Biomanufacturing (or bioproduction) 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 the secondary sector of the economy. The term may refer ...

biotechnology Biotechnology is a multidisciplinary field that involves the integration of natural sciences and Engineering Science, engineering sciences in order to achieve the application of organisms and parts thereof for products and services. Specialists ...

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. The corresponding f ...

and

biomolecules A biomolecule or biological molecule is loosely defined as a molecule produced by a living organism and essential to one or more typically biological processes. Biomolecules include large macromolecules such as proteins, carbohydrates, lipi ...

for use in

medicines Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, 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 ...

, 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, is an organism of microscopic size, which may exist in its single-celled form or as a colony of cells. The possible existence of unseen microbial life was suspected from antiquity, with an early attestation in ...

animal cells The cell is the basic structural and functional unit of all forms of life. Every cell consists of cytoplasm enclosed within a membrane; many cells contain organelles, each with a specific function. The term comes from the Latin word meaning ...

, 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 capab ...

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 Genetic engineering techniques, technologies used to change the genet ...

techniques.

Products

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

Medicine

Amino acids Amino acids are organic compounds that contain both amino and carboxylic acid functional groups. Although over 500 amino acids exist in nature, by far the most important are the Proteinogenic amino acid, 22 α-amino acids incorporated into p ...

* Biopharmaceuticals *

Cytokines Cytokines () are a broad and loose category of small proteins (~5–25 kDa) important in cell signaling. Cytokines are produced by a broad range of cells, including immune cells like macrophages, B cell, B lymphocytes, T cell, T lymphocytes ...

* Fusion proteins *

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 regu ...

Monoclonal antibodies A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a Lineage (evolution), cell lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Mon ...

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. A vaccine typically contains an ag ...

Food and beverage

Enzymes An enzyme () is a protein that acts as a biological catalyst by accelerating chemical reactions. The molecules upon which enzymes may act are called substrates, and the enzyme converts the substrates into different molecules known as pro ...

* 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 in mycoremediation, and plants in phytoremediation), living or dead, is employed for removing environmental pollutants from air, wate ...

* Detergents *

Plastics Plastics are a wide range of synthetic or semisynthetic materials composed primarily of polymers. Their defining characteristic, plasticity, allows them to be molded, extruded, or pressed into a diverse range of solid forms. This adaptab ...

Unit operations

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

Cell culture Cell culture or tissue culture is the process by which cell (biology), cells are grown under controlled conditions, generally outside of their natural environment. After cells of interest have been Cell isolation, isolated from living tissue, ...

* 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 Fermentation is a type of anaerobic metabolism which harnesses the redox potential of the reactants to make adenosine triphosphate (ATP) and organic end products. Organic molecules, such as glucose or other sugars, are catabolized and reduce ...

* Homogenization *

Column chromatography Column chromatography in chemistry is a chromatography method used to isolate a single chemical compounds, chemical compound from a mixture. Chromatography is able to separate substances based on differential absorption of compounds to the adsorbe ...

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, solvents etc.,) of a solution Solution may refer to: * Solution (chemistry), a mixture where one substance i ...

* 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. 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 that 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 scientifi ...

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 deri ...

processing equipment are required for production of injectable 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 to ...

Product development New product development (NPD) or product development in business and engineering covers the complete process of launching a new product to the market. Product development also includes the renewal of an existing product and introducing a product ...

* Process development * Preclinical evaluation *

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

Engineering Engineering is the practice of using natural science, mathematics, and the engineering design process to Problem solving#Engineering, solve problems within technology, increase efficiency and productivity, and improve Systems engineering, s ...

* Production *

Supply Chain Management In commerce, supply chain management (SCM) deals with a system of procurement (purchasing raw materials/components), operations management, logistics and marketing channels, through which raw materials can be developed into finished produc ...

* Validation *

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 plac ...

Quality Assurance Quality assurance (QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to assure that the product(s) delivered to customer(s) meet with the contractual and other agreed upon performance, design ...

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 re ...

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. A period during which goods are sold for a reduced price may also be referred ...

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 Golden LEAF Biomanufacturing Training and Education Center (BTEC) at

North Carolina State University North Carolina State University (NC State, North Carolina State, NC State University, or NCSU) is a public university, public Land-grant university, land-grant research university in Raleigh, North Carolina, United States. Founded in 1887 and p ...

, (BRITE) at

North Carolina Central University North Carolina Central University (NCCU or NC Central) is a Public university, public Historically black colleges and universities, historically black university in Durham, North Carolina, United States. Founded by James E. Shepard in affiliati ...

, and North Carolina Community College System’s BioNetwork operate multidisciplinary centers dedicated to workforce development for the biomanufacturing industry.
MiraCosta College
an
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.

References

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External links

NCBioImpact

Biomanufacturing Research Institute and Technology Enterprise (BRITE)

BioNetwork

Golden LEAF Biomanufacturing Training and Education Center (BTEC)

North Carolina Biotechnology Center

North Carolina Association for Biomedical Research (NCABR)

About Bioscience
Biotechnology Biopharmaceuticals Food industry Life sciences industry Industrial processes Drug manufacturing