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Biotechnology

The use of living organisms or biological systems to create or modify products and processes, such as developing new medicines or crops.

Biopharmaceutical Manufacturing

The process of producing medicines and other health products using biological methods, often involving living cells or organisms.

National Institute of Standards and Technology (NIST)

A federal agency that sets measurement standards and promotes innovation in science and technology.

Good Manufacturing Practices (GMP)

A system of regulations and guidelines that ensures products like medicines are consistently produced and controlled according to quality standards.

Quality by Design (QbD)

A systematic approach to product and process development that starts with predefined objectives and emphasizes product and process understanding to ensure quality.

Chemistry, Manufacturing, and Controls (CMC)

The information submitted to regulatory agencies that describes the manufacturing process, quality testing, and stability of a drug product.

Other Transaction Agreement (OTA)

A type of agreement the government can use to fund research and development, offering more flexibility than traditional contracts or grants.