CELLULAR THERAPY DEPARTMENT

In 1989, we started our activity collaborating in the collection and preparation of bone marrow from related donors for allogeneic transplantation. In 1992, we performed the first cryopreservation of an autologous bone marrow. Two years later, we began to collect hematopoietic progenitor cells by apheresis. In 1996, we conducted the first cell importation from an unrelated donor and since 2000 we have been collecting and exporting cells from donors of the Portuguese National Registry to several international transplant centers. In 2006, the Apheresis Unit and the Processing Facility were united and the Cellular Therapy Department was created. The number of cell collections and technical procedures incremented significantly, which made it possible to respond to the increase of transplantation activity in the new inpatient unit. In 2008, we implemented an extracorporeal photopheresis protocol and 7 years later an alternative “off-line” method. In 2013, our quality management system became autonomous, potentianting the Department’s national and international recognition. In recent years, the research activity has been developed, including the collaboration in clinical trials and implementation of emerging cell immunotherapies, namely the CAR T cell therapy program.

Since Department’s beginning, we have sought to establish values and objectives, respect the Institution’s mission and align with its three strategic axes:

1. PATIENT-CENTERED CARE

Clinical and analytical assessment of patients and donors for:

– Cell and bone marrow collection from adult and pediatric patients for autologous hematopoietic transplantation

– Cell and bone marrow collection from adult and pediatric donors, related and unrelated, for allogeneic hematopoietic transplantation of patients at national or international centers

– Collection of T cells from adult and pediatric donors, related or unrelated, for the prevention and treatment of post-transplant relapse of patients at national or international centers

– Collection of mononuclear cells from adult patients for CAR T cell therapy

– Extracorporeal photopheresis (classic and off-line method) in adult and pediatric patients for the treatment of Graft Versus Host Disease or Cutaneous T-cell Lymphoma

Peripheral blood haematopoietic progenitor cells and mononuclear cells are harvested by apheresis and bone marrow by bone puncture.

All celular therapy products undergo rigorous quality control, and go to processing, cryopreservation, thawing and/or distribution according to the therapeutic indication. In well-defined situations, we perform in vitro immunomagnetic selection of specific cell populations; and processing of unrelated umbilical cord blood.

2. INNOVATION IN ONCOLOGY

In order to keep up with the cutting-edge technologies, we conduct research studies and collaborate in clinical trials with internal and external clinics and facilities.

With the aim of developing Advanced Therapy Medicines, we are implementing current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) complying with ALCOA and ALCOA+ principles in manual records and computerized systems.

We have an active training and teaching program for different professionals and we provide internships and various scientific actions.

We also perform several studies to assess the clinical efficacy of our cellular therapy products and the outcome of cell and bone marrow donors.

3. DIMENSION AND QUALITY

We believe that an effective resource management, a good activity planning and a dynamic coordination within our professional team have a real impact on the value of products and services we offer to our patients and donors.

3.1. Facility

Our Department is located at the building E and is divided into two main areas: clinic, on the third floor, and laboratorial, on the first and third floors.

We have an attending area to evaluate patients and donors, an apheresis room for adults and a special one for pediatrics; we also have the support of an inpatient unit and an operatory room for bone marrow collections.

We own two classified and controlled rooms for cell processing, a controlled room with nitrogen tanks for cell cryopreservation, and flow cytometry and cell biology laboratories for quality control.

3.2. Professional team

Our Department has a multidisciplinary team with medical doctors specialized in Immunohemotherapy, a resident team, technicians, nurses, technical and operational assistants.

3.3. Management, quality and safety systems

– Authorization by the Direção Geral de Saúde (DGS) to carry out the following activities: collection from adult/pediatric patients and donors, analysis, processing, cryopreservation and distribution of hematopoietic progenitor cells from peripheral blood, bone marrow or umbilical cord blood, and mononuclear cells

– Authorization by the Instituto Português do Sangue e da Transplantação (IPST), IP for the importation of cells of human origin

– ISO 9001 certification by the Associação Portuguesa de Certificação (APCER) for the validation of our quality management system, risk mitigation and continuous improvement

– Accreditation by the Joint Accreditation Committee ISCT & EBMT (JACIE) integrating the international network of centers of excellence in the field of cellular immunotherapies

– Reference center by the Portuguese National Registry, CEDACE for the collection and exportation of cells and bone marrow

– Authorization by the Food and Drug Administration (FDA) for the distribution of cells to the United States of America according to their requirements

– Registration with the International Council for Commonality in Blood Banking Automation (ICCBBA) to use the ISBT 128 standard on identification labels, ensuring traceability from donor to patient and reciprocally

– Registration as European Union Tissue Establishment to work according to european directives

 – Qualification as a Cellular Therapy Center by pharmaceutical companies for the collection, cryopreservation and shipment of cells for the production of CAR T cells and further reception and preparation of the final product for patient infusion

– Member of the World Marrow Donor Association (WMDA) to ensure the protection of the rights and safety of donors and promote the quality of exported cellular products through standardization and global collaboration