Biomanufacturing

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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. 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.[ citation needed ]

Contents

Products

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

Medicine

Food and beverage

Industrial applications that employ cells and/or enzymes

Unit operations

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

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.

Stainless Steel Bioreactors BTEC Bioreactors.jpg
Stainless Steel Bioreactors

Products manufactured for medical or food use must be produced in facilities designed and operated according to Good Manufacturing Practice (GMP) regulations. Cleanrooms are often required to control the levels of particulates and microorganisms. Sterilization and aseptic 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:

Details for some of these positions are listed in “The Model Employee,” published by the North Carolina Biotechnology Center. [1] In addition, the North Carolina Association for Biomedical Research (NCABR) maintains the website About Bioscience that offers free online videos on various careers. [2]

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, (BRITE) at North Carolina Central University, and North Carolina Community College System’s BioNetwork operate multidisciplinary centers dedicated to workforce development for the biomanufacturing industry.

MiraCosta College and 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.

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<span class="mw-page-title-main">Centennial Campus of North Carolina State University</span>

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<span class="mw-page-title-main">Golden LEAF Biomanufacturing Training and Education Center</span>

The Golden LEAF Biomanufacturing Training and Education Center (BTEC) is a multidisciplinary instructional center at North Carolina State University that provides education and training to develop skilled professionals for the biomanufacturing industry. Biomanufacturing refers to the use of living organisms or other biological material to produce commercially viable products. Examples include therapeutic proteins, monoclonal antibodies, and vaccines for medical use; amino acids and enzymes for food manufacturing; and biofuels and biochemicals for industrial applications. BTEC provides hands-on education and training in bioprocessing concepts and biomanufacturing methods that comply with cGMP (current Good Manufacturing Practice), a set regulations published by the United States Food and Drug Administration (FDA).

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NCBioImpact is a group of organizations in the U.S. state of North Carolina created to enhance the trained workforce for biotechnology and other life science employers by educating students and retraining incumbent workers. The partnership works to promote economic development in North Carolina while offering comprehensive biomanufacturing training and education programs located at two universities in the University of North Carolina System and the North Carolina Community College System.

<span class="mw-page-title-main">Arven Pharmaceuticals</span>

Arven Pharmaceuticals is a Turkish pharmaceutical corporation headquartered in Istanbul established as a subsidiary of Toksöz Group in 2013. Arven’s primary focus is development and production of high-technology inhaler and biotechnology products. The company is specialized on difficult to make products. Arven is the first Turkish company developing biosimilars for global markets, including the US and EU.

References

  1. "The Model Employee" (PDF). ncbiotech.org.
  2. "About Bioscience". www.ncabr.org.