A monoclonal antibody is an antibody produced from a cell lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell.
A bioreactor refers to any manufactured device or system that supports a biologically active environment. In one case, a bioreactor is a vessel in which a chemical process is carried out which involves organisms or biochemically active substances derived from such organisms. This process can either be aerobic or anaerobic. These bioreactors are commonly cylindrical, ranging in size from litres to cubic metres, and are often made of stainless steel. It may also refer to a device or system designed to grow cells or tissues in the context of cell culture. These devices are being developed for use in tissue engineering or biochemical/bioprocess engineering.
Pharming, a portmanteau of "farming" and "pharmaceutical", refers to the use of genetic engineering to insert genes that code for useful pharmaceuticals into host animals or plants that would otherwise not express those genes, thus creating a genetically modified organism (GMO). Pharming is also known as molecular farming, molecular pharming or biopharming.
A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine.
Industrial fermentation is the intentional use of fermentation in manufacturing processes. In addition to the mass production of fermented foods and drinks, industrial fermentation has widespread applications in chemical industry. Commodity chemicals, such as acetic acid, citric acid, and ethanol are made by fermentation. Moreover, nearly all commercially produced industrial enzymes, such as lipase, invertase and rennet, are made by fermentation with genetically modified microbes. In some cases, production of biomass itself is the objective, as is the case for single-cell proteins, baker's yeast, and starter cultures for lactic acid bacteria used in cheesemaking.
Downstream processing refers to the recovery and the purification of biosynthetic products, particularly pharmaceuticals, from natural sources such as animal tissue, plant tissue or fermentation broth, including the recycling of salvageable components as well as the proper treatment and disposal of waste. It is an essential step in the manufacture of pharmaceuticals such as antibiotics, hormones, antibodies and vaccines; antibodies and enzymes used in diagnostics; industrial enzymes; and natural fragrance and flavor compounds. Downstream processing is usually considered a specialized field in biochemical engineering, which is itself a specialization within chemical engineering. Many of the key technologies were developed by chemists and biologists for laboratory-scale separation of biological and synthetic products, whilst the role of biochemical and chemical engineers is to develop the technologies towards larger production capacities.
Miranda Gek Sim Yap, also abbreviated as M.Yap or MGS Yap, was a professor in the Chemical and Biomolecular Engineering Department of the National University of Singapore, and the Executive Director of the Bioprocessing Technology Institute at the Agency for Science, Technology and Research of Singapore (A*STAR).
Expanded bed adsorption (EBA) is a preparative chromatographic technique which makes processing of viscous and particulate liquids possible.
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 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 based on using living cells or sub component of such cells.
Fed-batch culture is, in the broadest sense, defined as an operational technique in biotechnological processes where one or more nutrients (substrates) are fed (supplied) to the bioreactor during cultivation and in which the product(s) remain in the bioreactor until the end of the run. An alternative description of the method is that of a culture in which "a base medium supports initial cell culture and a feed medium is added to prevent nutrient depletion". It is also a type of semi-batch culture. In some cases, all the nutrients are fed into the bioreactor. The advantage of the fed-batch culture is that one can control concentration of fed-substrate in the culture liquid at arbitrarily desired levels.
Acetone–butanol–ethanol (ABE) fermentation, also known as the Weizmann process, is a process that uses bacterial fermentation to produce acetone, n-butanol, and ethanol from carbohydrates such as starch and glucose. It was developed by chemist Chaim Weizmann and was the primary process used to produce acetone, which was needed to make cordite, a substance essential for the British war industry during World War I.
Merck Millipore was the brand used by Merck Group's global life science business until 2015 when the company re-branded. It was formed when Merck acquired the Millipore Corporation in 2010. Merck is a supplier to the life science industry. The Millipore Corporation was founded in 1954, and listed among the S&P 500 since the early 1990s, as an international biosciences company which makes micrometer pore-size filters and tests. In 2015, Merck acquired Sigma-Aldrich and merged it with Merck Millipore. In the United States and Canada, the life science business is now known as MilliporeSigma.
Sartorius AG is an international pharmaceutical and laboratory equipment supplier, covering the segments of Bioprocess Solutions and Lab Products & Services. In September 2021, Sartorius has been admitted to the DAX, Germany's largest stock market index. As a leading partner to the biopharmaceutical research and industry, Sartorius supports its customers in the development and production of biotech drugs and vaccines - from the initial idea in the laboratory to commercial production. Sartorius conducts its operating business in the two divisions Bioprocess Solutions and Lab Products&Services. The divisions bundle their respective businesses according to the same application areas and customer groups. The divisions share some of the infrastructure and central services.
A single-use bioreactor or disposable bioreactor is a bioreactor with a disposable bag instead of a culture vessel. Typically, this refers to a bioreactor in which the lining in contact with the cell culture will be plastic, and this lining is encased within a more permanent structure. Commercial single-use bioreactors have been available since the end of the 1990s and are now made by several well-known producers.
The Golden LEAF Biomanufacturing Training and Education Center (BTEC) is a multidisciplinary instructional center at North Carolina State University that provides education and training to develop skilled professionals for the biomanufacturing industry. Biomanufacturing refers to the use of living organisms or other biological material to produce commercially viable products. Examples include therapeutic proteins, monoclonal antibodies, and vaccines for medical use; amino acids and enzymes for food manufacturing; and biofuels and biochemicals for industrial applications. BTEC provides hands-on education and training in bioprocessing concepts and biomanufacturing methods that comply with cGMP (current Good Manufacturing Practice), a set regulations published by the United States Food and Drug Administration (FDA).
Bioproduction is the production of biologics-based therapeutic drugs including protein-based therapeutics, vaccines, gene therapies as well as cell therapies; drugs so complex they can only be made in living systems or indeed are a living system. In practice, ‘bioproduction’ has become loosely synonymous with ‘bioprocessing’ as a way to describe the manufacturing process using, cell culture, chromatography, formulation and related analytical testing for large molecule drugs, vaccines and cellular therapies. Many combinations of reactor types and culture modes are now available for use in bioproduction: e.g., pharming, rocking wave-agitated bag batch, stirred-tank or air-lift fed-batch, and hollow-fiber or spin-filter perfusion. No single production format is inherently superior; that determination depends on many manufacturing capabilities, requirements, and goals. New cell lines, concerns about product quality and safety, emerging biosimilars, worldwide demand for vaccines, and cellular medicine drive new innovative solutions in bioproduction.
Biomanufacturing is a type of manufacturing or biotechnology that utilizes biological systems to produce commercially important biomaterials and biomolecules for use in medicines, food and beverage processing, and industrial applications. Biomanufacturing products are recovered from natural sources, such as blood, or from cultures of microbes, animal cells, or plant cells grown in specialized equipment. The cells used during the production may have been naturally occurring or derived using genetic engineering techniques.
Wei-Shou Hu is a Taiwanese-American chemical engineer. He earned his B.S. in agricultural chemistry from National Taiwan University in 1974 and his Ph.D. in biochemical engineering from the Massachusetts Institute of Technology under the guidance of Daniel I.C. Wang in 1983. He has been a professor with the University of Minnesota since 1983. Dr. Hu has long impacted the field of cell culture bioprocessing since its infancy by steadfastly introducing quantitative and systematic analysis into this field. His work, which covers areas such as modeling and controlling cell metabolism, modulating glycosylation, and process data mining, has helped shape the advances of biopharmaceutical process technology. He recently led an industrial consortium to embark on genomic research on Chinese hamster ovary cells, the main workhorse of biomanufacturing, and to promote post-genomic research in cell bioprocessing. His research focuses on the field of cell culture bioprocessing, particularly metabolic control of the physiological state of the cell. In addition to his work with Chinese hamster ovary cells, his work has enabled the use of process engineering for cell therapy, especially with liver cells. Dr.Hu has written four different biotechnology books. Also, one of his articles is cited by 63.
Host cell proteins (HCPs) are process-related protein impurities that are produced by the host organism during biotherapeutic manufacturing and production. During the purification process, a majority of produced HCPs are removed from the final product. However, residual HCPs still remain in the final distributed pharmaceutical drug. Examples of HCPs that may remain in the desired pharmaceutical product include: monoclonal antibodies (mAbs), antibody-drug-conjugates (ADCs), therapeutic proteins, vaccines, and other protein-based biopharmaceuticals.
