Biomanufacturing is a type of

manufacturing Manufacturing is the creation or production of goods with the help of equipment, labor, machines, tools, and chemical or biological processing or formulation. It is the essence of secondary sector of the economy. The term may refer to a ...

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 b ...

that utilizes biological systems to produce commercially important

biomaterials A biomaterial is a substance that has been engineered to interact with biological systems for a medical purpose, either a therapeutic (treat, augment, repair, or replace a tissue function of the body) or a diagnostic one. As a science, biomateria ...

and

biomolecules A biomolecule or biological molecule is a loosely used term for molecules present in organisms that are essential to one or more typically biological processes, such as cell division, morphogenesis, or development. Biomolecules include larg ...

for use in

medicines 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 re ...

, food and beverage processing, and industrial applications. Biomanufacturing products are recovered from natural sources, such as blood, or from cultures of

microbes A microorganism, or microbe,, ''mikros'', "small") and ''organism'' from the el, ὀργανισμός, ''organismós'', "organism"). It is usually written as a single word but is sometimes hyphenated (''micro-organism''), especially in olde ...

animal cells The cell is the basic structural and functional unit of life forms. Every cell consists of a cytoplasm enclosed within a membrane, and contains many biomolecules such as proteins, DNA and RNA, as well as many small molecules of nutrients and ...

, or

plant cells Plant cells are the cells present in green plants, photosynthetic eukaryotes of the kingdom Plantae. Their distinctive features include primary cell walls containing cellulose, hemicelluloses and pectin, the presence of plastids with the capabi ...

grown in specialized equipment. The cells used during the production may have been naturally occurring or derived using

genetic engineering Genetic engineering, also called genetic modification or genetic manipulation, is the modification and manipulation of an organism's genes using technology. It is a set of technologies used to change the genetic makeup of cells, including ...

techniques.

Products

There are thousands of biomanufacturing products on the market today. Some examples of general classes are listed below:

Medicine

* Amino acids *

Biopharmaceuticals 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, th ...

* Cytokines *

Fusion proteins Fusion proteins or chimeric (kī-ˈmir-ik) proteins (literally, made of parts from different sources) are proteins created through the joining of two or more genes that originally coded for separate proteins. Translation of this ''fusion gene'' r ...

Growth factors 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 re ...

Monoclonal antibodies A monoclonal antibody (mAb, more rarely called moAb) 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. Monoclonal antibodies ...

Vaccines A vaccine is a biological preparation that provides active acquired immunity to a particular infectious or malignant disease. The safety and effectiveness of vaccines has been widely studied and verified.< ...

Food and beverage

* Amino acids * Enzymes * Protein supplements

Industrial applications that employ cells and/or enzymes

* Biocementation *

Bioremediation Bioremediation broadly refers to any process wherein a biological system (typically bacteria, microalgae, fungi, and plants), living or dead, is employed for removing environmental pollutants from air, water, soil, flue gasses, industrial effluent ...

* Detergents *

Plastics Plastics are a wide range of synthetic or semi-synthetic materials that use polymers as a main ingredient. Their plasticity makes it possible for plastics to be moulded, extruded or pressed into solid objects of various shapes. This adaptab ...

Unit operations

A partial listing of unit operations utilized during biomanufacturing includes the following: *

Blood plasma fractionation Blood plasma fractionation are the general processes separating the various components of blood plasma, which in turn is a component of blood obtained through blood fractionation. Plasma-derived immunoglobulins are giving a new narrative to healt ...

* Cell culture * Cell separation, such as

filtration Filtration is a physical separation process that separates solid matter and fluid from a mixture using a ''filter medium'' that has a complex structure through which only the fluid can pass. Solid particles that cannot pass through the filte ...

and

centrifugation Centrifugation is a mechanical process which involves the use of the centrifugal force to separate particles from a solution according to their size, shape, density, medium viscosity and rotor speed. The denser components of the mixture migrate ...

* Fermentation *

Homogenization Homogeneity is a sameness of constituent structure. Homogeneity, homogeneous, or homogenization may also refer to: In mathematics * Transcendental law of homogeneity of Leibniz * Homogeneous space for a Lie group G, or more general transformat ...

Column chromatography Column chromatography in chemistry is a chromatography method used to isolate a single chemical compound from a mixture. Chromatography is able to separate substances based on differential adsorption of compounds to the adsorbent; compounds move t ...

Ultrafiltration Ultrafiltration (UF) is a variety of membrane filtration in which forces such as pressure or concentration gradients lead to a separation through a semipermeable membrane. Suspended solids and solutes of high molecular weight are retained in t ...

and/or

diafiltration Diafiltration is a dilution process that involves removal or separation of components (permeable molecules like salts, small proteins, solvent A solvent (s) (from the Latin '' solvō'', "loosen, untie, solve") is a substance that dissolves a ...

* Clarification, such as

* Formulation * Filling vials or syringes for injectable medicines

Equipment and facilities

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. BTEC Bioreactors

Products manufactured for medical or food use must be produced in facilities designed and operated according to Good Manufacturing Practice (GMP) regulations.

Cleanrooms A cleanroom or clean room is an engineered space, which maintains a very low concentration of airborne particulates. It is well isolated, well-controlled from contamination, and actively cleansed. Such rooms are commonly needed for scientif ...

are often required to control the levels of particulates and microorganisms. Sterilization and

aseptic Asepsis is the state of being free from disease-causing micro-organisms (such as pathogenic bacteria, viruses, pathogenic fungi, and parasites). There are two categories of asepsis: medical and surgical. The modern day notion of asepsis is deriv ...

processing equipment are required for production of

injectable An injection (often and usually referred to as a "shot" in US English, a "jab" in UK English, or a "jag" in Scottish English and Scots) is the act of administering a liquid, especially a drug, into a person's body using a needle (usually a hypod ...

products.

Employment

Skilled professionals are required for positions throughout the life cycle of a biomanufacturing product, which includes: *

Research Research is "creative and systematic work undertaken to increase the stock of knowledge". It involves the collection, organization and analysis of evidence to increase understanding of a topic, characterized by a particular attentiveness t ...

Product development In business and engineering, new product development (NPD) covers the complete process of bringing a new product to market, renewing an existing product or introducing a product in a new market. A central aspect of NPD is product design, along ...

Process development Process simulation is used for the design, development, analysis, and optimization of technical processes such as: chemical plants, chemical processes, environmental systems, power stations, complex manufacturing operations, biological processes, ...

* Preclinical evaluation *

Clinical trials Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...

Engineering Engineering is the use of scientific method, scientific principles to design and build machines, structures, and other items, including bridges, tunnels, roads, vehicles, and buildings. The discipline of engineering encompasses a broad rang ...

Production Production may refer to: Economics and business * Production (economics) * Production, the act of manufacturing goods * Production, in the outline of industrial organization, the act of making products (goods and services) * Production as a stati ...

Supply Chain Management In commerce, supply chain management (SCM) is the management of the flow of goods and services including all processes that transform raw materials into final products between businesses and locations. This can include the movement and sto ...

* Validation * Quality Control * Quality Assurance *

Materials Management Materials management is a core supply chain function and includes supply chain planning and supply chain execution capabilities. Specifically, materials management is the capability firms use to plan total material requirements. The material req ...

Sales Sales are activities related to selling or the number of goods sold in a given targeted time period. The delivery of a service for a cost is also considered a sale. The seller, or the provider of the goods or services, completes a sale in ...

Details for some of these positions are listed in “The Model Employee,” published by the North Carolina Biotechnology Center. In addition, the North Carolina Association for Biomedical Research (NCABR) maintains the website ''About Bioscience'' that offers free online videos on various careers.

Education and training

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