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BIOMANUFACTURING

BIOMANUFACTURING. Photo from Flickr.com. What is Biomanufacturing?. Biomanufacturing/Bioprocessing: A procedure in which microorganisms, living cells or their components are used to produce a desired end product.

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BIOMANUFACTURING

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  1. BIOMANUFACTURING Photo from Flickr.com

  2. What is Biomanufacturing? Biomanufacturing/Bioprocessing: A procedure in which microorganisms, living cells or their components are used to produce a desired end product. “It’s how a child’s measles vaccine and the supplement in an athlete’s protein shake are produced. “ Quote from www.ncbiotech.org

  3. BIOMANUFACTURING Biomanufacturing is also known as bioprocessing. People who work in this field need to know Biology, Engineering, and Manufacturing technology. Career Pathways: Biotechnology

  4. Fermentation: A process of growing microorganisms (microbes) to produce various chemical or pharmaceutical compounds. How do the microbes grow? Microbes are usually incubated under specific conditions in large tanks called fermenters or bioreactors.

  5. What are some examples of Biomanufacturing in N.C.? Types of products made in N.C. include: • Vaccines for humans and animals • Biopharmaceuticals • Amino acids • Industrial enzymes • Custom DNA sequences • Therapeutics isolated from blood Graphic from www.ncbiotech.org

  6. How do Biotech companies ensure safe and Quality Products? • Good Manufacturing Practices (GMP) are regulations established by the U.S. Food and Drug Administration (FDA). GMP regulations describe the methods, equipment, facilities, and controls required for producing pharmaceutical products.

  7. How do Biotech companies ensure safe and Quality Products? • Standard operating procedure (SOP): A document that defines in detail every step of only one particular process so it can be performed exactly the same way every time. In biomanufacturing, there are SOPs for every single step of the process; for example, the correct way to put on a gown before entering the production area.

  8. SOPs ~ Standard operating procedures • Standard Operating Procedures are like recipes. A recipe is also a set of directions, that when followed, will result in a particular dish or “batch” of something.

  9. Batch records Batch record: Documentation that each step in the manufacturing process was completed; it includes very detailed information, such as: • Signature Log • Materials Used • Equipment Log • Procedures

  10. Batch record components The identity of the employees performing and checking each step. Signature log

  11. Batch record components Materials Used

  12. Batch record components Equipment Log

  13. Batch record components Procedure

  14. Why are GMP and SOPS important? Some Biomanufacturing facilities in NC make batches of product worth millions of dollars. Their employees are responsible for the production of each batch and for helping to ensure its quality by taking samples for testing. If batches are not made properly, the consequences can be serious and costly: -Lost profit due to bad/discarded batches -Loss of customers due to bad product or publicity -Sick, injured or deceased customers -Lawsuits -Company shutdowns and loss of jobs

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