Name

Comecer

Legal name

Comecer S.p.A.

Website

https://comecer.com

Company type

Private

Founded year

1975

Operating status

Operating

Headcount range

501–1,000 employees

Ownership category

akta.pro rank

Product category

Pharmaceutical Aseptic Processing Equipment

NAICS

Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (33451)

SIC

Surgical & Medical Instruments & Apparatus (3841), General Industrial Machinery & Equipment (3560), Laboratory Analytical Instruments (3826)

akta.pro primary industry

Aseptic Processing, Fill-Finish & Sterile Manufacturing Tech (isolators, lyophilization interfaces) (HLAAAJAG)

akta.pro secondary industries

Drug Product Fill-Finish & Aseptic Manufacturing Services (HLAAAKAB), Radiopharmaceutical CDMO & Manufacturing (GMP Fill-Finish) (HLAIAGAF), Fill-Finish & Aseptic Drug Product Manufacturing (Biologics/ATMP) (HLAGAGAG)

Keywords

• Aseptic processing equipment
• Radiopharma containment systems
• Pharmaceutical fill-finish
• Cell gene therapy isolators
• Radiation shielding equipment

Headquarters

HQ city

Ravenna

HQ country

Italy

HQ region

Europe

Offices6 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Equipment Sales: Sale of specialized aseptic processing and containment equipment including hot cells, isolators, dispensing systems, filling machines, and shielding solutions for radiopharma, pharma, and ATMP applications. Equipment sales represent the primary revenue stream with custom-configured systems for specific customer requirements.
2. Service & Maintenance: Aftermarket service including installation, validation, calibration, spare parts, and preventive maintenance for installed equipment base worldwide.
3. Validation & Qualification Services: Comprehensive validation services including FAT, SAT, IQ, OQ, PQ, cycle development, and SMEPAC testing for regulatory compliance.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels8 records

Core offering

Comecer designs, develops, and manufactures specialized aseptic processing and containment equipment for the radiopharma, pharmaceutical, and ATMP (Cell & Gene Therapy) sectors. Its core product lines include shielded hot cells, radiochemistry systems, aseptic and containment isolators, robotic dispensing systems, and integrated robotic fill-finish lines, sold alongside proprietary IoT production management and nuclear medicine workflow software.

Product overview

Comecer offers a comprehensive portfolio of innovative aseptic processing and containment systems organized into three main divisions: Radiopharma (including GMP Radiopharmacy, Nuclear Medicine, and Industrial Projects), Pharma (including Containment, Fill & Finish, and Aseptic solutions), and ATMP Cell & Gene Therapy (including Cell Culturing Isolators, Incubation Systems, and Cell Filling Systems). The core product lines include robotic dispensing systems (THEODORICO 2, MIKROS, MODUS), high-throughput aseptic isolators (HELIOS, PHAEDRA), and advanced filling solutions (FLEXLINE Series, MICROLINE Series, MACROLINE Series). The ATMP portfolio features modular isolator platforms (ValueCell COMBI, SOLO, FLEXY) and incubation systems (FlexyCult). Supporting software includes Illuminate for IoT production management and Nuclear Medicine Software (IBC) for workflow control. The portfolio is complemented by a complete range of radiopharma accessories including shielded containers, dose calibrators, and environmental monitoring systems. All products are supported by service offerings including validation, maintenance, and digital solutions.

Differentiator

Problem solved

Functional benefit

Brands

• Illuminate: Pharma and Radiopharma IoT production management software for single isolators and complex production lines.
• FLEXLINE
• MICROLINE
• ValueCell
• IBC RP
• IBC NM
• VaxISO
• Speedy Glove
• Always On

Products and services

• THEODORICO 2 Robotic dispenser for radiopharmaceuticals designed for automated dosing in nuclear medicine applications.
• HELIOS High-throughput aseptic isolator for vials and syringes filling, designed for GMP-compliant radiopharmaceutical production.
• PHAEDRA Radiopharmaceutical dispensing isolator for vials and syringes designed for aseptic preparation in nuclear medicine.
• FLEXLINE Series Robotic aseptic filling and closing systems for Ready-To-Use (RTU) vials, syringes, and cartridges in clinical to small-scale production, integrated with isolator technology.
• FLEXLINE RF-ST Robotic aseptic filling and closing system for RTU containers powered by SuperTrak CONVEYANCE, designed for sterile pharmaceutical production.
• MICROLINE Series Rotary aseptic filling and closing systems for vials and syringes in clinical and early-stage production.
• ValueCell COMBI Cell & Gene Therapy modular isolator designed for scalable ATMP manufacturing with flexible configuration options.
• ValueCell SOLO Stand-alone Cell & Gene Therapy isolator for independent aseptic processing in ATMP applications.
• ValueCell FILL Semi-automatic and refrigerated bag aseptic filling system for Cell & Gene applications.
• FlexyCult Incubation system for advanced therapy labs designed for cell culture and gene therapy manufacturing.
• Illuminate Manufacturing Intelligence Pharma and Radiopharma IoT production management software for single isolators and complex production lines, providing manufacturing intelligence and workflow optimization with FDA 21 CFR Part 11 compliance.
• Nuclear Medicine Management Software (IBC) Management software for radio-pharma, PET departments, PET cyclotron facilities, and nuclear medicine departments for optimal workflow management and quality control.
• THERADOSE Theranostic injector for single-dose vials designed for diagnostic and therapeutic nuclear medicine procedures.
• MIKROS Micro-dispenser for Lu-177 and Ac-225 radiopharmaceuticals designed for precise dosing of therapeutic radionuclides.
• MODUS Modular dispensing system for back-to-back production enabling continuous radiopharmaceutical manufacturing.
• Speedy Glove Automatic portable glove integrity tester for validation and routine testing of isolation systems.
• VaxISO Upstream Isolator Dedicated stand-alone isolator for vaccine research and final formulation.
• Quality Control & Visual Inspection Hot Cells Automatic hot cell and stand-alone modules for radiopharmacy production quality control and visual inspection.
• SmartGuard Environmental Radiation Monitoring System Continuous environmental radiation monitoring system for radiopharmacy facilities, providing real-time radiation level detection and alarms.
• BBS Series Shielded Cells Shielded cells for synthesis modules providing radiation protection for radiopharmaceutical synthesis operations.
• BBST Series Shielded Isolators Shielded isolators for dispensing radiopharmaceuticals with integrated radiation protection.
• MUSA 68Ga Shielded Isolator Shielded isolator for Gallium-68 synthesis and dispensing designed specifically for Ga-68 radiopharmaceutical production.
• PAPI Potent API Processing Isolator Potent API processing isolator designed for handling highly active pharmaceutical ingredients with operator protection.
• IVY Series Sterile IV Bags Filling and Closing Machine Linear sterile filling and closing system for IV bags in format-flexible pharmaceutical production.
• RW-250 Rotary Intermittent Washing Machine Rotary intermittent washing machine for stand-alone applications for glass vials, bottles, and containers in pharmaceutical production.
• TSL Depyrogenation Tunnel Depyrogenation tunnel for thermal depyrogenation of glass containers in pharmaceutical production.
• FLEXLABEL Labeling Machine and Rod Inserter Advanced downstream labeling and rod insertion solution for syringes in automated pharmaceutical production lines.
• Service & Maintenance Solutions Aftermarket service including installation, validation, calibration, spare parts, and preventive maintenance for installed equipment base worldwide.
• Validation & Qualification Services Comprehensive validation services including FAT, SAT, IQ, OQ, PQ, cycle development, and SMEPAC testing for regulatory compliance.
• Disposable Kits for Pharmaceutical Production Single-use disposable kits for use with Comecer's processing and containment equipment in pharmaceutical production.

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

One partnership is on record.

• ATS Life Sciences GroupcoreOthersComecer is a member of the ATS Life Sciences Group, a global company providing manufacturing solutions for the life sciences industry. ATS Life Sciences Group is part of ATS Corporation, providing Comecer with corporate backing, shared resources, and operational integration within a larger manufacturing technology organization. The relationship provides Comecer access to global scale while maintaining its specialized focus on aseptic processing and containment systems.

Scale indicators2 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• SKAN: Swiss specialist in aseptic and containment isolators for pharmaceutical and biopharmaceutical manufacturing. Highly comparable to Comecer's Pharma isolator portfolio, particularly VaxISO and PAPI product lines.
• Tema Sinergie: Italian manufacturer of aseptic isolators and containment systems for pharma and hospital pharmacy. Overlaps directly with Comecer's Containment, Aseptic, and Hospital Pharmacy segments in Europe.
• Trasis: Belgian developer of radiopharma dispensing and synthesis equipment, including modules for Ga-68 and Lu-177. Directly competes with Comecer's THEODORICO, MIKROS, and BBS/MUSA shielded-cell lines.
• IBA (Ion Beam Applications): Belgian company with a radiopharma solutions business that supplies shielding, hot cells, and dispensing systems to nuclear medicine and PET facilities. Closely comparable to Comecer's Radiopharma division offering.
• Von Gahlen: Dutch manufacturer of shielded cells, radiopharma isolators, and nuclear medicine accessories. Highly comparable to Comecer's BBS, BBST, MUSA, and SmartGuard shielding/monitoring product family.
• LabLogic Systems: UK-based specialist in radiopharmacy QC instrumentation, dose calibrators, and chromatography systems. Comparable to Comecer's radiopharma accessories and measurement/process control offering.
• Germfree Laboratories: US manufacturer of containment isolators, barrier systems, and cleanroom equipment for pharmacy, ATMP, and biopharma customers. Direct competitor to Comecer's containment and ATMP isolator lines, particularly in North America.

Broad incumbents

• Steris: Global leader in sterilization, infection prevention, and aseptic processing equipment for pharma and medical device customers. Broader portfolio than Comecer but overlaps in sterile fill-finish and containment.
• Getinge: Swedish medtech/life-science conglomerate offering sterilizers, isolators, and pharmaceutical processing equipment. Competes with Comecer in aseptic processing but serves a much wider customer base.
• Cytiva (Danaher): Global life-sciences equipment and bioprocessing supplier covering upstream/downstream, fill-finish, and ATMP manufacturing. Provides broader scope than Comecer but overlaps in sterile fill-finish and cell therapy workflows.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/ComecerGroup
• YouTubeyoutube.com/user/comecerspa
• Facebookfacebook.com/Comecer
• LinkedInlinkedin.com/company/comecergroup
• Instagraminstagram.com/comecergroup

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds2 records

Investors2 records

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

M&A2 records

Investments

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

Frequently asked questions about Comecer