Comecer: high-technology systems for Pharma, Radiopharma and ATMP

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Comecer began in Castel Bolognese, Italy when in the mid-1970s Carlo Zanelli founded Comecer SpA, a small company specializing in nuclear technologies that quickly grew to become a world leader in the field of containment systems for pharma, radiopharma and ATMP.

THE COMPANY

Comecer is an Italian company based in Castel Bolognese (Ravenna) and established in the mid-1970s. Comecer develops and manufactures high-technology systems for aseptic treatment and containment in the pharmaceutical and nuclear medicine industries, specialising in isolation technology solutions for regenerative medicine and tissue engineering. Since 2019 Comecer is part of ATS Automation Tooling Systems Inc., a Canadian company listed on the Toronto Stock Exchange and a leading provider of industrial automation solutions for manufacturing companies in all production sectors.

Comecer Headquarters

Our mission is to design and manufacture high-technology systems in the field of pharma, radiopharma and regenerative medicine, with the aim to continuously increase the accuracy and the safety of technicians, researchers, and patients. In fact, “Safety First” is the philosophy that distinguishes and identifies all Comecer policies and actions. Our vision is to contribute to progress and preserve life through the development of highly innovative technologies and sustainable solutions, according to the latest GMP (Good Manufacturing Practice) regulations.

The company consists of three large business applications. Comecer operates in the Radiophamraceutical sector through the production of shielding systems and equipment for special applications, in the Pharmaceutical field with the production of isolators for aseptic filling and / or dispensing systems for the treatment of sterile and toxic substances, and in the regenerative medicine sector for the handling, expansion and production of Advanced Therapies Products (ATMP).

Comecer products are known and used in hospitals, universities, research centres, pharmaceutical companies and large industrial groups.

Comecer employs over 300 people under the leadership of President Simone Volpi and has an annual turnover of around 74 million euro (FY 2021). It realises about 55% of sales in the radiopharmaceutical equipment market, where the company’s specialised shielding systems are used for the production, management and distribution of radiopharmaceuticals for the diagnosis and therapeutic treatment of a number of diseases, including various forms of cancer and cardiovascular disorders. The balance of sales derives from equipment for aseptic processing and packaging of specialised pharmaceutical products, as well as the production of isolating equipment and incubators used in Advanced Therapy Medicinal Products (ATMP) and regenerative cell therapies that use patient cells to grow new tissue.

With three production sites in Castel Bolognese (Italy), DF Siena (Italy) and Joure (Netherlands), and offices in Chicago (USA), Dubai (UAE), Mumbai (India) and Taipei (Taiwan), Comecer markets its products in over 100 countries through a direct sales network and some technological partnerships for the joint development of new products.

The ability to build customised solutions for its customers is the basis of Comecer’s success. Operating in sectors where every customer has unique requirements means that applying standard solutions in most cases is not a good idea. This is why at Comecer new projects always start by listening to the customer’s needs and requirements. A dedicated project team analyses and understands the processes and the environment, since no two organisations have identical characteristics. This team collects all the data, considers every aspect and designs solutions. The possible alternatives that can meet the customer’s needs are then presented and discussed. Many customers are not aware of how much customisation is possible and are surprised when they see Comecer‘s proposals.

Comecer follows the product at every stage, from production to use in radiopharmaceutical laboratories and nuclear medicine facilities, certifies all its products, and all systems are tested and subjected to a wide range of validation tests according to the regulatory standards in force at the national, European and international level. In particular, Comecer adopts a code of ethics, called Safety first, which is more restrictive than the obligations and guidelines of current legislation, and pursues personal safety and environmental protection at the forefront of any company policy and action. Safety then translates into the quality of the materials and processes that make it possible to qualify Comecer’s products according to the highest industry standards.

Among the equipment produced by Comecer are cells for the manipulation of radioactive substances, automatic systems for distribution in vials or syringes and complete lines for the production and packaging of radiopharmaceuticals.

OUR STORY

Founded in the 1970s as a supplier for the Agenzia Nucleare Italiana (Italian Nuclear Agency), the Group forged a partnership with ENEA and Ansaldo carrying out many research projects. In 1985, with the block on nuclear energy development in Italy, Comecer transferred its technology and know-how to the field of medicine, forging important agreements with technological and research partners and asserting itself in 2000 as a manufacturer of shielded cells for the nuclear medicine industry. From 2005 the Company has witnessed an exponential growth in production due to international business.

Since March 2011, Fondo Italiano d’Investimento (Italian Investment Fund), a private equity vehicle founded upon an initiative of the Italian Ministry of Finance, has participated in the Comecer Group with a minority share.

In 2012 Comecer acquired two companies, Veenstra and Vitrae Czech, with the aim to increase its range of products and services in the field of electronic technologies and software programs both in Pharma and Radiopharma sectors.

Then, in November 2015, the fund Principia SGR replaced the Italian Investment Fund, with a stake of 45%: this operation contributed to support the growth and development of Comecer, with the medium-term aim of bringing the company on the Stock Exchange.

On March 1st, 2019, Comecer began a new journey as part of the multinational Canadian company ATS Automation Tooling Systems Inc. an industry-leading automation solutions provider.

Comecer Production

OUR ACTIVITY

The Group is currently divided into three business applications:

RADIOPHARMACEUTICAL

Comecer designs and builds systems and equipment for the safe treatment of radioactive substances used in Nuclear Medicine, guaranteeing minimum exposure to the operator, total decontamination and inalterability in any working condition. In particular, Comecer excels in the field of radiochemistry where, on behalf of large industrial groups or research institutes, it manufactures shielding systems for special applications. Radiopharmaceuticals are radioactive substances used to identify a specific part of the body through the emission of radio particles captured by gamma chambers and PET tomographs capable of offering accurate functional morphological images.

In the Nuclear Medicine sector, Comecer’s products are used in the most advanced and prestigious research centres, universities, hospitals and pharmaceutical companies worldwide.

PHARMACEUTICAL

Another important sector for Comecer is Isolation Technology, systems whose purpose is to reduce or completely eliminate the possibility of extreme contamination within a protected environment. Comecer specialises in the customised production of isolators, instruments that provide the highest level of separation and protection for the treatment of toxic and/or sterile substances to be used in pharmaceutical, chemical, cell culture, food and aerospace industries.

The portfolio covers various standard products, but also high-quality customised solutions thanks to specific expertise acquired over the years. Its containment solutions range from isolators that handle highly active principles or excipients to multi-stage isolators for chemical synthesis or laboratory operations. Its asepsis offerings include isolators designed for sterility tests and formulation of sterile drugs, and isolators or RABs integrated into filling lines. Comecer products are known and used in hospitals, universities, research centres, pharmaceutical companies and large industrial groups worldwide.

ATMP (Advanced Therapy Medicinal Products)

The third business area is dedicated to the equipment for the manipulation and treatment of biological medicinal products and in particular of Medicinal Products for Advanced Therapies (ATMP). Unlike drugs of chemical origin, these products require special processing equipment as well as specific environmental conditions to ensure compliance with sector-specific GMP (Good Manufacturing Practices), in addition to pharmaceutical regulations.

To this effect, Comecer has developed a system based on a technology which exploits ISOLATORS, where all equipment used conforms to the most stringent of standards and all regulations in force, is integrated into the main facility (therefore compliant with Class A certification of the environment in which it operates), can be centrally controlled by a single operator, is modular and flexible, generates space synergies and the ergonomic achievement of performance levels.

THE RESEARCH & DEVELOPMENT CENTRE

Thanks to its production flexibility, the continuous investments in research, the synergies between its various divisions and the sharing of know-how, Comecer always develops highly innovative products, from both the operator safety and product protection standpoints.

The Company’s technological drive is supported by a multi-functional and highly efficient Research & Development department, which is divided into several areas:

  • Mechanics – A team dedicated to the development of systems for the protection of both operators and medicinal products;
  • Automation – A team dedicated to the development of automated solutions for the fractionation and dispensing of radiopharmaceuticals;
  • Software – A team dedicated to the processes for the management of radiopharmaceuticals or medicinal products;
  • Materials – A team researching new materials for shielding and safety management;
  • Chemicals – A team working with universities to develop new radioisotopes.

SOME OF THE MOST INNOVATIVE PRODUCTS/SERVICES

THEODORICO – A robotic system that makes it possible to prepare the doses inside syringes and/or vials, reducing exposure to radiopharmaceuticals.

CLIO – A compact automatic dispenser for the fractionation of medicinal products inside vials and syringes, installable on hot cells;

ALCEOAn automatic system for the synthesis and dispensation of tracers coming from solid targets, unique in its kind;

IRIS – An automatic system that dispenses and injects the required dose of radiopharmaceutical directly to the patient.

WORKFLOW MANAGEMENT SOFTWARE FOR NUCLEAR MEDICINE – for use in nuclear medicine departments of hospitals and clinics, with client/server technology for laboratory management, quality control and validations.

HELIOSA fully automatic dispensing system for GMP aseptic processes using vials or syringes.

FLEXYCULTTM – A modular incubator for individual batches used for cell therapy, connected to a shared docking station, perfect for expanding cell factory production capacity.

MSTI (Modular Sterility Testing Isolator) – An isolator specifically designed for laboratories that require totally aseptic conditions to test the sterility of their pharmaceutical products.

BABY PHILL (Small Batch Vial Filling System) – A bottle filling line for clinical batches, development batches and the production of sterile, cytotoxic, liquid or freeze-dried drugs for the R&D, pharmaceutical and ATMP sectors.

These products, together with the others in the Comecer range, are validated and GMP and Medical Device certified where required.

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