Programs
Localize production of critical APIs and intermediates through technology transfer and partner-site scale-up.
Reduce dependence. Build resilience.
Research Institutions & CROs
Collaborate on advanced intermediates, reference standards, route development, and complex building blocks.
Specialized chemistry for difficult molecules.
TEAM
Founders & Leadership
Synthetic chemistry, AI-assisted route design, and decades of pharmaceutical leadership.
Dr. Ramesh Ramapanicker
Professor of Chemistry, IIT Kanpur. 100+ publications in synthetic chemistry, catalysis, and green chemistry. Leads scientific direction.
Mohit Nihalani
MSc Computer Science, NYU Courant. Leads computational route design and company strategy.
PARTNER WITH US
Tell us the molecule. We’ll build the route.
A new route, a better process, a scale-up problem, or a license to a process in our portfolio — tell us the molecule and the stage it is at. We put an NDA in place before any technical detail is exchanged.
contact@polarix.bioWHAT HAPPENS NEXT
- 01Intro call and mutual NDA
- 02Feasibility and patent-landscape review of your molecule
- 03Proposal with scope, deliverables, and IP terms