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Bioprocess
A bioprocess is a specific process that uses complete living cells or their components (e.g., bacteria, enzymes, chloroplasts) to obtain desired products. Transport of energy and mass is fundamental to many biological and environmental processes. Areas, from food processing (including brewing beer) to thermal design of buildings to biomedical devices, manufacture of monoclonal antibodies to pollution control and global warming, require knowledge of how energy and mass can be transported through materials (momentum, heat transfer, etc.). Cell bioprocessing Cell therapy bioprocessing is a discipline that bridges the fields of cell therapy and bioprocessing (i.e., biopharmaceutical manufacturing), and is a sub-field of bioprocess engineering. The goals of cell therapy bioprocessing are to establish reproducible and robust manufacturing processes for the production of therapeutic cells.Rowley, J.A. Developing Cell Therapy Biomanufacturing Processes, Chem Eng Progress, SBE Stem ...
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Bioprocess Engineering
Bioprocess engineering, also biochemical engineering, is a specialization of chemical engineering or biological engineering. It deals with the design and development of equipment and processes for the manufacturing of products such as agriculture, food, feed, pharmaceuticals, nutraceuticals, chemicals, and polymers and paper from biological materials & treatment of waste water. Bioprocess engineering is a conglomerate of mathematics, biology and industrial design, and consists of various spectrums like the design and study of bioreactors (operational mode, instrumentation, and physical layout) to the creation of kinetic models. It also deals with studying various biotechnological processes used in industries for large scale production of biological product for optimization of yield in the end product and the quality of end product. Bioprocess engineering may include the work of mechanical, electrical, and industrial engineers to apply principles of their disciplines to processes ...
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Keck Graduate Institute Of Applied Life Sciences
Keck Graduate Institute (KGI) is a private graduate school in Claremont, California. Founded by Henry Riggs in 1997, it is the seventh and newest member of the Claremont Colleges. History Henry Riggs, then president of Harvey Mudd College, established the institute in 1997 to address what he perceived as a lack of scientists trained to convert new scientific discoveries into practical uses. He also became the institute's first president, serving until 2003. The decision to establish Keck Graduate Institute as a seventh Claremont College was met with some opposition, particularly from faculty of the other Claremont Colleges who objected to its lack of tenure, and environmentalists who opposed its plans to build a campus next to the Bernard Field Station, an area of undeveloped scrubland. The environmental issue was largely settled when KGI decided to establish its campus at a different location, and other opposition gradually faded. The institute received a $50 million endo ...
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Food Processing
Food processing is the transformation of agricultural products into food, or of one form of food into other forms. Food processing includes many forms of processing foods, from grinding grain to make raw flour to home cooking to complex industrial methods used to make convenience foods. Some food processing methods play important roles in reducing food waste and improving food preservation, thus reducing the total environmental impact of agriculture and improving food security. Primary food processing is necessary to make most foods edible, and secondary food processing turns the ingredients into familiar foods, such as bread. Tertiary food processing has been criticized for promoting overnutrition and obesity, containing too much sugar and salt, too little fiber, and otherwise being unhealthful in respect to dietary needs of humans and farm animals. Process Primary food processing Primary food processing turns agricultural products, such as raw wheat kernels o ...
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Brewing
Brewing is the production of beer by steeping a starch source (commonly cereal grains, the most popular of which is barley) in water and fermenting the resulting sweet liquid with yeast. It may be done in a brewery by a commercial brewer, at home by a homebrewer, or communally. Brewing has taken place since around the 6th millennium BC, and archaeological evidence suggests that emerging civilizations, including ancient Egypt and Mesopotamia, brewed beer. Since the nineteenth century the brewing industry has been part of most western economies. The basic ingredients of beer are water and a fermentable starch source such as malted barley. Most beer is fermented with a brewer's yeast and flavoured with hops. Less widely used starch sources include millet, sorghum and cassava. Secondary sources (adjuncts), such as maize (corn), rice, or sugar, may also be used, sometimes to reduce cost, or to add a feature, such as adding wheat to aid in retaining the foamy head of the beer. ...
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Cell Therapy
Cell therapy (also called cellular therapy, cell transplantation, or cytotherapy) is a therapy in which viable cells are injected, grafted or implanted into a patient in order to effectuate a medicinal effect, for example, by transplanting T-cells capable of fighting cancer cells via cell-mediated immunity in the course of immunotherapy, or grafting stem cells to regenerate diseased tissues. Cell therapy originated in the nineteenth century when scientists experimented by injecting animal material in an attempt to prevent and treat illness. Although such attempts produced no positive benefit, further research found in the mid twentieth century that human cells could be used to help prevent the human body rejecting transplanted organs, leading in time to successful bone marrow transplantation as has become common practice in treatment for patients that have compromised bone marrow after disease, infection, radiation or chemotherapy. In recent decades, however, stem cell and cel ...
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Adverse Drug Reaction
An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs. The meaning of this term differs from the term "side effect" because side effects can be beneficial as well as detrimental. The study of ADRs is the concern of the field known as ''pharmacovigilance''. An adverse drug event (ADE) refers to any unexpected and inappropriate occurrence at the time a drug is used, whether or not associated with the administration of the drug. An ADR is a special type of ADE in which a causative relationship can be shown. ADRs are only one type of medication-related harm, as harm can also be caused by omitting to take indicated medications. Classification ADRs may be classified by e.g. cause and severity. Cause *Type A: Augmented pharmacologic effects - dose dependent and predictable :Type A reactions, which constitute approximatel ...
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Good Manufacturing Practice
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality manageme ...
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Good Clinical Practice
Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research. High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. GCP guidelines include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. GCP guidelines include standards on how ...
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Clinical Study Design
Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research (e.g., epidemiological) involving human beings. The goal of a clinical study is to assess the safety, efficacy, and / or the mechanism of action of an investigational medicinal product (IMP) or procedure, or new drug or device that is in development, but potentially not yet approved by a health authority (e.g. Food and Drug Administration). It can also be to investigate a drug, device or procedure that has already been approved but is still in need of further investigation, typically with respect to long-term effects or cost-effectiveness. Some of the considerations here are shared under the more general topic of design of experiments but there can be others, in particular related to patient confidentiality and ethics. Outline of types of designs for clinical studies Treatment studies * Randomized controlled trial ** Blind trial ...
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Caco-2
Caco-2 (from ''Cancer coli'', "colon cancer") is an immortalized cell line of human colorectal adenocarcinoma cells. It is primarily used as a model of the intestinal epithelial barrier. In culture, Caco-2 cells spontaneously differentiate into a heterogeneous mixture of intestinal epithelial cells. It was developed in 1977 by Jorgen Fogh at the Sloan-Kettering Institute for Cancer Research. History The application of Caco-2 cells in research was pioneered in the late 1980s by Ismael Hidalgo, working in the laboratory of Ron Borchardt at the University of Kansas, and Tom Raub, who was at the Upjohn Company at the time. Following stints at SmithKline Beecham and Rhone-Poulenc Rorer, Hidalgo went on to co-found a company, in 1996, where he currently serves as Senior Vice President of Scientific Affairs. Characteristics Although derived from a colon (large intestine) carcinoma, when cultured under specific conditions the cells become differentiated and polarized such that their p ...
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Biotechnology
Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used by Károly Ereky in 1919, meaning the production of products from raw materials with the aid of living organisms. Definition The concept of biotechnology encompasses a wide range of procedures for modifying living organisms according to human purposes, going back to domestication of animals, cultivation of the plants, and "improvements" to these through breeding programs that employ artificial selection and hybridization. Modern usage also includes genetic engineering as well as cell and tissue culture technologies. The American Chemical Society defines biotechnology as the application of biological organisms, systems, or processes by various industries to learning about the science of life and the improvement of the value of materia ...
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