HiTech Health

What HiTech Health does

HiTech Health is an Irish Contract Development and Manufacturing Organisation (CDMO) specialising in advanced therapy medicinal products (ATMPs), with a focus on cell and gene therapies for clinical and commercial supply. Founded in 2013 and headquartered in Dublin, the company was the first Irish firm licensed to contract-manufacture cell and gene therapies on behalf of international clients, and currently operates two sites in Ireland: a regulatory and operations hub in Dublin and a GMP-certified manufacturing centre in County Galway opened in February 2024. HiTech Health holds Manufacturer's/Importer's Authorisation (MIA) licences from the Irish HPRA (granted January 2020) for both commercial and clinical trial products, and an MHRA MIA for Investigational Medicinal Products in the UK (granted 2025), positioning it as a dual-jurisdiction EU/UK CDMO with in-house Qualified Person teams.

The company's product portfolio spans the full ATMP lifecycle: GMP cell and gene therapy manufacturing, aseptic fill-finish, QC and analytical testing, process development, packaging and labelling, cryogenic storage, cold chain logistics down to ≤-150°C with continuous temperature monitoring, IOR/EOR services, and QP batch certification. It is developing the CellConnect platform in collaboration with the University of Galway and Odyssey Validation Consultants under a €6.58M DTIF grant to capture process data and automate cell manufacturing. Clients disclosed on the company website include Takeda, Ipsen, Jazz Pharmaceuticals, Horizon Therapeutics, Biohaven, Iterum, VascVersa, and NIBRT.

HiTech Health generates revenue through project-based, multi-year CDMO contracts with pharmaceutical, biotechnology, and academic clients, supplemented by professional services in QP batch certification, regulatory consulting, and GDP-compliant supply chain management. The business is privately held, founder-managed under Managing Director Brian Harrison, and has secured over €24M of non-dilutive DTIF public funding across three grants (2021, 2023, 2025) supporting co-development programmes in knee osteoarthritis and Hypoxic Ischemic Encephalopathy cell therapies. GTM is enterprise field sales via a business development team, supported by conference presence at Advanced Therapies Congress, Phacilitate's Advanced Therapies Week, and Advanced Therapies Integrates.

Name

HiTech Health

Legal name

HiTech Health (Déantúsaíocht Sláinte Hitech Teoranta)

Website

https://hitech-health.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

11–50 employees

Short description

HiTech Health is an Irish GMP-certified CDMO specialising in cell and gene therapy manufacturing, QP batch release, and cryogenic cold chain logistics for pharmaceutical, biotechnology, and academic clients across the EU and UK markets.

Ownership category

akta.pro rank

Product category

Cell and Gene Therapy CDMO

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Scientific Research and Development Services (5417)

SIC

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

akta.pro primary industry

Cell Therapy CDMO (HLAGABAD)

akta.pro secondary industries

Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH), Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

Keywords

• Cell therapy CDMO
• Gene therapy manufacturing
• Aseptic fill-finish
• GMP sterile manufacturing
• ATMP contract manufacturing

Headquarters

HQ city

Dublin

HQ country

Ireland

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Development and Manufacturing (CDMO): HiTech Health provides GMP manufacturing services for cell and gene therapies, including process development, analytical testing, and aseptic fill-finish services for clinical and commercial supply. Revenue is generated through project-based contracts with biotech and pharmaceutical companies.
2. Qualified Person (QP) Services: Provides QP batch certification and release services for EU and UK markets under their MIA licences. Services include importation, batch certification, and regulatory compliance support.
3. Quality and Regulatory Consulting: Consulting services covering quality management systems, regulatory compliance, supply chain management, and GDP/GMP support.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

HiTech Health is a Contract Development and Manufacturing Organisation (CDMO) providing GMP-certified development, manufacturing, and supply chain services for advanced therapy medicinal products (ATMPs), including cell and gene therapies. The company offers end-to-end capabilities spanning process development, aseptic fill-finish manufacturing, QC and analytical testing, Qualified Person (QP) batch release for EU and UK markets, and temperature-controlled cold chain logistics with cryogenic storage. Services are delivered from EU GMP-certified facilities in Dublin and County Galway, Ireland.

Product overview

HiTech Health is a Contract Development and Manufacturing Organisation (CDMO) specializing in advanced therapies, specifically cell and gene therapies (ATMPs). The company offers a unified platform of services spanning the entire product lifecycle from development through commercialization. Their core offerings include GMP Cell and Gene Therapy Manufacturing, CDMO Sterile Manufacturing with aseptic fill-finish capabilities, QP Batch Release Services for EU and UK markets, and comprehensive cold chain logistics. These are supported by complementary services including QC/analytical testing, process development, packaging/labelling/storage/distribution, quality assurance, regulatory compliance, and IOR/EOR services. The company operates EU GMP-certified manufacturing facilities in Ireland and holds MIAs in both the EU and UK.

Differentiator

Problem solved

Functional benefit

Products and services

• Contract Development and Manufacturing (CDMO) Services End-to-end contract development and manufacturing services for advanced therapies including cell therapies, gene therapies, and ATMPs, covering development, GMP manufacturing, and global patient supply for pharmaceutical and biotechnology clients.
• GMP Cell and Gene Therapy Manufacturing GMP-certified manufacturing of cell and gene therapy products for clinical and commercial use in EU and UK markets, delivered from HiTech Health's EU GMP-certified facilities in Dublin and County Galway.
• CDMO Sterile Manufacturing - Aseptic Fill-Finish Aseptic fill-finish manufacturing services for sterile formulations including small volume aseptic products, delivered from the County Galway GMP-certified facility.
• QP Batch Release Services (EU and UK) Qualified Person (QP) batch certification and release services for both EU and UK markets, including batch importation certification for both commercial and clinical trial products, delivered by HiTech Health's in-house QP team.
• QC, Analytical Testing and Process Development Quality control testing, analytical method development, and process development services for advanced therapies, supporting both internal manufacturing and third-party clients.
• Packaging, Labelling, Storage and Distribution Packaging, labelling, storage (including cryogenic storage) and distribution services for cell and gene therapies delivered to clinical trial sites across the UK and EU.
• Cold Chain Logistics Services Temperature-controlled transportation and cold chain logistics for cell therapies, including cryopreserved products at ultra-low temperatures (≤-150°C) with validated cryoshippers and continuous temperature monitoring.
• Quality Assurance (QA) Support Quality assurance support services including QA consulting, supplier qualification programs, and quality management system (QMS) generation, implementation, and maintenance.
• Regulatory and Compliance Services Regulatory consulting services to support EMA, FDA, and HPRA approvals, including regulatory strategy and compliance support for advanced therapy developers.
• Importer/Exporter of Record (IOR/EOR) Services Importer of Record and Exporter of Record services for both EU and UK markets, supporting batch importation and supply chain management for advanced therapies.
• Project and Supply Chain Management Project management and supply chain management services for advanced therapy development and commercialisation, coordinating manufacturing, regulatory, and distribution activities.
• Primary Cell Products Primary cell products available for purchase for research and development purposes.

Quantifiable outcome

• Companies can reduce MIA application timeline from 12 months to 3-4 months by partnering with HiTech Health
• +1 more outcomes

Named customers8 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Eleven partnerships are on record, tiered core and minor.

• HAON life sciencescoreStrategic or Co-development Partner · 10 April 2025HAON life sciences leads the CanVas consortium which received €10.7M DTIF grant. HiTech Health facilitates development and GMP manufacture of CanVas-001 therapy for Hypoxic Ischemic Encephalopathy (HIE). The therapy contains ECFC and MSC cell types demonstrating therapeutic benefit in preclinical models.
• NIBRTcoreStrategic or Co-development Partner · 10 April 2025National Institute for Bioprocessing Research and Training (NIBRT) is a key partner in the CanVas consortium, carrying out analytical development for the cell therapy program targeting early brain injury.
• University College Cork Infant Maternal and Child Health Research CentrecoreStrategic or Co-development Partner · 10 April 2025UCC research centre provides clinical development expertise in early brain injury and neonatal HIE as part of the CanVas consortium for cell therapy advancement.
• CCRM AustraliacoreStrategic or Co-development Partner · 30 April 2024Strategic partnership with not-for-profit organisation supporting regenerative medicine commercialisation in Australia. CCRM Australia provides funding opportunities, specialist expertise, and industry connections. HiTech Health provides strategic input for entering EU and UK markets, QP certification, auditing and quality assurance support.
• VascVersacoreStrategic or Co-development Partner · 7 December 2023Partnership with Queen's University Belfast spin-out for development of ANGICYTE cell therapy technology for blood vessel regeneration. HiTech Health committed to developing effective treatments through clinical trials to real-world application.
• University of GalwaycoreStrategic or Co-development Partner · 23 November 2023Awarded €6,579,772 DTIF funding for CellConnect project. University of Galway's Duffy Laboratory leads research on automated cell manufacturing processes and data capture platform.
• Odyssey Validation Consultants LtdminorImplementation/ SI/ Consulting Partner · 23 November 2023Part of CellConnect DTIF consortium providing validation expertise for the automated cell manufacturing platform development.
• Afortiori DevelopmentcoreStrategic or Co-development Partner · 9 November 2023Premier full-service CRO partnership providing integrated suite of services for ATMP and cell and gene therapy clinical trials. Combines clinical trial expertise with HiTech Health's product development and manufacturing capabilities for seamless client support.
• Relevium MedicalcoreStrategic or Co-development Partner · 22 April 2021Awarded €7M DTIF funding for novel Knee Osteoarthritis treatment development. HiTech Health responsible for process development, scale up and GMP manufacturing at Galway facilities.
• Professor Garry Duffy Laboratory at NUI GalwaycoreStrategic or Co-development Partner · 22 April 2021Academic partner in €7M DTIF project for knee osteoarthritis treatment development, providing research expertise in regenerative medicine.
• Anthony NolancoreStrategic or Co-development Partner · 20 April 2021Blood cancer charity collaboration to facilitate development of novel cell and gene therapies. Anthony Nolan provides reliable, scalable source of high-quality starting material (stem cells from 850,000+ donor register and cord blood bank) for R&D and clinical application.

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Market position

Competitive moat6 records

Key highlights7 records

Customer concentration

• Xx.com/HealthHitech
• LinkedInlinkedin.com/company/hitech-health

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 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 HiTech Health