Leads Biolabs has established a highly integrated and efficient antibody drug development platform including process development (cell culture, protein purification, and FFF), analytical method development, quality control and pilot GMP DS production in Nanjing Biotech and Pharmaceutical Valley.
In compliance with GMP and cGMP, the pilot DS manufacturing facility is equipped with 50L/ 200L/ 500L Single-Use Bioreactor (SUB) and purification devices from Cytiva. The production scale in the plant can be flexibly adjusted to meet the requirements of preclinical pharmacological and toxicological studies, IND filing and phase I/II clinical trials.
Leads’ CMC team is competent to support and undertake the preclinical CMC development, pilot GMP manufacturing (200L or 500L), tech transfer, global IND filing support, process characterization, process validation and BLA filing.