Alteogen Establishes Quality Division in Preparation for Pipeline Commercialization

Bio company Alteogen announced on the 7th that it has established a Quality Division ahead of the commercialization of each pipeline. This is due to the increasing importance of production and quality as both the licensed human hyaluronidase (ALT-B4) and the Eylea biosimilar (ALT-L9) have entered global Phase 3 clinical trials, moving closer to commercialization.

At the end of May, Alteogen established the Quality Division to transition to a specialized GMP system, integrating the previously separate QA (Quality Assurance) and QC (Quality Control) teams into a single division. The goal is to create synergy in commercial production through this integration.

An Alteogen official stated, "The importance of quality-related departments is growing, from GMP technology transfer and preparation of technical documents for product approval in preparation for mass production, to continuous quality management after commercialization." He added, "Through the integration of the Quality Division, we expect smoother management and synergy in overlapping areas between the two organizations." Furthermore, they are strengthening their workforce by recruiting personnel with extensive experience in production and quality from various pharmaceutical and bio companies to reduce trial and error and enhance the capabilities of their members.

Currently, Alteogen received milestones in April for the partner company's entry into Phase 3 clinical trials of human hyaluronidase and QA at the cGMP level. In addition, at the end of May, they invoiced a $3 million milestone related to the development progress of the human hyaluronidase licensed to Sandoz AG, one of the global big pharma companies, demonstrating continuous platform technology licensing and progress toward productization.

This content was produced with the assistance of AI translation services.