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Quality Control In Tissue Engineering
The rapid development in the multidisciplinary field of tissue engineering has resulted in a variety of new and innovative medicinal products, often carrying living cells, intended to repair, regenerate or replace damaged human tissue. Tissue engineered medicinal products (TEMPs) vary in terms of the type and origin of cells and the product’s complexity. As all medicinal products, the safety and efficacy of TEMPs must be consistent throughout the manufacturing process. Quality control and assurance are of paramount importance and products are constantly assessed throughout the manufacturing process to ensure their safety, efficacy, consistency and reproducibility between batches. The European Medicines Agency (EMA) is responsible for the development, assessment and supervision of medicines in the EU. The appointed committees are involved in referral procedures concerning safety or the balance of benefit/risk of a medicinal product. In addition, the committees organize inspection ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Tissue Engineering
Tissue engineering is a biomedical engineering discipline that uses a combination of cells, engineering, materials methods, and suitable biochemical and physicochemical factors to restore, maintain, improve, or replace different types of biological tissues. Tissue engineering often involves the use of cells placed on tissue scaffolds in the formation of new viable tissue for a medical purpose but is not limited to applications involving cells and tissue scaffolds. While it was once categorized as a sub-field of biomaterials, having grown in scope and importance it can be considered as a field of its own. While most definitions of tissue engineering cover a broad range of applications, in practice the term is closely associated with applications that repair or replace portions of or whole tissues (i.e. bone, cartilage, blood vessels, bladder, skin, muscle etc.). Often, the tissues involved require certain mechanical and structural properties for proper functioning. The term has al ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cell Line
An immortalised cell line is a population of cells from a multicellular organism which would normally not proliferate indefinitely but, due to mutation, have evaded normal cellular senescence and instead can keep undergoing division. The cells can therefore be grown for prolonged periods ''in vitro''. The mutations required for immortality can occur naturally or be intentionally induced for experimental purposes. Immortal cell lines are a very important tool for research into the biochemistry and cell biology of multicellular organisms. Immortalised cell lines have also found uses in biotechnology. An immortalised cell line should not be confused with stem cells, which can also divide indefinitely, but form a normal part of the development of a multicellular organism. Relation to natural biology and pathology There are various immortal cell lines. Some of them are normal cell lines (e.g. derived from stem cells). Other immortalised cell lines are the ''in vitro'' equivalen ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Genetically Modified Organism
A genetically modified organism (GMO) is any organism whose genetic material has been altered using genetic engineering techniques. The exact definition of a genetically modified organism and what constitutes genetic engineering varies, with the most common being an organism altered in a way that "does not occur naturally by mating and/or natural recombination". A wide variety of organisms have been genetically modified (GM), from animals to plants and microorganisms. Genes have been transferred within the same species, across species (creating transgenic organisms), and even across kingdoms. New genes can be introduced, or endogenous genes can be enhanced, altered, or knocked out. Creating a genetically modified organism is a multi-step process. Genetic engineers must isolate the gene they wish to insert into the host organism and combine it with other genetic elements, including a promoter and terminator region and often a selectable marker. A number of techniques are ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality Control
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". This approach places emphasis on three aspects (enshrined in standards such as ISO 9001): # Elements such as controls, job management, defined and well managed processes, performance and integrity criteria, and identification of records # Competence, such as knowledge, skills, experience, and qualifications # Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team spirit, and quality relationships. Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analyzed). Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example. History and introduction ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality Considerations
Quality may refer to: Concepts * Quality (business), the ''non-inferiority'' or ''superiority'' of something * Quality (philosophy), an attribute or a property *Quality (physics), in response theory *Energy quality, used in various science disciplines *Logical quality, philosophical categorization of statements *Service quality, comparison of expectations with performance in a service * Vapor quality, in thermodynamics, the ratio of mass of vapor to that of vapor and liquid *Data quality, refers to the condition of a set of values of qualitative or quantitative variables Practices *Quality assurance (QA) *Quality control (QC) Places * Quality, Kentucky, an unincorporated community Brands and enterprises * Quality Comics, an American comic book publisher between 1939 and 1956 * Quality Communications, a comic book publisher started in 1982 * Quality Records, a Canadian entertainment company Music * ''Quality'' (CDQ album), 2016 * ''Quality'' (Talib Kweli album), 2002 *"Quality", ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cytokine
Cytokines are a broad and loose category of small proteins (~5–25 kDa) important in cell signaling. Cytokines are peptides and cannot cross the lipid bilayer of cells to enter the cytoplasm. Cytokines have been shown to be involved in autocrine, paracrine and endocrine signaling as immunomodulating agents. Cytokines include chemokines, interferons, interleukins, lymphokines, and tumour necrosis factors, but generally not hormones or growth factors (despite some overlap in the terminology). Cytokines are produced by a broad range of cells, including immune cells like macrophages, B lymphocytes, T lymphocytes and mast cells, as well as endothelial cells, fibroblasts, and various stromal cells; a given cytokine may be produced by more than one type of cell. They act through cell surface receptors and are especially important in the immune system; cytokines modulate the balance between humoral and cell-based immune responses, and they regulate the maturati ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Growth Factor
A growth factor is a naturally occurring substance capable of stimulating cell proliferation, wound healing, and occasionally cellular differentiation. Usually it is a secreted protein or a steroid hormone. Growth factors are important for regulating a variety of cellular processes. Growth factors typically act as signaling molecules between cells. Examples are cytokines and hormones that bind to specific receptors on the surface of their target cells. They often promote cell differentiation and maturation, which varies between growth factors. For example, epidermal growth factor (EGF) enhances osteogenic differentiation, while fibroblast growth factors and vascular endothelial growth factors stimulate blood vessel differentiation ( angiogenesis). Comparison to cytokines ''Growth factor'' is sometimes used interchangeably among scientists with the term ''cytokine.'' Historically, cytokines were associated with hematopoietic (blood and lymph forming) cells and imm ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Porosity
Porosity or void fraction is a measure of the void (i.e. "empty") spaces in a material, and is a fraction of the volume of voids over the total volume, between 0 and 1, or as a percentage between 0% and 100%. Strictly speaking, some tests measure the "accessible void", the total amount of void space accessible from the surface (cf. closed-cell foam). There are many ways to test porosity in a substance or part, such as industrial CT scanning. The term porosity is used in multiple fields including pharmaceutics, ceramics, metallurgy, materials, manufacturing, petrophysics, hydrology, earth sciences, soil mechanics, and engineering. Void fraction in two-phase flow In gas-liquid two-phase flow, the void fraction is defined as the fraction of the flow-channel volume that is occupied by the gas phase or, alternatively, as the fraction of the cross-sectional area of the channel that is occupied by the gas phase. Void fraction usually varies from location to location in the fl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cell Bank
A cell bank is a facility that stores cells of specific genome for the purpose of future use in a product or medicinal needs. They often contain expansive amounts of base cell material that can be utilized for various projects. Cell banks can be used to generate detailed characterizations of cell lines and can also help mitigate cross-contamination of a cell line. Utilizing cell banks also reduces the cost of cell culture processes, providing a cost-efficient alternative to keeping cells in culture constantly. Cell banks are commonly used within fields including stem cell research and pharmaceuticals, with cryopreservation being the traditional method of keeping cellular material intact. Cell banks also effectively reduce the frequency of a cell sample diversifying from natural cell divisions over time. Storage Before putting the donated cell lines into storage, they are first proliferated and multiplied into a large number of identical cells before being stored in a number of ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Immunogenicity
Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal. It may be wanted or unwanted: * Wanted immunogenicity typically relates to vaccines, where the injection of an antigen (the vaccine) provokes an immune response against the pathogen, protecting the organism from future exposure. Immunogenicity is a central aspect of vaccine development. * Unwanted immunogenicity is an immune response by an organism against a therapeutic antigen. This reaction leads to production of anti-drug-antibodies (ADAs), inactivating the therapeutic effects of the treatment and potentially inducing adverse effects. A challenge in biotherapy is predicting the immunogenic potential of novel protein therapeutics. For example, immunogenicity data from high-income countries are not always transferable to low-income and middle-income countries. Another challenge is considering how the immunogenicity of vaccines changes with ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medicinal Drug
A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management. Drugs are classified in multiple ways. One of the key divisions is by level of control, which distinguishes prescription drugs (those that a pharmacist dispenses only on the order of a physician, physician assistant, or qualified nurse) from over-the-counter drugs (those that consumers can order for themselves). Another key distinction is between traditional small molecule drugs, usually derived from chemical synthesis, and biopharmaceuticals, which include recombinant proteins, vaccines, blood products used therapeutically (such as IVIG), gene therapy, monoclonal antibodies and cell therapy (for instance, stem cell therapies). Other ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Risk Assessment
Broadly speaking, a risk assessment is the combined effort of: # identifying and analyzing potential (future) events that may negatively impact individuals, assets, and/or the environment (i.e. hazard analysis); and # making judgments "on the tolerability of the risk on the basis of a risk analysis" while considering influencing factors (i.e. risk evaluation). Put in simpler terms, a risk assessment determines possible mishaps, their likelihood and consequences, and the tolerances for such events. The results of this process may be expressed in a quantitative or qualitative fashion. Risk assessment is an inherent part of a broader risk management strategy to help reduce any potential risk-related consequences. Need Individual risk assessment Risk assessment are done in individual cases, including patient and physician interactions. Individual judgements or assessments of risk may be affected by psychological, ideological, religious or otherwise subjective factors, which imp ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
