- Qurgen has successfully GMP manufactured SON-DP, Lot 4 using Qurgen’s own new GMP facility at Qurgen’s subsidiary company: FUENT Pharmaceutics in Suzhou, China. The quality parameters of the newly manufactured SON-DP are either the same or better than our previous 3 Lots of GMP-manufactured SON-DP. The overall quality of all 4 Lots of GMP manufactured SON-DP meets the FDA quality standard of protein drug. With this first manufacture of SON-DP, the Qurgen CMC team is working on optimization of the manufacture SOPs with the hope to increase the lot yield by THREE times in 2025 as comparison with the yield of Lot 4. With three-time yield increase in the GMP manufactured SON-DP, the cost of the drug should be significantly reduced.
