What GMPTEC does

GMPTEC GmbH is a German (Gronau, Lower Saxony) supplier of GMP-compliant single-use and multi-use components and systems used in the production of pharmaceuticals, diagnostics, high-value foods, and chemicals, with the majority of its technology applied in biotechnology (cell culture, upstream/downstream processing, purification, and cell and gene therapy). Founded in 2013, it is a privately held limited-liability company (GmbH) with 11-50 employees, led by co-managing directors Marco John and Dominic Marx. Its product surface spans single-use assemblies (bag, bottle, and tubing assemblies), connection systems (MicroCNX, AseptiQuik, MPC/MPX couplings), filtration (ultrafiltration, sterile filtration, TFF), process components (pumps, valves, sensors), and proprietary/sub-brand lines including CELLGTEC (metal cassettes for cryogenic storage to -85°C) and the distributed Entegris Aramus fluoropolymer freeze bags.

The company positions itself as a "one-stop-shop," combining resale of partner-manufactured components (CPC, Entegris, and others) with in-house custom assembly design and manufacturing in an ISO Class 7 cleanroom. Products ship with material certificates, validation documentation, and Extractable/Leachable studies, and batch-specific certificates of conformity referencing FDA CFR 177.1520, USP Class VI <88>, and BSE/TSE statements. Value-added cleanroom services include cleaning, repackaging, kit assembly, labeling, gamma irradiation, laser engraving, and precision tube cutting. Its quality system is certified to ISO 9001:2015 and it is an EcoVadis network member.

The business model is B2B, sales-led, and consultative rather than e-commerce: customers request quotes via inquiry form, phone, or email, and GMPTEC offers free, non-binding custom assembly development from initial sketch to technical drawing and quotation. Revenue is generated through hardware sales of GMP components/assemblies, custom assembly design-and-manufacture (professional services), and cleanroom value-added services, with low minimum order quantities (typically 10 units or fewer). Pricing is not publicly disclosed. Go-to-market relies on direct sales, industry trade shows (e.g., Single-Use Event Basel, GMP-PharmaCongress & GMP-PharmaTechnica Wiesbaden), and its bilingual website.

Name

GMPTEC

Legal name

GMPTEC GmbH

Website

https://gmptec.de

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

11–50 employees

Short description

GMPTEC is a German B2B supplier of GMP-compliant single-use and multi-use components, custom assemblies, and ISO Class 7 cleanroom services for pharmaceutical, biotech, diagnostics, food, and chemical production, including cell and gene therapy applications.

Ownership category

akta.pro rank

Product category

Pharmaceutical & Biotech Single-Use Components

NAICS

Commercial and Service Industry Machinery Manufacturing (333310)

SIC

General Industrial Machinery & Equipment (3560)

akta.pro primary industry

Single-Use Systems Assembly & Consumables Manufacturing (Bags/Tubing/Assemblies) (HLAGAGAH)

akta.pro secondary industries

GMP Manufacturing Support Services (QA/QMS, validation, documentation) (HLAAAKAH), GMP Quality, Validation & Regulatory Support (GMP/CSV/Qualification) (HLAGAGAL)

Keywords

• Single-use assemblies
• GMP-compliant components
• Pharmaceutical filtration systems
• Sterile connectors
• Cleanroom services

Headquarters

HQ city

Gronau

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Personnel, Infrastructure, Operations, Marketing or Sales

Revenue model

1. GMP Components and Systems Sales: Sale of pharmaceutical-grade components including single-use assemblies, tubing, fittings, connectors, bottles, bags, and filtration equipment. Products are sold with material certificates, validation documentation, and Extractable/Leachable studies. Batch-specific certificates of conformity include FDA CFR 177.1520, USP Class VI <88> compliance, and BSE/TSE statements.
2. Custom Assembly Development and Manufacturing: Custom Single-Use Assembly design and manufacturing services. The company offers free consultation and design services from initial sketch to technical drawing and quotation. Assemblies are manufactured to customer specifications and can include various connection types, tubing materials, filters, and connectors.
3. Cleanroom Services: Value-added services including cleaning in cleanroom, repackaging, kit assembly, labeling, gamma irradiation, laser engraving, and tube cutting performed in ISO-certified cleanroom environment.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels3 records

Core offering

GMPTEC manufactures and supplies GMP-compliant single-use and multi-use components and systems for pharmaceutical, biotech, diagnostic, food, and chemical production. It sells standard components (tubing, bags, bottles, connectors, filters) and custom-configured Single-Use Assemblies produced in-house in an ISO Class 7 cleanroom, along with value-added cleanroom services and free custom-assembly development.

Product overview

GMPTEC GmbH is a German pharmaceutical and biotech equipment supplier offering a comprehensive portfolio of GMP-compliant single-use and multi-use products and assemblies. The core offering centers on Single-Use Assemblies as ready-to-use systems for pharmaceutical production, complemented by specialized product lines including CELLGTEC Shell (metal cassettes for cryogenic storage), Aramus Freeze Bags (fluoropolymer freeze bags), and various bag/bottle/tubing assemblies. The product ecosystem spans connection components (MicroCNX, AseptiQuik, MPC/MPX couplings), process equipment (pumps, valves, sensors), filtration solutions (ultrafiltration, sterile filtration, TFF), and cleanroom services. The company provides both standard components and fully customized assembly solutions, supported by an ISO Class 7 cleanroom for manufacturing and additional value-added services.

Differentiator

Problem solved

Functional benefit

Brands

• CELLGTEC: Metal cassette product line for safe storage and transport of pharmaceutical ingredient bags, including CELLGTEC Shell and CELLGTEC Rack
• Aramus Freeze Bag

Products and services

• CELLGTEC Shell Innovative reusable stainless steel and aluminum metal cassette for safe storage and transport of pharmaceutical active ingredient bags used in cell and gene therapy, supporting bag sizes from 5ml to 2 liters and temperatures down to -85°C and below.
• Aramus Freeze Bag Gamma-sterilizable freeze bags made from fluoropolymer material designed for freezing applications down to -85°C for cells and pharmaceutical ingredients, used in cell and gene therapy applications.
• Beutel-Assemblies (Bag Assemblies) Single-use bag assemblies in 2D and 3D formats up to 4000L, including medium bags, sampling bags, filter bags, reactor bags, buffer bags, and mixing bags for pharmaceutical and biotech processes.
• Flaschen-Assemblies (Bottle Assemblies) Individually configurable single-use plastic bottles equipped with tubing and additional components for safe sample withdrawal within closed systems.
• Schlauch-Assemblies (Tubing Assemblies) Sterilized ready-to-use tubing systems for GMP-compliant pharmaceutical and biotech processes, available in autoclaveable or gamma-irradiated versions, with low minimum order quantities.
• Single-Use-Assemblies Ready-to-use single-use assembly systems for pharmaceutical manufacturing, available in Ready-To-Use (gamma-sterilized) and Ready-To-Autoclave versions, combining tubing, bags, bottles, filters and connectors, manufactured in ISO Class 7 cleanroom.
• Tri-Clamp Klammer aus Kunststoff Glass fiber-reinforced nylon tri-clamp clamps for securing tri-clamp connections, USP Class VI and FDA compliant, gamma-sterilizable.
• PharmaLok Schlauchklemmen Tubing clamps for controlling flow in tubing lines, featuring robust design, high pressure resistance up to 10 bar, and temperature range from -70°C to +60°C.
• MicroCNX Sterilkonnektoren Sterile connectors from CPC for aseptic connection of small-diameter tubing (1.6mm to 3.2mm ID), designed for biopharmaceutical processing and cell and gene therapies.
• MPC/MPX Schnellkupplungen Ergonomic quick couplings with tubing connections for fast, leak-free fluid transfer, available in polysulfone and polycarbonate materials.
• AseptiQuik Sterilkupplungen S, G & L Sterile couplers enabling sterile connections outside sterile environments with genderless design, available in three series for different flow rates and tubing sizes.
• Ultrafiltrationslösungen (Ultrafiltration Solutions) Ultrafiltration filters with flexible membrane materials (PES, PVDF, PTFE), 100% integrity testing, and customizable filter size and connections.
• TFF Equipment (Tangential Flow Filtration) Tangential Flow Filtration equipment and components for gentle and efficient biopharmaceutical processing from development to production scale.
• Anlagenkomponenten (Plant Components) Plant components for cGMP processes including process valves, safety valves, piston diaphragm pumps, tube pinch valves, and sight glasses.
• Coriolis Single-Use Sensoren Coriolis mass flow sensors for single-use applications enabling high-accuracy flow measurement in bioprocessing.
• Reinraum Services (Cleanroom Services) Cleanroom services including cleaning, repackaging, kit assembly, labeling, gamma irradiation, laser engraving, and custom tube cutting performed in ISO Class 7 certified cleanroom.
• Custom Single-Use Assembly Development Free, non-binding custom assembly design and engineering service from initial sketch to technical drawing and quotation, developing individual assemblies to customer specifications.

Quantifiable outcome

• Reduced validation effort through pre-validated components and assemblies
• +1 more outcomes

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

Four partnerships are on record, tiered core.

• Simtra BioPharma SolutionscoreStrategic or Co-development Partner · 1 June 2026GMPTEC collaborated with Simtra BioPharma Solutions and other project partners on the development of PUPSIT (Pressure Integrity Test) systems. GMPTEC contributed custom single-use solutions specifically designed for the demanding process requirements of this innovative sterile manufacturing system.
• Flow Test GmbHcoreStrategic or Co-development Partner · 16 October 2025Joint presence at trade shows including GMP-PharmaCongress & GMP-PharmaTechnica in Wiesbaden. Flow Test provides filter integrity testing equipment that complements GMPTEC's single-use systems, offering integrated solutions for pharmaceutical manufacturing.
• CPC (Colder Products Company)coreTechnology or IntegrationCPC is a manufacturer of quick couplings and sterile connectors. GMPTEC offers CPC products including MPC/MPX quick couplings, AseptiQuik sterile couplers, and MicroCNX sterile connectors as part of their assembly solutions.
• EntegriscoreTechnology or IntegrationEntegris manufactures Aramus Freeze Bags - the only gamma-sterilizable bags made from fluoropolymer material. GMPTEC distributes these products as part of their single-use solutions portfolio for freeze applications down to -85°C.

Scale indicators4 records

Recent moves8 records

Expansion highlights6 records

Broad incumbents

• Merck KGaA (MilliporeSigma Life Science): Offers Mobicon single-use systems, Mobius assemblies, and validated filtration for biomanufacturing. A broad incumbent competing with GMPTEC across the single-use and sterile filtration portfolio.
• Cytiva (Danaher): Supplies single-use systems, filtration, and fluid management components to biopharma manufacturers (ReadyToProcess bags, ÄKTA platforms). A broad incumbent in the same biomanufacturing component category GMPTEC serves.
• Sartorius AG: Major biopharma equipment and single-use solutions provider (Flexsafe bags, integrated platforms). Competes in the same downstream single-use assembly space with stronger brand recognition, multi-site manufacturing, and validated proprietary platforms.
• Thermo Fisher Scientific (Single-Use & Bioproduction): Global bioproduction leader offering proprietary single-use systems (e.g., HyClone, Nunc) and bioprocessing consumables. Directly overlaps GMPTEC's single-use assembly and filtration offering but at vastly larger scale with worldwide service infrastructure.
• Parker Hannifin (Bioscience Division / SciLog): Provides single-use sensors, filtration, and fluid handling components for bioprocessing. Overlaps with GMPTEC's sensor (Coriolis), tubing, and filtration offerings as part of a much larger industrial portfolio.

Direct peers

• Colder Products Company (CPC): Manufacturer of sterile quick-disconnect couplings (AseptiQuik, MicroCNX, MPC/MPX) — the same components GMPTEC integrates into its assemblies. CPC is both a supplier (via GMPTEC's portfolio) and overlapping competitor for sterile connection solutions.
• Repligen Corporation: Provides bioprocessing components including single-use flow assemblies, filtration, and chromatography solutions. Comparable mid-size competitor focused on biopharma fluid management with strong regulatory documentation similar to GMPTEC.
• Saint-Gobain Life Sciences: Designs and manufactures custom single-use assemblies and fluid handling components (tubing, bags, connectors) for biopharma. Closest direct competitor in custom-configured single-use assemblies for GMP applications.
• Foxx Life Sciences: Supplies single-use bioprocess containers, tubing assemblies, and filtration to pharma and biotech — a smaller, custom-focused peer closely comparable to GMPTEC's niche of configurable assembly solutions.
• Entegris: Manufactures fluid handling and single-use bioprocessing components, including the Aramus Freeze Bag line GMPTEC distributes. Entegris is both a direct competitor (single-use assemblies) and a key supply partner to GMPTEC.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/GMPTEC
• LinkedInlinkedin.com/company/gmptec

Compliance17 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 →

Frequently asked questions about GMPTEC