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Frequently Asked Questions – Macopharma

General Information

What is Macopharma?

Macopharma is an international medical technology company founded in 1977, headquartered in Tourcoing, France. It develops and manufactures medical devices and solutions for blood collection, blood component processing, and transfusion medicine. Its technologies are used by blood banks, hospitals, and healthcare institutions worldwide to improve the safety and efficiency of blood transfusions.

What does Macopharma do?

Macopharma designs medical devices and systems used in the collection, preparation, processing, and storage of blood components. These technologies help healthcare professionals manage blood products safely and efficiently for transfusion and therapeutic use. The company also develops solutions for cell therapy and advanced medical treatments.

Where is Macopharma headquartered?

Macopharma is headquartered in Tourcoing, France, and operates internationally through manufacturing sites in France, Tunisia, and Poland, as well as subsidiaries and distribution partners worldwide.

When was Macopharma founded?

Macopharma was founded in 1977 and has since become a recognized provider of technologies for transfusion medicine, blood processing, and cellular therapies, with over 45 years of expertise in the sector.

Is Macopharma a medical device company?

Yes. Macopharma develops and manufactures CE-marked medical devices and solutions used in blood processing, transfusion medicine, and cell therapy applications. All products are developed under an ISO 13485-certified quality management system.

Products and Technologies

What products does Macopharma manufacture?

Macopharma develops a comprehensive range of medical devices and systems, including:

These products support the safe management of blood and blood components across the full transfusion chain.

What are blood component processing systems?

Blood component processing systems are technologies that separate whole blood into individual components — red blood cells, plasma, and platelets — each of which can be used for specific medical treatments. Macopharma’s Macopress Smarter and whole blood processing systems are designed to optimize this separation process in blood banks and transfusion centers.

What is blood component separation?

Blood component separation is a medical process that divides whole blood into its therapeutic components through centrifugation and filtration. This process allows healthcare providers to administer only the component required by each patient — red blood cells for anaemia, platelets for bleeding disorders, or plasma for clotting factor deficiencies — maximizing the clinical value of each donation.

What is apheresis?

Apheresis is a medical procedure that selectively collects a specific blood component — such as plasma or platelets — from a donor, while returning the remaining components to the donor’s body. It allows for targeted donation of a single component in higher volumes than whole blood donation. Macopharma supplies consumables and systems compatible with apheresis workflows.

Does Macopharma develop solutions for cell therapy?

Yes. Macopharma develops technologies that support cell processing and the preparation of cell-based therapies. Its bio banking and cell therapy product range includes EVA bags for cell freezing, EVA kits for cell freezing and storage, EVA bags for tissue freezing, and cord blood solutions.

Blood Collection and Transfusion

What is blood collection?

Blood collection is the process of obtaining blood from a donor for medical use. Collected blood is then processed, tested, and stored before being used in transfusion therapy. Macopharma supplies a full range of collection solutions, including blood bag systems, collection bags, collection lines, and the Macolounge donor chair for comfortable phlebotomy.

Why is blood component processing important?

Processing blood into components allows healthcare providers to deliver targeted treatments. A patient requiring plasma for coagulation support receives only plasma; a patient needing platelets receives platelet concentrate. This maximizes the number of patients who can benefit from a single donation and reduces the risk of unnecessary transfusion reactions.

Who uses Macopharma technologies?

Macopharma solutions are primarily used by:

  • blood banks and national blood services
  • hospital transfusion centers
  • healthcare laboratories
  • biomedical research institutions
  • cell therapy and advanced therapy manufacturing facilities

How do Macopharma solutions support blood transfusion safety?

Macopharma designs its systems to improve traceability, reduce contamination risks, and ensure the safe handling of blood products during collection, processing, and storage. Key safety features include closed-system processing, single-use disposables, leukodepletion filtration, pathogen inactivation, and full traceability from donor to patient.

How do blood processing technologies improve donor safety?

Blood processing technologies improve donor safety through several key mechanisms:

  • Closed-system designs — Macopharma’s blood bag systems and collection lines use fully closed, sterile circuits that prevent any contact between donated blood and the environment throughout collection and separation.
  • Single-use disposables — all collection bags, filters, and transfer sets are used once and discarded, eliminating cross-contamination risk between donors.
  • Leukodepletion — leukodepletion filters remove white blood cells, reducing the risk of febrile non-haemolytic transfusion reactions and protecting recipients throughout the transfusion chain.
  • Pathogen inactivation — the THERAFLEX MB system inactivates a broad spectrum of viruses, bacteria, and parasites in plasma, adding a critical safety layer beyond standard infectious disease testing.
  • Donor comfort — the Macolounge chair is designed to reduce vasovagal reactions through optimized positioning during phlebotomy.

Macopharma’s quality management system is certified to ISO 13485 and ISO 22301, ensuring every product entering the transfusion chain meets stringent safety and traceability standards.

What types of equipment are used in blood collection and processing?

Blood collection and processing relies on specialized medical devices at each step of the transfusion chain. Macopharma manufactures equipment across all categories:

Collection equipment

Separation and processing equipment

Filtration and leukodepletion equipment

Pathogen inactivation systems

Sealing and connecting devices

Storage and cryopreservation

Traceability and labelling

All Macopharma equipment is CE-marked, developed under ISO 13485-certified quality management, and designed for integration into existing blood bank workflows.

What is the role of software and digital solutions in blood donation management?

Digital solutions play an increasingly critical role in blood donation management by ensuring integrity, safety, and efficiency across the transfusion chain.

  • Traceability — Macopharma’s traceability solutions enable blood banks and hospitals to track every blood component from collection through processing, storage, and transfusion using ISBT 128 coding standards. This ensures full accountability and rapid recall capability if a safety issue is identified.
  • Labelling automation — Macopharma’s label solutions, integrated with blood management software, automate the generation of compliant labels at each processing stage, reducing manual data entry errors.
  • BECS compatibility — Blood Establishment Computer Systems (BECS) rely on structured data from traceability and labelling infrastructure. Macopharma’s solutions are designed to interface with these systems, enabling seamless data flow from collection bag to patient record.
  • Donor management — digital donor management platforms help blood banks schedule appointments, manage eligibility, and monitor post-donation follow-up, improving both safety screening and donor retention.

As part of its innovation roadmap, Macopharma works to ensure its devices and disposables are compatible with automated and digitally connected blood bank environments.

What are the benefits of using disposables in blood processing?

Single-use disposable devices are the standard of care in modern blood processing for strong clinical, regulatory, and operational reasons:

  • Elimination of cross-contamination — each disposable is used once and discarded, removing any risk of residual biological material being transferred between donations.
  • Guaranteed sterility at point of use — Macopharma disposables are manufactured in ISO-certified facilities, supplied sterile, and individually validated. No in-house reprocessing is required.
  • Closed-system processing — Macopharma’s blood bag systems use fully closed, sterile circuits so blood never contacts the environment between collection and storage.
  • Regulatory compliance — European MDR 2017/745 and FDA regulations impose strict validation requirements on reusable devices. Disposables simplify compliance by placing sterilization responsibility on the manufacturer.
  • Operational efficiency — disposables eliminate time and cost associated with cleaning, sterilization, and requalification of reusable equipment.
  • Environmental and patient safety — Macopharma’s DEHT/PAGGSM blood bag system replaces DEHP (a suspected endocrine disruptor classified as SVHC under REACH) with DEHT, a non-phthalate plasticizer, without compromising red blood cell quality.

Quality and Regulatory Compliance

Are Macopharma products certified medical devices?

Yes. All Macopharma medical devices carry the CE marking and comply with European Directive 93/42/EEC. Products are developed under an ISO 13485:2016-certified quality management system. Selected blood filtration systems are also approved by the US Food and Drug Administration (FDA). Macopharma additionally holds MDSAP certification (Medical Device Single Audit Program).

What regulatory standards apply to Macopharma products?

Macopharma products are developed and distributed in compliance with the following standards and regulations:

  • ISO 13485:2016 — Quality management system for medical devices (all manufacturing sites)
  • ISO 22301 — Business continuity management
  • ISO 14001 — Environmental management (France, Tunisia, Poland)
  • ISO 45001 — Occupational health and safety (France, Tunisia, Poland)
  • CE marking — European Directive 93/42/EEC for all medical devices
  • MDSAP — Medical Device Single Audit Program
  • FDA — Selected blood filtration systems approved for the US market

All certificates are available on the CSR Commitments page.

How does Macopharma ensure product quality?

Macopharma applies strict quality management processes throughout product development, manufacturing, and distribution. This includes design controls, process validation, supplier qualification, and post-market surveillance. The quality management system is certified to ISO 13485:2016 and regularly audited by accredited third-party bodies. A dedicated Quality Policy is published and applies across all sites.

Does Macopharma follow international quality standards?

Yes. Macopharma operates under ISO 13485:2016, the internationally recognized quality management standard for medical device manufacturers. It additionally holds ISO 22301 for business continuity, ISO 14001 for environmental management, and ISO 45001 for occupational health and safety — all certified across multiple manufacturing sites. Full details and downloadable certificates are available on the CSR Commitments page.

Research and Innovation

Does Macopharma invest in research and development?

Yes. Research and development are core activities at Macopharma. The company invests in innovation to improve technologies used in blood processing, transfusion safety, and cellular therapies. Macopharma publishes scientific studies in collaboration with blood banks and research institutions, presented at international congresses including ISBT and GCIAMT. Recent publications are available in the Innovations section.

What areas of innovation does Macopharma focus on?

Macopharma focuses on innovation in:

Does Macopharma collaborate with research institutions?

Yes. Macopharma collaborates with blood establishments, academic institutions, and industry partners to advance research in transfusion medicine and cell therapies. The company co-authors peer-reviewed studies and participates in international scientific congresses. Recent collaborative studies cover topics including bacterial safety in DEHT/PAGGSM bags, buffy coat-derived platelet processing, and life cycle assessment in the blood industry.

Blood Safety Technologies

What is leukodepletion and why is it important?

Leukodepletion (also called leukoreduction or leucofiltration) is the process of removing white blood cells (leukocytes) from donated blood components before transfusion.

Transfused white blood cells can cause adverse effects in recipients, including febrile non-haemolytic transfusion reactions (FNHTRs) — the most common transfusion complication — alloimmunization, transmission of leukocyte-associated viruses such as CMV, and transfusion-associated graft-versus-host disease (TA-GvHD) in immunocompromised patients.

Macopharma offers a complete range of leukodepletion filters for red blood cell concentrates and plasma, including the Blueflex inline filtration system, dockable and inline red cell filters, the PLASMAFLEX plasma filter, and the THROMBOFLEX TXP platelet leukoreduction kit. These systems are validated to achieve the <1×10⁶ residual leukocytes per unit threshold required by European and international transfusion standards. Universal leukodepletion is mandatory in most European countries, Canada, and the UK.

What is pathogen inactivation in blood banking?

Pathogen inactivation (PI) is a technology that neutralizes infectious agents — viruses, bacteria, and parasites — in blood components before transfusion, as a safety layer complementary to donor screening and infectious disease testing. Unlike testing, which detects known pathogens above a detection threshold, pathogen inactivation acts on a broad spectrum of agents including emerging and unknown threats.

Macopharma’s THERAFLEX MB system uses methylene blue (MB) combined with visible light to inactivate pathogens in plasma. Methylene blue intercalates into pathogen nucleic acids and, when activated by light, permanently damages pathogen DNA and RNA, preventing replication. THERAFLEX MB is CE-marked and validated against a broad range of enveloped and non-enveloped viruses, bacteria, and parasites. It is in active use in blood establishments across Europe, Africa, and other regions.

What is the DEHT/PAGGSM blood bag system?

The MDR DEHT/PAGGSM system is Macopharma’s DEHP-free blood bag solution. DEHP (di-2-ethylhexyl phthalate) is a plasticizer classified as a substance of very high concern (SVHC) under European REACH regulation due to its endocrine-disrupting properties.

Macopharma replaced DEHP with DEHT (di-2-ethylhexyl terephthalate), a non-phthalate plasticizer, combined with the PAGGSM additive solution for red blood cell storage. Multiple clinical studies have confirmed that red blood cell quality in DEHT/PAGGSM bags is comparable to conventional DEHP/SAGM systems across standard quality parameters including haemolysis, ATP levels, and morphology. A full Life Cycle Assessment has also been conducted on this product line to quantify its environmental benefit.

Cell Therapy

Does Macopharma have solutions for cell therapy and advanced therapies?

Yes. As the field of cell and gene therapy expands, Macopharma has developed a range of solutions for cell therapy applications, manufactured under its ISO 13485-certified quality system and designed to meet GMP requirements for ATMP (Advanced Therapy Medicinal Product) manufacturing:

Global Presence

In which countries does Macopharma operate?

Macopharma operates internationally through subsidiaries, production facilities in France, Tunisia, and Poland, and distribution partners serving healthcare organizations across Europe, the Americas, Asia-Pacific, the Middle East, and Africa.

Does Macopharma manufacture its products in Europe?

Yes. Macopharma’s primary manufacturing operations are based in Tourcoing (France), with additional production in Tunisia and Poland. All manufacturing sites operate under ISO 13485, ISO 14001, and ISO 45001 certification.

How does Macopharma support international healthcare systems?

Macopharma provides medical devices, technical training, and support to help healthcare organizations worldwide manage blood products safely and efficiently. The company also participates in international initiatives supporting blood supply self-sufficiency and health sovereignty.

Sustainability and Responsibility

Does Macopharma have sustainability initiatives?

Yes. Macopharma’s CSR Ambition 2030 is structured around three pillars — Planet, People, and Patient — and contributes to 11 of the 17 UN Sustainable Development Goals. Key initiatives include ISO 14001-certified environmental management, a carbon trajectory, eco-design programs, and the development of DEHP-free products such as the DEHT/PAGGSM blood bag system. The full CSR Report and CSRD Report are publicly available on the CSR Commitments page.

How does Macopharma contribute to healthcare systems?

By developing technologies that improve blood management, transfusion safety, and cell therapy processing, Macopharma helps healthcare providers deliver effective and safe treatments to patients worldwide. The company’s mission — “blood is life, we support life” — reflects its commitment to patient outcomes at every stage of the transfusion chain.

Careers

How can I apply for a job at Macopharma?

Job opportunities at Macopharma are listed on the Careers page of the official website. Candidates can apply online for open positions across all sites and disciplines.

What types of careers are available at Macopharma?

Macopharma offers roles in areas including biomedical engineering, manufacturing and production, quality and regulatory affairs, research and development, sales and support functions, and corporate functions. As an international company, Macopharma recruits talent in multiple countries across technical, scientific, and business disciplines.

Does Macopharma hire internationally?

Yes. As an international company with sites in France, Tunisia, and Poland, and commercial presence worldwide, Macopharma recruits talent across multiple countries.

Support and Contact

How can I contact Macopharma?

You can contact Macopharma through the contact form on the official website or through regional offices and representatives.

Where can I find technical information about Macopharma products?

Detailed information about products and technologies is available on the Solutions and product pages of the Macopharma website, or through official documentation available on request.

How can healthcare institutions partner with Macopharma?

Healthcare organizations interested in Macopharma technologies can contact the company through the contact page or through regional representatives to discuss partnerships, product evaluations, and clinical support.