What Prolytix does

Prolytix is a privately held, U.S.-based bioanalytical Contract Research Organization (CRO) operating from Essex Junction, Vermont, focused exclusively on large molecule (biologics) drug development. Founded in 1987 as Haematologic Technologies by thrombosis and hemostasis scientist Kenneth Mann and rebranded to Prolytix in March 2022, the company provides assay development, validation, and release testing across protein therapeutics, coagulation and hematology therapies, plasma-derived products, and cell/gene therapies, operating in integrated GLP, GCP, CLIA, and GMP facilities certified to ISO 9001:2015. Its service portfolio spans PK/PD assays, immunogenicity (anti-drug antibody) testing, biomarker assays, GMP stability and release testing, host cell protein analysis using both ELISA and high-resolution mass spectrometry, and bioanalytical support for monoclonal antibodies, bispecifics, recombinant proteins, vaccines, and viral vectors.

The company monetizes primarily through statement-of-work-based CRO services billed at quoted per-project and hourly out-of-scope rates (Net 30 terms), supplemented by product revenue from a research-reagent catalog of 150+ blood coagulation products (plasma proteins, antibodies, deficient plasmas, custom IVD/POC reagents) and Custom Collection Devices (custom-formulated blood collection tubes) developed jointly with Greiner Bio-One. Reagent products are sold direct via the company's e-commerce storefront with bill-and-hold terms, while services engage via high-touch enterprise field sales with senior scientific staff embedded in client collaboration. Proprietary assets include the PROPath real-time project tracker, a mixed-mode HPLC method for polysorbate detection, a novel plasma fractionation technique for IgG, HRMS-based HCP workflows, and 60 validated thrombosis and hemostasis assays acquired from the Hemostasis Reference Laboratory in January 2026. The company sells primarily to biotech and biopharma developers of large molecule therapeutics, with >90% of new clients signing for a second project and 100% on-time delivery cited as core differentiators versus larger global CROs. Distribution and customer engagement are direct (phone, contact form, conference booths at ISTH/AAPS/ADLM/PPTA) with no channel partners or resellers.

The company has been PE-controlled since October 2019 under Edgewater Capital Partners, a Cleveland-based lower middle-market private equity firm focused on performance materials and life sciences. Governance includes CEO David Sunseri, Ph.D., COO Ryan Dorfman, Ph.D., and CFO Robert Weisman, with strategy centered on scaling the biologics CRO platform via organic capability expansion, bolt-on acquisitions (e.g., the HRL assay purchase, the Allumiqs multiomics partnership of March 2024), and entry into adjacent modalities such as cell and gene therapy and AI model validation.

Name

Prolytix

Legal name

Haematologic Technologies, LLC

Website

https://www.goprolytix.com/

Company type

Private

Founded year

1987

Operating status

Operating

Headcount range

11–50 employees

Short description

Prolytix is a U.S.-based, PE-owned bioanalytical CRO providing GLP/GCP/CLIA/GMP-compliant assay development, validation, and release testing for biotech and biopharma companies developing large molecule therapeutics, coagulation/hematology products, plasma-derived therapies, and cell/gene therapies.

Ownership category

akta.pro rank

Product category

Bioanalytical Contract Research Services for Biopharmaceuticals

NAICS

Medical Laboratories (621511), In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

akta.pro secondary industries

Cell-Based & Potency Assays (Bioassays) (HLAGADAH), Proteomics & Mass Spectrometry Services (HLAGANAB)

Keywords

• Bioanalytical testing services
• Contract research organization
• Protein characterization services
• GMP release testing
• Host cell protein analysis

Headquarters

HQ city

Essex Junction

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. Bioanalytical CRO Services (Contract Research): Fee-for-service contract research organized by statement of work, quoted per project, billed at hourly rates for work outside standard scope. Services span GLP/GCP/CLIA/GMP assay development, validation, stability testing, release testing, and bioanalytical testing. Represents the core revenue stream.
2. GMP Stability Testing & Storage: GMP-compliant stability testing and storage services for drug substance and drug product, supporting ICH-compliant programs and shelf-life determination.
3. GMP Release Testing: GMP release testing for bulk, final product, and in-process materials with pre-defined release protocols.
4. Research Reagent and Custom Product Sales: Sale of high-quality research reagents (plasma proteins, antibodies, inhibitors, substrates, deficient plasmas), custom IVD/POC reagents, and customized blood collection tubes. Subject to bill-and-hold arrangements. Courier expenses invoiced as pass-through plus 15%.
5. Custom Collection Devices: Custom-designed and manufactured blood collection tubes and sample preservation devices for clinical trials and novel diagnostics, available in small pilot batches through large-scale GMP production.
6. Critical Reagent Manufacturing: Manufacturing of custom critical reagents for biotherapeutic development programs.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels7 records

Core offering

Prolytix is a bioanalytical Contract Research Organization that provides GLP, GCP, CLIA, and GMP compliant assay development, validation, stability testing, and release testing services for large molecule therapeutics including monoclonal antibodies, bispecifics, recombinant proteins, plasma-derived therapies, gene therapies, and vaccines. The company also manufactures and sells custom blood collection devices, critical reagents, and high-quality research reagents for biotech and biopharma clients.

Product overview

Prolytix is a bioanalytical Contract Research Organization (CRO) offering integrated services for large molecule biotherapeutic development. The portfolio includes drug modality-focused bioanalytical services (Coagulation & Hematology, Protein Based Therapeutics, Plasma-Derived Therapies, Food Allergens), regulatory-compliant testing services (GLP/GCP/CLIA/GMP), characterization and development services, proprietary PROPath project tracking software, and research reagent products. Solutions span Cell and Gene Therapies, Monoclonal & Polyclonal Antibodies, Vaccines and Viral Vectors, Recombinant Proteins, and Plasma-Based Proteins. Custom Collection Devices and Critical Reagent Manufacturing support clinical trials and diagnostic development. The company operates from 57 River Road in Essex Junction, VT, with over 35 years of protein chemistry expertise.

Differentiator

Problem solved

Functional benefit

Brands

• PROPath: Real-time project tracker software for project management
• Haematologic Technologies

Products and services

• Coagulation & Hematology Bioanalytical Services Comprehensive bioanalytical testing services for hemophilia A and B, hemophilia C (Factor XI deficiency), von Willebrand Disease, direct oral anti-coagulants (DOACs), thrombin generation assays, platelet aggregation, and hemostatic risk evaluation for plasma-derived products, designed for biotech and biopharma developers of coagulation and hematology therapeutics.
• Protein-Based Therapeutics Bioanalytical Services Bioanalytical assay development and validation services for monoclonal antibodies, bi- and tri-specific proteins, recombinant proteins, enzyme replacement therapies, and biosimilars, supporting biotech and biopharma developers of large molecule protein therapeutics from discovery through commercialization.
• Plasma-Derived Therapies Bioanalytical Services Bioanalytical services for plasma fractionation and biotherapeutic development, including IVIG therapeutics, clotting factor analysis, and plasma protein characterization for plasma-derived therapy developers.
• GLP, GCP & CLIA Services Regulatory-compliant bioanalytical testing services delivered under GLP, GCP, and CLIA frameworks, including pharmacokinetics assays, immunogenicity (anti-drug antibody) assays, biomarker assays, and hemostasis and coagulation assays and platforms.
• GMP Services (Stability Testing & Release Testing) GMP-compliant stability testing and storage and release testing for bulk, final product, and in-process materials, supporting ICH-compliant programs and shelf-life determination for large molecule biopharmaceuticals.
• Characterization & Development Services Method development, process development, protein characterization, and host cell protein analysis services for biotherapeutic development, leveraging high-resolution mass spectrometry (HRMS) alongside ELISA for comprehensive HCP identification and risk assessment.
• PROPath Real-Time Project Tracker Proprietary real-time project management software that provides clients transparent access to project milestones, enabling faster decision-making and supporting highly effective program management with on-time delivery.
• Analytical Validation of AI Models Service offering for analytical validation of AI models, bridging in silico predictions with empirical laboratory data for AI-driven biotech companies developing large molecule therapeutics.
• Custom Collection Devices (CCD) Custom-designed and manufactured blood collection tubes and sample preservation devices for clinical trials and novel diagnostics, available in small pilot batches through large-scale GMP production via partnership with Greiner Bio-One.
• Critical Reagent Manufacturing Manufacturing of custom critical reagents, including plasma proteins, antibodies, and custom IVD/POC device reagents for research and diagnostic applications.
• High-Quality Research Reagents (Shop Products) Off-the-shelf and custom research reagents including coagulation proteins, antibodies, inhibitors, substrates, deficient plasmas, and custom IVD/POC reagents, sold directly through the Prolytix website storefront.

Quantifiable outcome

• >90% of new clients sign for a second bioanalytical services project
• +3 more outcomes

Named customers3 records

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature9 records

Partnerships

Two partnerships are on record, tiered core.

• AllumiqscoreStrategic or Co-development Partner · 11 March 2024Long-term strategic partnership focused on delivering integrated solutions to help customers optimize drug development pipelines. Allumiqs brings multiomics and LC-MS/MS expertise in early R&D phases (mechanism of action, biomarker identification, drug product characteristics), while Prolytix provides complementary targeted method development for stability, potency, and GMP release testing. Together they offer interconnected solutions and blended expert teams, reducing risks and complications of transferring R&D work between vendors. The partnership was formalized after several successful joint customer engagements.
• Greiner Bio-OnecoreStrategic or Co-development Partner · 20 August 2020Collaboration to provide end-to-end development and custom manufacturing of blood collection tubes for IVD and clinical diagnostic device developers. HTI (now Prolytix) contributes pilot-scale and small-to-medium batch customized blood collection tube production, while Greiner Bio-One contributes GMP-level high-volume batch manufacturing. The partnership creates a vertically integrated solution spanning early development to large-scale commercial production, enabling IVD developers to engage a single group rather than multiple vendors. HTI has sourced empty tubes and caps from Greiner Bio-One for many years prior to the formal collaboration.

Scale indicators8 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• BioAgilytix Labs: BioAgilytix is a bioanalytical CRO specializing in large molecule biologics, immunoassays (PK, ADA, biomarker), and cell-based assays for biotech and pharma. Most directly comparable to Prolytix by therapeutic focus, assay types, and customer segment.
• KCAS Bioanalytical: KCAS is a bioanalytical CRO focused on large molecule bioanalysis using LC-MS/MS, immunoassays, and biomarker services for biopharmaceutical clients. Similar size and modality mix, with overlapping capabilities in protein therapeutic characterization.
• Celerion: Celerion is a clinical bioanalytical and early-phase CRO offering bioanalytical assay development, validation, and sample analysis for small and large molecules. Overlaps with Prolytix on regulated bioanalytical services for biopharma.
• Frontage Laboratories: Frontage provides bioanalytical, CMC, and clinical laboratory services to biopharmaceutical companies, with significant large molecule bioanalysis and GMP release testing capabilities directly comparable to Prolytix's service portfolio.
• Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-sized CRO providing bioanalytical and clinical pharmacology services with strong capabilities in immunoassay and LC-MS/MS bioanalysis for biologics and complex therapeutics. Comparable in scale and scientific depth.

Broad incumbents

• Charles River Laboratories: Charles River is a global, publicly-traded CRO offering bioanalytical, safety, and manufacturing services including large molecule and biologics support. Significantly larger than Prolytix and serves the same biotech/biopharma customer base with broader portfolio.
• Labcorp Drug Development: Labcorp (including the former Covance) operates one of the largest global CRO and central lab networks, providing bioanalytical, biomarker, and clinical trial lab services. Competes with Prolytix for large molecule bioanalytical contracts from pharma/biotech.
• IQVIA: IQVIA is the world's largest CRO with extensive bioanalytical laboratory capabilities supporting biologics and complex therapeutic development. Competes with Prolytix at the high end of large molecule bioanalytical services.
• Eurofins Scientific: Eurofins operates a global network of bioanalytical and pharmaceutical testing laboratories, including specialty large molecule and biologics testing services. Overlaps with Prolytix across protein characterization, HCP, and release testing.
• Thermo Fisher Scientific (PPD): Thermo Fisher's PPD clinical research business provides global bioanalytical and biologics testing services as part of its integrated CRO offering. Comparable to Prolytix in large molecule bioanalysis but operates at materially greater scale.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 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 →

Frequently asked questions about Prolytix