Research Article
Advancements and Challenges in Quality Assurance for Biopharmaceuticals: Ensuring Safety and Efficacy
@INPROCEEDINGS{10.4108/eai.13-11-2024.2355691, author={Likitha AR and K Selvakumar}, title={Advancements and Challenges in Quality Assurance for Biopharmaceuticals: Ensuring Safety and Efficacy}, proceedings={Proceedings of the 1st International Conference on Frontiers in Physical and Chemical Sciences: Exploring New Horizons, FPCS 2024, 13-14 November 2024, Bengaluru, Karnataka, India}, publisher={EAI}, proceedings_a={FPCS}, year={2025}, month={8}, keywords={quality by design (qbd) process analytical technology (pat) biopharmaceutical manufacturing regulatory compliance}, doi={10.4108/eai.13-11-2024.2355691} }- Likitha AR
K Selvakumar
Year: 2025
Advancements and Challenges in Quality Assurance for Biopharmaceuticals: Ensuring Safety and Efficacy
FPCS
EAI
DOI: 10.4108/eai.13-11-2024.2355691
Abstract
The rapid expansion of the biopharmaceutical industry, driven by the demand for biologics, biosimilars, and personalized medicine, has introduced new complexities in ensuring product safety, efficacy, and quality. Biopharmaceuticals differ from small-molecule drugs in their intricate manufacturing processes and biological nature, making quality assurance (QA) a critical aspect of their production. This review discusses key advancements in biopharmaceutical QA, including the implementation of Quality by Design (QbD), Process Analytical Technology (PAT), and automation technologies. Additionally, it explores challenges such as process variability, contamination risks, regulatory compliance, and the complexity of biosimilar development. As the industry embraces emerging trends such as personalized medicine and continuous manufacturing, innovative QA strategies will be essential to maintaining product quality.
