"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."
The use of living organisms such as bacteria to create products.
Introduction to Biomanufacturing: Provides an overview of biomanufacturing processes and their applications in biomedical engineering.
Bioprocessing: Processes that include fermentation, purification, filtration, and sterilization that are used to produce pharmaceuticals and biochemicals.
Bioreactor Design and Scale-Up: The process of scaling up bioreactors for industrial production, correlating the design to meet the functional requirements of specific applications.
Microbial Cultures: An in-depth study of bacteria, fungi and yeast. Normally, the use of microbes in the creation of products ranging from beer, cheese, and yogurt to various types of pharmaceuticals.
Upstream and Downstream Processing: Breaks down processes from upstream processes dealing with raw materials to downstream processes that narrow down or enrich specific constituents in the final product.
Gene cloning and expression: The process of isolating, purifying, and amplifying genes, creating recombinant DNA, and expressing synthetic gene sequences in bacterial and animal cells.
Biomanufacturing Quality Control: The development of analytical methods and control steps used to ensure product quality and consistency in the biomanufacturing process.
Process Validation and qualification: Verification that a manufacturing process will reproduce the same product with the same quality and consistency, and compliance with the regulatory framework of worldwide goods.
Regulatory Compliance: Complying with government regulations and guidelines to help ensure that products are safe, reliable, and consistent.
Manufacturing Information System (MIS): The implementation and operation of information systems to monitor manufacturing operations and assist the biomanufacturing process stakeholders to make informed decisions.
Upstream Processing: Upstream processing involves the growth and maintenance of cells or microorganisms used to produce biologics. It includes processes like cell culture, fermentation, media preparation, and cell banking.
Downstream Processing: Downstream processing refers to the purification and separation of the biological products from the cells or microorganisms. This includes processes like filtration, chromatography, extraction, and ultrafiltration.
Cell Line Development: Cell line development involves the creation and screening of stable, high-producing cell lines that will be used for biologics production in the future.
Formulation: Formulation is the process of combining the purified biological product with other ingredients like preservatives, stabilizers, and buffers to create a final, marketable product.
Fill and Finish: Fill and finish involves the sterile filling of the final product into its packaging, such as vials or syringes, and ensuring that it meets all necessary quality standards.
Analytical Testing: Analytical testing involves the characterization and quality control testing of both the biological product and its raw materials throughout the manufacturing process.
Contract Manufacturing: Contract manufacturing involves outsourcing the biomanufacturing process to a third-party company that specializes in biologics production.
Biosimilars Manufacturing: Biosimilars are biological products that are highly similar to existing, approved biologics. Biosimilars manufacturing involves the production of these products following a similar process to the original biologic.
Personalized Medicine Manufacturing: Personalized medicine involves the creation of medical treatments tailored to an individual’s specific genetic makeup or medical history. Personalized medicine manufacturing involves the production of these customized treatments.
Gene Therapy Manufacturing: Gene therapy involves the use of genetic material to treat or prevent diseases. Gene therapy manufacturing involves the production of these gene-based treatments.
"Biomanufacturing products are used 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."
"Biomanufacturing is used to produce commercially important biomaterials and biomolecules."
"Biomanufacturing is used to produce biomaterials and biomolecules for food and beverage processing."
"Biomanufacturing is used to produce biomaterials and biomolecules for medicines."
"Biomanufacturing is a type of manufacturing or biotechnology that utilizes biological systems, whereas traditional manufacturing does not."
"Plant cells are grown in specialized equipment during biomanufacturing."
"Biomaterials produced through biomanufacturing include those used in medicines and industrial applications."
"Cultures of microbes, animal cells, or plant cells are grown in specialized equipment for biomanufacturing."
"Yes, the cells used in biomanufacturing may have been derived using genetic engineering techniques."
"Biomanufacturing allows for the production of commercially important biomaterials and biomolecules."
"The paragraph does not directly address limitations of biomanufacturing."
"Biomanufacturing is used to produce biomaterials and biomolecules for industrial applications."
"Biomanufacturing utilizes biological systems to produce biomaterials and biomolecules."
"Biomanufacturing products are recovered from natural sources, such as blood."
"The paragraph does not mention the production of biofuels through biomanufacturing."
"Yes, biomanufacturing products are recovered from cultures of microbes, animal cells, or plant cells."
"The paragraph does not directly address the development of new products through biomanufacturing."