Mammalian development and manufacturing services

Lonza Biologics Guangzhou offers you reliable and comprehensive mammalian cell line, process and analytical development services and cGMP production in 1,000L and 2,000L bioreactors. Single-use technologies are employed in both USP and DSP processes. The site supports clinical and commercial production of biotherapeutics and is located 38 km from Guangzhou Baiyun Airport.

Lonza Biologics Guangzhou, China in numbers

thousand m2 site plus significant adjacent expansion land secured
m2 laboratories and pilot plant
m2 cGMP facilities

Development and manufacturing services available

Lonza Biologics Guangzhou is a multiproduct facility for clinical and commercial supply. The site capabilities include single-use bioreactors at 200L, 1,000L and 2,000L and downstream processing equipment. The site will employ Lonza’s current GS Xceed® platform technology. The facility is capable of producing mammalian cell culture therapeutic proteins including monoclonal antibodies, bispecific antibodies, fusion proteins and recombinant enzymes leveraging our global network support.

  • Upstream capabilities
    • Mammalian cell culture processes (CHO, NS0, HEK etc.)
    • cGMP cell banking suite
    • Inoculum train bioreactors capacity from 25L to 500L
    • Production bioreactors of 200L, 500L, 1,000L and 2,000L single-use bioreactors
    • Harvest by depth filtration
    • Pre-packed and loose resin chromatographic columns
    • Viral inactivation
    • Single-use ultrafiltration / diafiltration
    • Bulk filling in to bags
    • Cell line development laboratories
    • Raw material, in-process and final product QC release testing
    • Microbiological testing
    • Drug substance and drug product stability study storage & testing

Our Quality systems and regulatory inspections

Lonza’s global quality system has consistently demonstrated compliance with major global regulators i.e. FDA, EMA, PMDA, ANVISA, TGA. It will also meet China NMPA requirement. The same rigorous quality management systems, documentation practices, training and oversight will be applied to the Lonza Biologics Guangzhou facility to ensure one global quality standard.