KIMCo Promotes 'QbD' Support for Global New Drug Development

[Asia Economy Reporter Lee Gwan-joo] The Korea Innovative Medicines Consortium (KIMCo) announced on the 24th that it will promote the 'Pharmaceutical Design-Based Quality Advancement (QbD) Platform Construction Support Project' to support domestic pharmaceutical and bio companies aiming to enter the global market.

QbD is an advanced pharmaceutical manufacturing and quality management method that moves away from the traditional experience-based drug development approach and establishes process design and quality standards based on a scientific understanding of material characteristics and processes.

The project promoted by KIMCo is a new form of QbD support program that combines customized QbD consulting based on actual company projects with in-house expert training. It aims not only to provide one-time result-oriented consulting but also to build and establish a QbD system by providing standard operating procedures (SOPs) for each stage of QbD application.

To this end, KIMCo recently signed a memorandum of understanding (MOU) for strategic partnership with Hangaram Management Innovation Institute. Hangaram Management Innovation Institute is a specialized consulting organization with QbD experts, providing QbD consulting and education to numerous pharmaceutical and bio companies.

Kim Jong-min, CEO of Hangaram Management Innovation Institute, said, “We will do our best to provide QbD strategies for the success of global new drugs by domestic pharmaceutical and bio companies by fully utilizing our accumulated experience and know-how in quality consulting in the pharmaceutical and bio fields.”

Heo Kyung-hwa, CEO of KIMCo, said, “The application of QbD for the creation of global new drugs is now a necessity, not a choice,” adding, “If companies internalize the QbD process and build a system through this project to secure global-level CMC data, it will greatly contribute to the creation of global new drugs.”