SUPERCRITICAL CO₂

PROCESS DEVELOPMENT

PREPARATIVE SFC

API INTERMEDIATES

BIOCONJUGATE CHEMISTRY

DISCOVERY TO DELIVERY

Integrated CDMO and CRO Partner

Pharmaceutical Development Supercritical Solutions

End-to-end contract development, research, and preparative manufacturing for small molecules, bioconjugates, peptides, and oligonucleotides. Anchored by a supercritical fluid platform that brings speed, selectivity, and green chemistry to every project.

Start a Project Our Services

What We Do

Four Core Services

Integrated contract development, research, and manufacturing services for pharmaceutical and biotech programs. From discovery through commercial supply, with a supercritical fluid platform threaded through every stage.

Contract Development
and Manufacturing

Route design, process development, and preparative manufacturing for active pharmaceutical ingredients, advanced intermediates, and new modalities. Phase-appropriate work from preclinical supply through commercial launch.

API and intermediate process development
Bioconjugate payload-linker chemistry
Formulation and drug product development
Phase-appropriate quality across the lifecycle

Contract Research
Services

Discovery and medicinal chemistry, custom synthesis, hit-to-lead and lead optimization support, and reference-standard work. Embedded scientific teams for early-stage programs that need flexibility, not boilerplate.

Discovery and medicinal chemistry support
Custom synthesis of complex building blocks
Hit-to-lead and lead optimization
Reference standards and impurity isolation

Preparative Chromatographic Manufacturing

Supercritical fluid chromatography and orthogonal liquid chromatography as a primary manufacturing tool — not a back-room enabling technology. Chiral resolution, impurity removal, and final-step polishing under appropriate quality systems.

Preparative SFC for chiral and achiral separation
Preparative liquid chromatography
Method development for prep-scale isolation
Material delivery with full analytical packages

Analytical and
Regulatory Support

Method development and validation across NMR, mass spectrometry, HPLC, GC, and orthogonal techniques. CMC support and regulatory dossier work tuned for cross-jurisdictional filings — from IND through marketing authorization.

Analytical method development and validation
Structural elucidation and impurity profiling
Stability programs aligned to ICH guidance
CMC dossier preparation and review

Modality Expertise

Four Therapeutic Modalities

We work across the modalities where modern drug discovery and development is moving — and where supercritical fluid chemistry genuinely earns its place alongside conventional approaches.

// Modality 01

Small Molecule APIs and Intermediates

Active pharmaceutical ingredients and advanced intermediates across oncology, central nervous system, cardiovascular, anti-infective, and metabolic therapeutic areas. Route design, asymmetric synthesis, chiral resolution, and final-step polishing — with SFC available wherever it outperforms conventional approaches.

From discovery synthesis through commercial manufacturing

// Modality 02

Bioconjugates and ADCs

Antibody-drug conjugates, peptide-drug conjugates, and radionuclide-drug conjugates. Payload synthesis, linker chemistry, conjugation development, and drug-substance process work. SFC purification protects sensitive payloads where aqueous chromatography degrades them.

ADC, PDC, and RDC payload-linker programs

// Modality 03

Peptide Therapeutics

Solid-phase and solution-phase peptide synthesis, complex cyclic and stapled peptides, and peptide intermediates. Preparative chromatographic purification is the final-step workhorse for peptide therapeutics, and supercritical fluid methods extend the toolkit for difficult separations.

Linear, cyclic, and stapled peptide chemistry

// Modality 04

Oligonucleotides and Nucleoside Chemistry

Phosphoramidite building blocks, modified nucleosides, and oligonucleotide intermediates for antisense, siRNA, and other oligo therapeutics. Anhydrous supercritical CO₂ environments protect moisture-sensitive intermediates during purification — a fit-for-purpose advantage over protic mobile phases.

Phosphoramidite, ProTide, and modified nucleoside work

The Platform

Supercritical Fluids as a Platform

Supercritical CO₂ is more than a mobile phase. We use it as a separation medium, an extraction solvent, a reaction medium, and a particle-engineering tool — bringing the same speed, selectivity, and green-chemistry benefits to every stage where conventional approaches fall short.

// Supercritical Fluid Chromatography

SFC for chiral resolution, achiral separation, and final-step polishing. Orthogonal selectivity to liquid chromatography resolves what HPLC cannot, and the low-viscosity mobile phase enables faster cycle times under gentler conditions.

// Supercritical Fluid Extraction

SFE for natural-product isolation, residual-solvent removal, and selective extraction of thermally labile or sensitive compounds. Tunable density and selectivity, with no organic-solvent residues in the recovered product.

// Green Reaction Medium

Supercritical CO₂ as a non-toxic, non-flammable, recoverable solvent for hydrogenation, oxidation, and other process-chemistry reactions. Reduced organic-solvent load and simplified downstream workup compared to conventional approaches.

// Particle Engineering

Supercritical antisolvent and rapid-expansion processing for controlled particle size, morphology, and polymorph selection. Useful for poorly soluble APIs, inhalation formulations, and amorphous solid dispersions where conventional milling falls short.

SFC

Separation

SFE

Extraction

SC-CO₂

Reaction Medium

Engagement Model

From Concept to Delivery

A clear path from project scoping through material delivery, with the same partners and the same quality system at every step.

Consultation

Scope the program, assess feasibility, and align on target profile, timeline, and quality expectations

Development

Route design, process and method development, screening and optimization across synthetic and analytical work

Manufacturing

Preparative chromatographic and synthetic manufacturing under phase-appropriate quality oversight

Delivery

Material with full analytical and quality documentation, plus transferable methods for downstream work

The Integrated Platform

Discovery, development, manufacturing, and analytical sciences under one roof — purpose-built to move programs from concept through delivery without handoff friction.

Discovery and Synthesis

Medicinal chemistry, custom synthesis, building-block libraries, and route scouting. Embedded teams that work alongside discovery scientists rather than waiting at the end of a queue.

Supercritical Fluid Operations

SFC, SFE, supercritical reaction medium work, and particle engineering under one platform. The technology stack runs through every modality we serve — from small molecules to peptides to oligonucleotides.

Analytical and Quality

NMR, mass spectrometry, HPLC, GC, and orthogonal analytical techniques tied to a quality system that grows with the program — from early discovery through later-phase development.

Get Started

Initiate Contact

A small-molecule API that needs a new route. A bioconjugate program that needs payload-linker work. A peptide or oligonucleotide intermediate that needs purification. Tell us about the project — we will scope it together.

// What to Send Us

A description of the program, the target profile, the modality, the stage of development, and the constraints that matter to you. We will assess fit, suggest a path, and propose an engagement within a few business days.

// Typical Engagement

Scoping and feasibility, then a structured development phase, then preparative work and material delivery — with a single point of contact and a single quality system throughout. Confidentiality agreements available at first contact.

// Transmit Inquiry

info@kiralitypharma.com

Our team responds within one business day. CDAs available upon request.