Biomanufacturing

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Biomanufacturing produces a wide range of biobased products for the emerging global bioeconomy. Biomanufacturing begins with bioprospecting – the discovery and commercialization of new products based on biologic resources. Biomanufacturing requires knowledge and methods from many scientific disciplines including biology, microbiology, biotechnology, chemistry, physics, engineering and technology. It includes genetic engineering and metabolic engineering plus various cell and tissue culture technologies.

Biomanufactured products range from biopharmaceuticals to industrial enzymes, human tissues and replacement organs, biofuels, ‘green’ chemicals and green products to replace those derived from petroleum. The application of biotechnology to industrial manufacturing is not only transforming how we develop and produce products, it's also generating new ideas - such as using microalgae to scrub power plant effluent gases and process water while making biofuels to help run the power plant at the same time. Another example is anaerobically turning cow manure and other wastes into gases to make electricity.

Every job in a biomanufacturing enterprise must combine in a unified effort to build quality into each phase of making the product. Everyone involved shares the same goal: achieve the highest quality product on a consistent basis. Commonly held skill standards and protocols establish and maintain this state of thorough control. The Food and Drug Administration’s current Good Manufacturing Practices (cGMP), outlined in CFR 210 and 211, are used to create repeatable standard operating procedures (SOPs) that can be validated to make sure manufactured products always have consistent quality. Teams develop methods for effectively monitoring production performance. Together, they analyze samples to evaluate each step and continually improve goal attainment.

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