BIOMANUFACTURING Photo from Flickr.com

What is Biomanufacturing? Biomanufacturing/Bioprocessing: A procedure in which living cells or parts of the cell are used to produce a desired end product. (Ex. Flu Shot) “It’s how a child’s measles vaccine and the supplement in an athlete’s protein shake are produced. “ Quote from www.ncbiotech.org

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

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

What are some examples of Biomanufacturing in N.C.? Types of products made in N.C. include: Vaccines for humans and animals Yearly shots & Rabies Biopharmaceuticals Medicines Industrial enzymes Contact Lens solution & Laundry detergents w stain fighters Graphic from www.ncbiotech.org

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.

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.

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.

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

Batch record components The identity of the employees performing and checking each step. Signature log Print name Signature Initial Date

Batch record components Materials Used Item # Item description Quantity required Weighed by: Initial/date Identifying information 5.1 Kool-Aid Mix 1.0 g _____/______ 5.2 Granulated Sugar 60 g 5.3 Water 1000 mL

Batch record components Equipment Log Item # Item description Quantity required Collected by: Initial/Date Identifying Information 5.4 2000 mL Pitcher 1 _____/______ 5.5 Long handle spoon 5.6 Scale

Batch record components Procedure Step # Task Amount/ Weight Performed by: initial/date 6.1 Weigh the Kool-Aid powder using the electronic scale. _____/____ 6.2 Weigh the granulated sugar using the electronic scale. 6.3 Fill container with 1000mL of water using the markings on the container. _____/_____ 6.4 Add the Kool-Aid powder and sugar to the container. 6.5 Use the spoon to stir the mixture until no solid material (sugar or Kool-Aid powder) is visible at the bottom of the container. 6.6 Secure the lid on the top of the container.

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 (ex. viox) -Company shutdowns and loss of jobs

How to Use A Digital Scale Make sure you select the proper measurements for your lab. (grams) Put your weighing boat on scale and ZERO OUT. SLOWLY add the material you are weighing until you get to the correct amount. Leave scale & work area neat and clean!

Who is your Supervisor? In your home? In the workplace? In our class/lab?

All Equipment is labeled! You are responsible for cleaning your equipment and table after lab is complete. All spoons and containers are labeled by table.