Triclinic labs

What Triclinic labs does

Triclinic Labs is a privately held contract research organization (CRO) founded in 2009 and headquartered in Lafayette, Indiana, that delivers physical and analytical chemistry services with a focus on solid-state chemical development and materials characterization. The company's core offerings span polymorph, salt, and cocrystal screening and selection; amorphous materials characterization and amorphous solid dispersion development; crystallization method development; and an extensive analytical techniques portfolio including XRPD (including micro-crystal electron diffraction and combined reflection/transmission methods developed in-house), DSC, TGA, FTIR, Raman, NMR (solids and liquids), HPLC, UPLC, GC, mass spectrometry, particle sizing, elemental analysis, microscopy, and chemical imaging. Triclinic also operates a Materials Modeling group that combines Total Diffraction Modeling, TTT (humidity-temperature transformation) modeling, and Chemometric Matrix Correction for solid-state quantitative methods. The business serves pharmaceutical, fine chemical, medical device, agrochemical, oil/gas/mining, and emerging CO2 sequestration clients through a direct B2B sales motion in which engagements begin with mutual NDA execution, followed by expert-to-expert project scoping, proposal generation, and ongoing direct scientist-to-client communication without project manager intermediaries.

The company generates revenue exclusively through professional-services contracts on a quote-based, per-project model with multiple service levels and rush-request options, offering both cGMP and non-GMP testing. Triclinic is an FDA-registered and inspected laboratory (most recent 2024 inspection, zero Form 483 observations), holds a DEA Controlled Substance License covering Schedules I-V, and is cGMP-compliant — enabling it to perform compendial testing (USP/BP/EP/JP), validated method development and transfer, and lot release work. It also provides chemical intellectual property support covering patent prosecution, expert witnessing, prior art reproduction, and Paragraph IV ANDA litigation, with scientists having served as experts in more than 200 IP matters worldwide over 25 years. Triclinic claims a 98.3% historical client repeat rate and has completed several thousand solid-state development projects across every therapeutic class of active pharmaceutical ingredients. The company is organized as Triclinic Labs, LLC., is independently owned with no disclosed venture or private equity backing, and operates with a leadership team of Shawn C. Comella (CEO), G. Patrick Stahly (COO), and David E. Bugay, Ph.D. (CSO, AAPS Fellow).

Name

Triclinic labs

Legal name

Triclinic Labs, LLC.

Website

https://tricliniclabs.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

11–50 employees

Short description

Triclinic Labs is a US-based contract research organization providing solid-state chemical analysis, materials characterization, and intellectual property support services to pharmaceutical, chemical, medical device, and energy-sector clients from its FDA-registered, DEA-licensed laboratory in Lafayette, Indiana.

Ownership category

akta.pro rank

Product category

Contract Research Services (Analytical Chemistry and Solid-State Development)

NAICS

Testing Laboratories and Services (54138), Testing Laboratories and Services (541380), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Testing Laboratories (8734), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Material Characterization & Spectroscopy (NMR/FTIR/MS) (HLAGADAK)

akta.pro secondary industries

Release Testing & Batch Certification (QC) (HLAGADAC), Small-Molecule Analytical Development & Method Validation (CMC) (HLAGAHAF), Impurity / Reference Standard Synthesis & Characterization (HLAGAHAG)

Keywords

• Contract research services
• Solid-state development
• Analytical chemistry services
• Materials characterization
• Pharmaceutical IP support

Headquarters

HQ city

Lafayette

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Research Services - Analytical Chemistry and Materials Characterization: Provides physical and analytical chemistry testing services including pharmaceutical materials analysis, contaminant identification, reference standard characterization, bulk powder characterization, particle size analysis, and cGMP analytical method development and validation. Services offered on a per-project basis with multiple service levels ranging from routine to rush requests. Both cGMP and non-GMP services available.
2. Solid-State Form Development: Includes polymorph and salt screening and selection, cocrystal screening, crystallization method development, and problem solving for improvement of physical and chemical properties. Also covers amorphous materials and solid dispersion development including spray drying and hot melt extrusion formulation services.
3. Intellectual Property Support Services: Chemical patent prosecution and litigation support including consulting expert witnesses, litigation support (testifying and non-testifying experts), reproduction of prior art, infringement analysis, patent prosecution support, Paragraph IV ANDA litigation support, and scientific demonstrative consulting.
4. cGMP Method Development, Validation, and Lot Release: FDA-registered and DEA-licensed (Schedules I-V) laboratory providing cGMP release testing, compendial testing (USP/BP/EP/JP), and analytical method transfer services for pharmaceutical and fine chemical clients.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels9 records

Core offering

Triclinic Labs is a contract research organization that performs physical and analytical chemistry services for pharmaceutical, fine chemical, medical device, agrochemical, and energy/mining clients. Core offerings span solid-state development (polymorph and salt screening, cocrystal development, amorphous material characterization, crystallization method development, amorphous solid dispersion via spray drying and hot melt extrusion) and materials characterization using XRPD, DSC/TGA, FTIR/Raman, NMR, HPLC/UPLC/GC, mass spectrometry, particle sizing, microscopy, and chemical imaging. The company also provides cGMP method development/validation/lot release testing, compendial testing, and intellectual property support including patent prosecution and litigation expert services.

Product overview

Triclinic Labs is a contract research organization (CRO) offering comprehensive physical and analytical chemistry services for pharmaceutical and chemical development. The company's portfolio centers on solid-state chemical development services (polymorph/salt screening, cocrystal development, amorphous materials analysis, crystallization method development) complemented by an extensive suite of analytical characterization techniques (XRPD, DSC/TGA, spectroscopy, chromatography, mass spectrometry, microscopy, particle analysis). The company provides cGMP-compliant method development, validation, and lot release testing, along with intellectual property support including patent prosecution and litigation services. Services span pharmaceutical, agrochemical, petrochemical, mining, environmental, and medical device industries.

Differentiator

Problem solved

Functional benefit

Products and services

• Polymorph and Salt Screening and Selection Comprehensive screening and selection services for polymorphs and salts to identify optimal solid forms for drug substance development and intellectual property protection.
• Cocrystal Screening, Selection, and Formulation Development Identification and development of pharmaceutical cocrystals to improve API properties including solubility, stability, and bioavailability.
• Non-Crystalline (Amorphous) Materials Characterization and Stability Prediction Analysis and characterization of amorphous materials including stability prediction using proprietary Total Diffraction Modelling and TTT modelling for non-crystalline pharmaceutical compounds.
• Amorphous Solid Dispersion Development Development services for spray-drying and hot melt extrusion formulations to create stable amorphous solid dispersions.
• Crystallization Method Development Process development services for optimal crystallization conditions to achieve desired solid forms with appropriate particle characteristics.
• Particle and Habit Engineering Particle engineering and habit control services for APIs and excipients to achieve desired physical properties and processing behavior.
• Chemical Property Improvement and Problem Solving Consulting and problem-solving engagements to address chemical and physical property issues in drug substances and drug products.
• Materials Characterization Services Comprehensive materials characterization services including XRPD, DSC/TGA, FTIR/Raman, NMR, chromatography, mass spectrometry, microscopy, particle sizing, water analysis, elemental analysis, and CMC structure elucidation for pharmaceutical and chemical clients.
• cGMP Analytical Method Development, Validation, and Lot Release Current Good Manufacturing Practice compliant method development, validation, and lot release testing services following ICH guidelines from an FDA-registered and inspected laboratory.
• Compendial Testing (USP/BP/EP/JP) Pharmacopeial compliance testing including monograph verification, system suitability, and regulatory submission support across USP, BP, EP, and JP.
• Predictive Materials Modeling and Computational Chemistry Computational materials modeling services for organic and inorganic analysis, polymorph/salt/cocrystal screening, phase transitions, and advanced method development and validation, including predictive modeling for amorphous solid dispersion development.
• Chemical Intellectual Property Support Chemical patent prosecution, litigation support, expert witnessing, prior art reproduction, infringement analysis, Paragraph IV ANDA litigation support, and scientific demonstrative consulting services.
• Contaminant and Counterfeit Analysis Identification of counterfeit products, foreign material analysis, and root cause investigation for pharmaceutical contamination incidents.
• Medical Device Analysis Drug coating characterization, defect and failure testing, dimensional and surface metrology services for medical devices including stents, catheters, and combination products.
• CO2 Sequestration Analysis Advanced elemental, structural, and thermal analysis services supporting carbon capture, mineralization, and CO2 utilization projects.
• Oil, Gas and Mining Industry Analysis Materials characterization services for the energy and mining sector including frac sand evaluation, corrosion analysis, produced water testing, and mineral phase identification.
• Peptide NMR Analysis Comprehensive NMR-based investigations for peptide structural characterization, conformational analysis, and purity determination.
• Extractables and Leachables (E&L) Testing Comprehensive extractables and leachables studies for pharmaceutical packaging, medical devices, and drug delivery systems.
• USP <901> Talc and Asbestos Testing GMP-validated methods for detecting asbestos contaminants in pharmaceutical-grade talc using XRPD and polarized light microscopy in alignment with USP General Chapter <901>.

Quantifiable outcome

• 98.3% client repeat rate historically
• +3 more outcomes

Segments5 records

Ideal customer profiles6 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• SSCI (now part of AMRI / Curia): SSCI is the original solid-state chemistry CRO whose alumni (including several Triclinic principals) helped spin out Triclinic Labs. SSCI services overlap almost exactly with Triclinic's: polymorph/salt/co-crystal screening, amorphous characterization, cGMP method validation, and IP litigation support.
• Almac Group: Global pharmaceutical services CRO offering solid-form screening, analytical development, and IP support across pharma development stages; Triclinic's Aeri Park previously served as Director of US Operations for Almac's solid-state group, and the two compete for the same pharma solid-state work.
• Crystal Pharmatech: Specialized solid-form CRO offering polymorph screening, salt/co-crystal selection, and crystallization process development with strong pharma-focused service model. Direct competitor for outsourced solid-state development projects globally.
• Intertek Pharmaceutical Services: Global testing services provider with pharmaceutical cGMP analytical, materials characterization, and pharmaceutical IP support capabilities (formerly including the Intertek Cantox consulting practice). Competes for compendial, extractables/leachables, and regulatory-driven analytical work.
• Pharmorphix (Sigma-Aldrich / Merck KGaA): Solid-state services arm of Merck KGaA / Sigma-Aldrich offering polymorph, salt, and co-crystal screening with materials characterization — the traditional in-house solid-form group that external sponsors often benchmark against when choosing between Triclinic and other specialty providers.

Broad incumbents

• Eurofins Lancaster Laboratories: One of the largest pharmaceutical contract testing networks globally, offering cGMP analytical, stability, and method validation services with broader portfolio and global footprint than Triclinic — a frequent competitor for routine compendial and method-validation work.
• Charles River Laboratories: Major CRO/CDMO providing analytical, formulation, and manufacturing services for pharma and medical devices. Overlaps with Triclinic on analytical services, method validation, extractables/leachables, and device testing but at much larger scale.
• WuXi AppTec: China-headquartered global CRO/CDMO with broad analytical, solid-state, and CMC services. Competes with Triclinic primarily on price for sponsor-discretionary solid-form and analytical projects, particularly where the sponsor wants an Asia-Pacific footprint.

Emerging players

• Particle Sciences (Lubrizol Life Science): Specialty CDMO focused on complex drug delivery including amorphous solid dispersions, nano-particles, and injectables. Comparable to Triclinic for the subset of amorphous dispersion / particle engineering work.
• Aptuit (now part of Eurofins): Former standalone discovery/CMC CRO whose Legal Services group was led by Triclinic CSO David Bugay. Now integrated into Eurofins; shared employee alumni base and overlapping solid-state and IP consulting offerings.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/SolidStateDev
• Facebookfacebook.com/people/Triclinic-Labs-Inc/100057378793478
• LinkedInlinkedin.com/company/triclinic-labs

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds

Investors

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 →

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