CritiTech

What CritiTech does

CritiTech, Inc. is a privately-held pharmaceutical Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) headquartered in Lawrence, Kansas. Founded in 2001 based on supercritical precipitation research conducted at the University of Kansas by co-founder Bala Subramaniam, the company engineers drug particles to address bioavailability, solubility, and delivery challenges for poorly soluble compounds, which represent an estimated 70-90% of pharmaceutical pipelines. Its proprietary Purcision™ Supercritical Precipitation (SCP) platform produces pure drug particles (0.5-5µm, >20m²/g surface area) without excipients and is supplemented by pharmaceutical spray drying, jet milling, and dedicated cytotoxic manufacturing capabilities following a 2020 facility expansion.

CritiTech earns revenue primarily through professional services fees from CDMO/CRO engagements, executing project-based contracts that span pre-formulation, formulation development, analytical method development, GMP manufacturing, fill-finish, and CMC consulting. Customers range from early-stage startups through Top 15 global pharmaceutical companies, with named development partners including NanOlogy (oncology drug development, formed 2015 from CritiTech's technology) and Aeon Respire (inhaled niclosamide for respiratory disease, exclusive SCP licensing deal signed January 2022). A licensing/royalty stream supplements service revenue. The company has developed more than 220 compounds across a dozen drug classes, with four Purcision-enabled drugs entering the clinic and three currently in seven Phase II trials; composition-of-matter patents extend protection through 2036.

The go-to-market model is direct enterprise field sales: CritiTech engages pharmaceutical leadership and technical teams to position itself as a long-term extension of customers' own operations, supported by a website, LinkedIn presence, scientific publications, and case studies. Citation of Top 15 Pharma accounts, the CSO's involvement in 20+ FDA-approved drugs including Cardizem CD, and a Juried Award nomination for Most Promising Drug Delivery Technology at the 2025 Outsourced Pharma CDMO Leadership Awards underscore its positioning as a specialized, science-led niche CDMO rather than a high-volume commercial manufacturer.

Name

CritiTech

Legal name

CritiTech, Inc.

Website

https://crititech.com

Company type

Private

Founded year

2001

Operating status

Operating

Headcount range

11–50 employees

Short description

CritiTech is a privately-held pharmaceutical CDMO and CRO in Lawrence, Kansas that engineers drug particles using proprietary Purcision supercritical precipitation and spray drying technologies to address bioavailability and delivery challenges for poorly soluble compounds, serving clients from startups through Top 15 Pharma.

Ownership category

akta.pro rank

Product category

Pharmaceutical CDMO/CRO Services

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254)

akta.pro primary industry

GMP Scale-Up, Tech Transfer & Process Validation (PPQ) (HLAGAHAL)

akta.pro secondary industry

CMC & Pharmaceutical Development (Formulation/Process/Analytical Development) (HLAIALAD)

Keywords

• Pharmaceutical CDMO services
• Particle engineering solutions
• Supercritical precipitation technology
• Spray drying services
• Drug formulation development

Headquarters

HQ city

Lawrence

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales

Revenue model

1. CDMO Services: Contract Development and Manufacturing Organization providing pharmaceutical development services spanning from early-stage development and pre-formulation through GMP production. Services include particle engineering, analytical services, manufacturing, and fill-finish capabilities.
2. CRO Services: Contract Research Organization services including pre-formulation studies, formulation development, analytical method development and validation, and CMC consulting.
3. Licensing and Strategic Partnerships: Strategic collaboration and licensing agreements for proprietary technology (e.g., SCP Technology) for specific therapeutic applications like the Aeon Respire niclosamide collaboration.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

CritiTech is a pharmaceutical Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) that provides particle engineering and drug development services from early-stage pre-formulation through GMP production. Its proprietary Purcision Supercritical Precipitation (SCP) platform and spray drying capabilities produce engineered drug particles with optimized size, shape, and surface area to solve bioavailability, solubility, and cytotoxic formulation challenges for pharmaceutical customers.

Product overview

CritiTech is a full-service pharmaceutical CDMO and CRO providing integrated drug development services from early-stage pre-formulation through GMP manufacturing. The company operates two core proprietary technology platforms—Purcision™ Supercritical Precipitation (SCP) and Spray Drying (SD)—which are complemented by a comprehensive suite of analytical, manufacturing, fill-finish, and consulting services. These technologies are applied across their drug formulation development, particle engineering, and inhaled drug formulation services to solve bioavailability challenges for poorly-soluble compounds. The service portfolio is supported by in-house quality assurance, CMC consulting, and method development capabilities, enabling end-to-end project management from proof-of-concept through clinical production.

Differentiator

Problem solved

Functional benefit

Brands

• Purcision™: Proprietary supercritical precipitation (SCP) drug development platform that engineers particles for optimal drug efficacy, focusing on specific surface area optimization rather than just particle size reduction.
• Purcision Supercritical Precipitation (SCP)
• Purcision SCP

Products and services

• Purcision Supercritical Precipitation (SCP) Proprietary supercritical precipitation drug development platform that engineers particle characteristics—size, shape, polymorph, and surface area—to maximize drug efficacy, producing 100% pure drug particles without excipients. Used by pharmaceutical customers to improve bioavailability of poorly soluble compounds.
• Pharmaceutical Spray Drying (SD) Contract spray drying service that converts liquid formulations into dry powders using single-pass nitrogen systems, handling aqueous or organic solvent systems, peptides, biologics, oxygen-sensitive, hygroscopic, and cytotoxic/potent compounds. Used by pharmaceutical customers from POC through GMP.
• Pre-Formulation & Material Characterization Early-stage drug formulation service including physicochemical assessments, particle characterization (XRD, PSD, SSA, B/T density, SEM), solubility analysis, and stability analysis to establish target product profiles for pharmaceutical customers.
• Jet Milling Particle size reduction service using air jet mill technology where coarse powder is suspended in high-volume air flow; particles of the desired smaller size are collected and larger particles are recycled through the system.
• Drug Formulation Development Full-service drug formulation development spanning pre-formulation studies, formulation development, and application of Purcision SCP, Spray Drying, and Jet Milling to address various routes of administration for pharmaceutical customers.
• Particle Engineering Drug particle engineering service using spray drying and supercritical precipitation to modify particle size, shape, crystalline phase, surface area, solubility, and dissolution for improved bioavailability and efficacy.
• Analytical Services Comprehensive pharmaceutical analytical testing including method development/validation, particle size analysis (laser diffraction, NGI), BET surface area, residual solvent determination, crystallinity analysis (XRD, DSC), and full ICH stability testing.
• Method Development Analytical method development and validation services including UV/Vis, GC, and HPLC method development, transfer, verification, and validation of USP and non-pharmacopeia methods.
• Manufacturing & Process Development Pharmaceutical manufacturing and drug process development services from milligrams to hundreds of kilograms scale, supporting cytotoxic, non-cytotoxic, potent, and DEA Schedule II–V compounds.
• Fill-Finish Services Comprehensive fill-finish capabilities including automated blending, capsule filling (000-5 tooling), and vial filling for solid pharmaceutical products from early stage through clinical trials.
• Quality Assurance Pharmaceutical quality assurance systems and cGMP compliance oversight including batch records, equipment validation, SOP systems, OOS procedures, CAPA tracking, and internal audit programs.
• CMC Consulting Chemistry, Manufacturing, and Controls (CMC) consulting including project management, regulatory filings (INDs, NDAs), process validation, stability programs, and technical business support for drug development.
• Purcision Inhaled Drug Formulation Inhalation drug development platform using Purcision SCP technology to engineer particles with ideal aerodynamic properties (1–10 µm MMAD) for pulmonary delivery, optimal lung retention, and bioavailability, targeted at respiratory drug developers.

Quantifiable outcome

• Surface area increase of 271% compared to raw material (NanoPac paclitaxel)
• +5 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Two partnerships are on record, tiered core.

• Aeon RespirecoreStrategic or Co-development Partner · 25 January 2022Strategic collaboration and licensing agreement for development of novel inhaled niclosamide formulation using CritiTech's proprietary SCP Technology. Aeon has exclusive rights to SCP Technology covering SCP Inhaled Niclosamide for treatment of severe asthma, COPD, viral infections including COVID-19, and other respiratory diseases. Includes access to CritiTech's proprietary SCP manufacturing capabilities and ongoing scientific collaboration.
• NanOlogycoreStrategic or Co-development PartnerLong-standing partnership for oncology drug development. NanOlogy uses CritiTech's supercritical precipitation technology for developing submicron particle taxane formulations (NanoPac, NanoDoce, SOR007) for targeted tumor therapy. Multiple clinical trials advancing across lung, pancreatic, prostate, ovarian, peritoneal, bladder, and dermal cancers. NanOlogy was formed in 2015 based on CritiTech's technology.

Scale indicators5 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Quotient Sciences: Integrated drug development services provider combining formulation development, GMP manufacturing, and clinical pharmacology. Overlaps with CritiTech on formulation/particle engineering services and CDMO offerings, particularly for early-to-mid-stage pharma customers.
• Frontage Laboratories: CRO/CDMO providing formulation development, analytical services, and GMP manufacturing for small molecules and biologics. Comparable to CritiTech on integrated CMC, analytical, and CDMO service model for pharma customers.
• Upperton Pharma Solutions: UK-based formulation development and GMP CDMO offering spray drying, particle engineering, and inhaled drug development. Comparable to CritiTech as a smaller specialist CDMO focused on spray drying and formulation problem-solving for pharma customers.
• Bend Research (Lonza): Spray drying and particle engineering CDMO now part of Lonza, historically focused on solubility enhancement and inhaled formulations. Closely comparable to CritiTech on technology platform (spray drying for bioavailability), customer base (Big Pharma), and respiratory drug development.
• Particle Sciences (Lubrizol): CDMO specializing in complex drug formulation, particle engineering, and GMP manufacturing for poorly soluble compounds, including inhalation and sterile injectable formats. Direct overlap with CritiTech's particle engineering, pre-formulation, and analytical services for bioavailability-challenged molecules.
• Hovione: Portuguese CDMO with deep particle engineering, spray drying, and supercritical fluid processing capabilities serving pharma and inhalation customers. Hovione's particle engineering focus and proprietary processing platforms are directly comparable to CritiTech's Purcision SCP and spray drying offerings.
• Halo Pharma: Small-to-mid CDMO offering formulation development, analytical, and GMP manufacturing services for solid, liquid, and semi-solid dosage forms. Similar size and service positioning as CritiTech, competing for similar pre-clinical to clinical-stage CDMO contracts.
• Recro Gainesville: CDMO providing formulation development, analytical services, and GMP manufacturing for oral solid dose and sterile products. Comparable in scale and CDMO service mix to CritiTech, with similar focus on complex formulation challenges.

Broad incumbents

• Catalent: Large global CDMO offering a broad portfolio including softgel, oral solid, biologics, and inhalation development. CritiTech leadership includes multiple Catalent alumni (VP Quality, CSO); Catalent competes with CritiTech in CDMO particle engineering and inhaled drug development at a much larger scale.
• Lonza: Global CDMO leader providing services across small molecules, biologics, and cell & gene therapy, including particle engineering via its Bend Research acquisition. Comparable platform overlap with CritiTech on spray drying and bioavailability services, but at dramatically larger scale and broader service scope.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/crititech-inc-
• Facebookfacebook.com/141880592524200

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Funding overview

Funding rounds5 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about CritiTech