Which branch in biotechnology tests biopharmaceutical products for safety and potency?

Quality Control is the branch in biotechnology that specifically focuses on testing biopharmaceutical products for safety and potency. This area is essential in ensuring that the products meet the established specifications and quality standards before they are released for use. Quality Control involves a variety of analytical tests and methods to assess the biological activity, stability, and contamination levels of therapeutic products.

In this context, safety pertains to the assurance that the products do not produce harmful effects when administered, while potency ensures that the biopharmaceuticals deliver the intended therapeutic effect. Through rigorous testing protocols, Quality Control helps to maintain product integrity and compliance with regulatory requirements, thereby safeguarding patient health.

Quality Assurance, while related, deals more with the processes and systems put in place to ensure that quality is maintained throughout the production process, rather than direct testing of the products themselves. Regulatory Affairs focuses on navigating the regulatory landscape and ensuring that products comply with laws and standards, but does not directly test biopharmaceuticals. Clinical Development entails the structured testing of new drugs in human subjects to evaluate their efficacy and safety, which is a different phase from the final quality testing of the biopharmaceutical products.