Radiopharma
Pharma
ATMP Cell & Gene Therapy
Services
Production management system for both single isolators and complex production lines »
Today, Comecer proudly holds a well-established position as a “radiochemical specialist” on both national and international levels. This significant business growth can largely be attributed to our ongoing product development, combined with a relentless pursuit of advanced technological solutions designed to meet our customers’ most sophisticated needs.
The company employs over 500 people and is led by President & Managing Director Mr. Simone Volpi.
In FY 2023, Comecer achieved an annual turnover of approximately 98 million euros. Around 55% of its sales come from the radiopharmaceutical equipment market, where the company’s specialized shielding systems are used in the production, management, and distribution of radiopharmaceuticals for the diagnosis and treatment of various diseases, including cancer, and cardiovascular disorders. The remainder of sales comes from equipment used in aseptic processing and packaging of specialized pharmaceutical products, as well as from the production of isolators and incubators for Advanced Therapy Medicinal Products (ATMP) and regenerative cell therapies, which involve using patient cells to grow new tissue.
At Comecer, all production processes and products are entirely developed in-house. From analysis and project development to the creation and installation of mechanical, electrical components, and software: every step is executed by our dedicated in-house team. We maintain full control over every phase: design, manufacturing, testing, delivery, and installation. Consequently, several departments are involved in the continuous technological advancement of our offerings in radiochemistry, nuclear medicine, isolation technology, and decommissioning, including Research and Development, Technical Office, Production (including Assembly and Steel Structural Work), Quality Assurance, Quality Control, and the Sales Department.
The ability to create customized solutions for its clients is at the basis of Comecer’s success. Operating in industries where every customer has unique needs means that standard solutions are often not sufficient. This is why, at Comecer, every new project begins with listening to the customer’s specific requirements. A dedicated project team thoroughly analyzes and understands the processes and environment, recognizing that no two organizations are identical. This team gathers all relevant data, considers every aspect, and designs tailored solutions. The possible alternatives that best meet the customer’s needs are then presented and discussed. Many customers are surprised by the extent of customization possible and are impressed by Comecer’s proposals.
Comecer oversees its products at every stage, from production to their use in radiopharmaceutical laboratories and nuclear medicine facilities. The company ensures all products are certified, and all systems undergo extensive testing and validation in compliance with national, European, and international regulatory standards. Specifically, Comecer adheres to a code of ethics, called Safety First, which goes beyond the requirements of current legislation, prioritizing personal safety and environmental protection in every company policy and action. This commitment to safety is reflected in the quality of the materials and processes used, enabling Comecer’s products to meet the highest industry standards.
Among the equipment produced by Comecer are cells for handling radioactive substances, automatic systems for distribution into vials or syringes, and complete lines for the production and packaging of radiopharmaceuticals.
The company is currently composed of three major business divisions and operates in the following sectors:
Comecer designs and manufactures systems and equipment for the safe handling of radioactive substances used in nuclear medicine, ensuring minimum exposure to operators, complete decontamination, and stability under all working conditions. Comecer stands out in the field of radiochemistry, where it produces shielding systems for special applications on behalf of major industrial groups and research institutes. Radiopharmaceuticals are radioactive substances used to target specific areas of the body, emitting radio particles that are captured by gamma chambers and PET scanners to provide precise functional and morphological images.
In the nuclear medicine sector, Comecer’s products are utilized in some of the world’s leading research centers, universities, hospitals, and pharmaceutical companies.
Another key sector for Comecer is isolation technology, which focuses on systems designed to reduce or completely eliminate the risk of contamination within a protected environment. Comecer specializes in the customized production of isolators, devices that provide the highest level of separation and protection for handling toxic and/or sterile substances across various industries, including pharmaceutical, chemical, cell culture, food, and aerospace.
The company offers a diverse portfolio that includes both standard products and high-quality customized solutions, thanks to the specialized expertise it has developed over the years. Comecer’s containment solutions range from isolators for handling highly active principles or excipients to multi-stage isolators used in chemical synthesis or laboratory operations. Its aseptic solutions include isolators designed for sterility testing and formulation of sterile drugs, as well as isolators or Restricted Access Barrier Systems (RABs) integrated into filling lines. Comecer’s products are widely recognized and used in hospitals, universities, research centers, pharmaceutical companies, and large industrial groups around the world.
The third business area focuses on equipment for the manipulation and treatment of biological medicinal products, particularly medicinal products for Advanced Therapies (ATMP). Unlike chemically derived drugs, these products require specialized processing equipment and specific environmental conditions to ensure compliance with sector-specific GMP (Good Manufacturing Practices) and pharmaceutical regulations.
To meet these needs, Comecer has developed a system based on isolator technology, where all equipment used adheres to the highest standards and all regulatory requirements. The system is integrated into the main facility, ensuring compliance with Class A environmental certification. It can be centrally controlled by a single operator, is modular and flexible, and optimized space utilization while achieving high ergonomic and performance standards.
