Biomanufacturing (or bioproduction) 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.[ citation needed ]
There are thousands of biomanufacturing products on the market today. Some examples of general classes are listed below:
A partial listing of unit operations utilized during biomanufacturing includes the following:
Equipment and facility requirements are dictated by the product(s) being manufactured. Process equipment is typically constructed of stainless steel or plastic. Stainless steel equipment can be cleaned and reused. Some plastic equipment is disposed of after a single use.
Products manufactured for medical or food use must be produced in facilities designed and operated according to Good Manufacturing Practice (GMP) regulations. Cleanrooms are often required to control the levels of particulates and microorganisms. Sterilization and aseptic processing equipment are required for production of injectable products.
Skilled professionals are required for positions throughout the life cycle of a biomanufacturing product, which includes:
Details for some of these positions are listed in “The Model Employee,” published by the North Carolina Biotechnology Center. [1] In addition, the North Carolina Association for Biomedical Research (NCABR) maintains the website About Bioscience that offers free online videos on various careers. [2]
Several academic institutions have developed curricula and built facilities to provide education and training in biomanufacturing to students from community colleges, universities, and/or industry. NCBioImpact, established in 2004, is an example of a comprehensive state-wide training network. Member institutions Golden LEAF Biomanufacturing Training and Education Center (BTEC) at North Carolina State University, (BRITE) at North Carolina Central University, and North Carolina Community College System’s BioNetwork operate multidisciplinary centers dedicated to workforce development for the biomanufacturing industry.
MiraCosta College and Solano College in California developed the first bachelor of science degree in biomanufacturing. The degree is largely lab-based and is built on a contextualized science and statistics backbone. The upper division classes recognize the unique environment of biological production where the process sciences and technology thrive in partnership with quality and regulatory compliance.
Biomedical engineering (BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare applications. BME is also traditionally logical sciences to advance health care treatment, including diagnosis, monitoring, and therapy. Also included under the scope of a biomedical engineer is the management of current medical equipment in hospitals while adhering to relevant industry standards. This involves procurement, routine testing, preventive maintenance, and making equipment recommendations, a role also known as a Biomedical Equipment Technician (BMET) or as a clinical engineer.
Biochemical engineering, also known as bioprocess engineering, is a field of study with roots stemming from chemical engineering and biological engineering. It mainly deals with the design, construction, and advancement of unit processes that involve biological organisms or organic molecules and has various applications in areas of interest such as biofuels, food, pharmaceuticals, biotechnology, and water treatment processes. The role of a biochemical engineer is to take findings developed by biologists and chemists in a laboratory and translate that to a large-scale manufacturing process.
BTEC may refer to:
Freeze drying, also known as lyophilization or cryodesiccation, is a low temperature dehydration process that involves freezing the product and lowering pressure, thereby removing the ice by sublimation. This is in contrast to dehydration by most conventional methods that evaporate water using heat.
Metallic fibers are manufactured fibers composed of metal, metallic alloys, plastic-coated metal, metal-coated plastic, or a core completely covered by metal.
Ventria Bioscience is a biotech company with a focus on human nutrition and human therapeutics. The company was established in 1993 in Colorado. The company's core technology is a genetically modified crop-based protein production system called ExpressTec. They have also made applications to grow rice with human genes.
Blow-Fill-Seal, also spelled as Blow/Fill/Seal, in this article abbreviated as BFS, is an automated manufacturing process by which plastic containers, such as bottles or ampoules are, in a continuous operation, blow-formed, filled, and sealed. It takes place in a sterile, enclosed area inside a machine, without human intervention, and thus can be used to aseptically manufacture sterile pharmaceutical or non-pharmaceutical liquid/semiliquid unit-dosage forms. BFS is an advanced aseptic processing technology that is typically used for filling and packaging of certain sterile liquid formulations like liquid ophthalmics, inhalational anesthetics, or lavaging agents, but can also be used for injectables, parenteral medicines, and several other liquid or semiliquid medications, with fill volumes ranging from 0.1...1000 cm³. Compared against traditional glass ampoules, BFS ampoules are inexpensive, lightweight, and shatterproof.
A bioprocess is a specific process that uses complete living cells or their components to obtain desired products.
In chemistry, fine chemicals are complex, single, pure chemical substances, produced in limited quantities in multipurpose plants by multistep batch chemical or biotechnological processes. They are described by exacting specifications, used for further processing within the chemical industry and sold for more than $10/kg. The class of fine chemicals is subdivided either on the basis of the added value, or the type of business transaction, namely standard or exclusive products.
Centennial Campus is a research park and educational campus owned and operated by North Carolina State University in Raleigh, North Carolina, United States. Composed of two locations, the 1,334 acres (5.4 km2) property provides office and lab space for corporate, governmental and not-for-profit entities, in addition to providing space for 75 university research centers, institutes, laboratories and departmental units. Currently, 5,000,000 sq ft (460,000 m2) of constructed space has been built. Upon completion, Centennial Campus is anticipated to have 9,000,000 sq ft (840,000 m2) of constructed space.
A biosand filter (BSF) is a point-of-use water treatment system adapted from traditional slow sand filters. Biosand filters remove pathogens and suspended solids from water using biological and physical processes that take place in a sand column covered with a biofilm. BSFs have been shown to remove heavy metals, turbidity, bacteria, viruses and protozoa. BSFs also reduce discoloration, odor and unpleasant taste. Studies have shown a correlation between use of BSFs and a decrease in the occurrence of diarrhea. Because of their effectiveness, ease of use, and lack of recurring costs, biosand filters are often considered appropriate technology in developing countries. It is estimated that over 200,000 BSFs are in use worldwide.
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.
The Golden LEAF Foundation is a nonprofit corporation based in Rocky Mount, North Carolina in the United States, that was created in 1999 to receive half of the funds coming to North Carolina from the master settlement agreement with cigarette manufacturers. The foundation is now devoted to advancing the economic well being of North Carolinians and to transforming its economy. It works in partnership with local governments, educational institutions, economic development organizations and other public agencies, and nonprofits to achieve this goal.
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.
Eurogentec is a biotechnology supplier, based in Belgium, that specializes in genomics and proteomics kits, reagents, and certain biologics. It was founded in 1985 as a spin-off from the University of Liège. Eurogentec operates two licensed contract manufacturing organization facilities in Belgium which produce custom biologic and oligonucleotide products mainly for European pharmaceutical companies, but also holds a license from the U.S. FDA to export a commercial protein product to the U.S.. These products are used to diagnose and treat various conditions.
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).
Bioproducts engineering or bioprocess engineering refers to engineering of bio-products from renewable bioresources. This pertains to the design and development of processes and technologies for the sustainable manufacture of bioproducts from renewable biological resources.
NCBioImpact is a group of organizations in the U.S. state of North Carolina created to enhance the trained workforce for biotechnology and other life science employers by educating students and retraining incumbent workers. The partnership works to promote economic development in North Carolina while offering comprehensive biomanufacturing training and education programs located at two universities in the University of North Carolina System and the North Carolina Community College System.
Arven Pharmaceuticals is a Turkish pharmaceutical corporation headquartered in Istanbul established as a subsidiary of Toksöz Group in 2013. Arven's primary focus is development and production of high-technology inhaler and biotechnology products. The company is specialized on difficult to make products. Arven is the first Turkish company developing biosimilars for global markets, including the US and EU.