Product and Process Development
Sanquin has several departments focusing on innovation and improving products, processes, and services for their primary activities. These activities are done in collaboration with the division Plasma Products.
Product Development Plasma Products
The product development strategy of the division Plasma Products primarily aims at maintaining the state-of-the-art level of its plasma derivatives portfolio and production processes. To that end, the product and process development program is regularly evaluated and updated if needed. Besides, opportunities for development of new (plasma) products are being explored in feasibility studies which may evolve into full-blown development projects when considered to be economically feasible.
Product Development CAF-DCF
The CAF-DCF Product Development Division (former R&D) is located in Brussels. For its staff, research and development means ensuring both the efficacy of plasma-derived medicinal products and their biological safety regarding pathogens, pollutants, and accompanying proteins. Focusing on therapeutic proteins (IVIG, albumin, AGP, FVIII) and their excipients in plasma and concentrates, the division develops both immunological methods and biochemical-biophysical techniques and exploits them in industrial applications. The paradigm of plasma derivative safety is approached through projects in different areas: NAT screening, collection and statistical evaluation of critical virus epidemiological data, neutralization by specific antibodies, virus infectivity testing in a cell model, virus inactivation/virus elimination validation studies, and pathogen reduction techniques (including UVC irradiation developed in our R&D Division).
Medical Department Plasma Products
The Medical Department is, in its applied research activities, responsible for the design and conduct of clinical trials with (recently developed) plasma products. The Medical Department closely cooperates with clinical investigators in the Netherlands e.g. the Netherlands Inter-University Working Party on the Study of Immune Deficiencies and the Dutch Haemophilia Treatment Centres, and with investigators abroad. In 2010, three clinical studies with intravenous immunoglobulin, Nanogam®, were ongoing in order to study the efficacy and safety of Nanogam® in different clinical conditions. Moreover, a clinical study with apotransferrin was initiated, and preparations were made for a clinical study with a newly developed FVIII product.
Product and Process Development (PPO) of the division Blood Bank
The Department of Product and Process Development of the division Blood Bank is involved in many fields of blood banking. The department is part of the unit Production, but studies are performed for the other Blood Bank units as well.
To warrant optimal interaction between the Blood Bank operational needs and knowledge available within the division Research, the staff of PPO has also positions in the division Research (department Blood Cell Research and Clinical Transfusion Research) or in the unit Transfusion Medicine.
Most studies are for operational support, to obtain detailed knowledge about the manufacturing process or to solve occurring problems. Other studies are performed to obtain background knowledge for QA to allow evidence-based decisions in case of deviations, for example in temperature conditions. An important role of the department is to explore possibilities for new products, either to be produced by the Blood Bank from donor blood, or new applications for already-existing products. Some of these projects are performed with an external partner, both as contract research or as joint development.
Product Development Sanquin Reagents
Sanquin Reagents developed a broad range of blood grouping and immunology reagents for laboratories, including several innovative products for diagnostic use and for clinical research. These reagents are worldwide available through a network of distributors, and bulk reagents for manufacturing are supplied directly from Amsterdam. The Reagents Unit is ISO 9001 and ISO 13485 certified and is committed to introduce new products on a continuous basis. New products are the outcome of R&D projects, some of which are executed in close collaboration with departments within Sanquin and/or with other companies and institutions.
Pharmaceutical Services is a business unit specialized in a broad array of pharmaceutical services aiming at the development and quality testing of biologicals intended for therapeutic application in humans. These services include the development of adequate production processes, contract production of mammalian cell products (monoclonal antibodies and/or r-DNA) as well as safety testing and designing validation studies for assays and processes, including viral reduction studies.
Diagnostic Services excels in routine and top-reference specialized testing in the field of blood-related diseases and immune-mediated disorders. The blood sample testing is carried out in Amsterdam and is available to all Health Care Institutions and commercial companies in the Netherlands and abroad. The division aims to work according to the highest quality standards in order to function as a diagnostic reference center in the fields mentioned above, in national as well as in international settings. With its fully certified laboratories, Sanquin Diagnostic Services can provide a vast array of both routine and tailor-made diagnostic tests. Sanquin Diagnostic Services is committed to continuous innovation reflected by introduction of new diagnostic tests. New tests are often developed and validated in house, in R&D projects, most of which are carried out in close cooperation with Sanquin Research.
The mission of Sanquin Consultancy Services (SCS) is to provide guidance and advice services to restricted economy countries. Objectives are:
1. Support restricted economy countries in developing safe, efficacious and sustainable blood supply systems based on current quality principles.
2. Provide modular training programs on transfusion medicine for restricted economy countries focused on the managerial and quality aspects of the transfusion chain.
3. Extend and strengthen the training and consultative potential within the Sanquin organization.