Advanced therapy specialist jargon
Transforming a digital sketch to a three-dimensional object by means of depositing many layers of one or more materials (plastics, ceramics, metals, biologics, cells, etc.) on top of each other.
Training machines/computers how they should behave when encountering a specific problem or task. The computer remembers “past experiences” and uses a set of complex algorithms and statistics to predict what is the best course-of-action when facing new problems or tasks without the computer initially being programmed to execute these specific tasks.
ATMP (Advanced Therapy Medicinal Product)
According to Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products, ATMP means “any of the following medicinal products for human use: a gene therapy medicinal product as defined in Part IV of Annex I to Directive 2001/83/EC; a somatic cell therapy medicinal product as defined in Part IV of Annex I to Directive 2001/83/EC; a tissue engineered product”.
Tissue engineered product
As defined by EC Regulation No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products, “a ‘tissue engineered product’ means a product that: contains or consists of engineered cells or tissues, and that is presented as having properties for, or is used in or administered to human beings with a view to regenerating, repairing or replacing a human tissue. A tissue engineered product may contain cells or tissues of human or animal origin, or both. The cells or tissues may be viable or non-viable. It may also contain additional substances, such as cellular products, bio-molecules, biomaterials, chemical substances, scaffolds or matrices. Products containing or consisting exclusively of non-viable human or animal cells and/or tissues, which do not contain any viable cells or tissues and which do not act principally by pharmacological, immunological or metabolic action, shall be excluded from this definition”.
Gene therapy medicinal product
As defined by directive 2001/83/EC of the European Parliament and of the Council on the community code relating to medicinal products for human use, “a gene therapy medicinal product means a biological medicinal product which has the following characteristics: it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence; its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence. Gene therapy medicinal products shall not include vaccines against infectious diseases”.
Somatic cell therapy medicinal product
As defined by directive 2001/83/EC of the European Parliament and of the Council on the community code relating to medicinal products for human use, “a somatic cell therapy medicinal product means a biological medicinal product which has the following characteristics: it contains or consists of cells or tissues that have been subject to substantial manipulation so that biological characteristics, physiological functions or structural properties relevant for the intended clinical use have been altered, or of cells or tissues that are not intended to be used for the same essential function(s) in the recipient and the donor; it is presented as having properties for, or is used in or administered to human beings with a view to treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues”.
Any material that has been modified or engineered for medical purposes and that is in contact with a biological system. This can be either for therapeutic or diagnostic reasons. Well-known applications of biomaterials are for example hip implants, suture materials and vascular stents. Make sure not to confuse biomaterials with biological materials, as the latter are produced by biological systems (e.g. bone, pollen, cells, skin, leafs, etc.).
A bioprocess aims at converting raw materials into valuable end products by harnessing the power of living cells and/or their derivatives (e.g. enzymes). The first example that comes to mind is one of the most ancient forms of biotechnology, namely the production of beer. In bioprocessing, it is of the utmost importance that the technologies are scalable and robust to control quality and economics.
A bioreactor can be any (closed) system that has been designed to mimic and support a biological system or process, including monitoring & control technology. Bioreactors can be used to transition from an open and manual manufacturing process towards a closed and automated manufacturing process.
The industry 4.0 refers to the idea where factories in the future would be (almost) fully automated through the use of technologies such as artificial intelligence, machine learning, cloud computing, and the Internet of Things.
Any device intended for internal or external medical use. These devices can support physicians to monitor of help patients and are categorized according to their risk for the patients’ health. A low-risk medical device can be as simple as a thermometer, while high-risk medical devices are mostly implants. As the level of risk associated with the device increases, the amount of testing required to receive permission to bring the device to the market increases as well.
This is hailed as the future of medicine. It is the exact opposite of the one-medicine-fits-all approach and uses the vast amount of data of the individual to develop a customized treatment that targets improved patient outcome and sustainable healthcare.
Quality by Design
The Quality by Design (QbD) methodology aims at increasing product and process quality by means of setting clear targets, mapping the process, defining all the influential parameters, performing risk assessments, finding ways to lower the risks through experimentation and iteration, and finally make well-founded decisions based on the obtained data. This is an established principle in the automotive industry, but it has also been approved by the Food and Drug Administration (FDA) for drug manufacturing.
Regenerative medicine is an overarching term for many technologies and scientific disciplines and aims at regenerating cells, tissues or organs to replace or restore damaged cells, tissues or organs. The field of tissue engineering is categorized under regenerative medicine.
A scaffold is commonly used in tissue engineering as a (spatial and temporary) support structure on which cells can attach, grow and regenerate.
A cell that can perform self-renewal (produce more of the same type of cells), but that also holds the potential to differentiate into many other types of specialized cells.
A network of multiple parties (organizations, universities, companies,…) that works together towards a common goal through the execution of multi-stakeholder projects.