Lonza says the expansion of its high potency API facility in Nansha, China will help support growing demand for ADC production.
Swiss contract development manufacturing organization (CDMO) Lonza will add three 1,000 L GMP trains, including development laboratories with the capacity to produce small scale batches of highly potent APIs (HPAPIs).
The expanded site will also boast six 1,000 L small molecule reactors, four 1,500L vessels, and isolation equipment adding capacity for a smooth transition between early-phase and large-scale commercial production.
As well as APIs ‚Äúthe expansion in Nansha can indeed be connected to antibody-drug conjugates (ADCs) intermediates and final linkers, which will be developed and manufactured at this facility,‚ÄĚ a spokeswoman for Lonza told BioProcess Insider.
The ADC market has expanded considerably over the years.
There are now 11 ADCs approved by the US Food and Drug Administration (FDA) and dozens more in clinical trials.
Lonza told us the increase in authorized ADCs ‚Äúhas driven investments in all elements of the ADC: antibody development and production, payload development and production, linker development and production, and conjugation to assemble the ADC.‚ÄĚ
The expanded manufacturing facility at Nansha is anticipated to be fully operational between Q1 2022 and Q3 2022 and Lonza expects the site to create approximately 70 new jobs.
This is not Lonza‚Äôs first manufacturing plant in China. The CDMO also has a mammalian facility located in Guangzhou, which has been fully operational since Q1 2021.
‚ÄúChina represents the second-largest pharmaceuticals market globally,‚ÄĚ the spokeswoman said.
She added: ‚ÄúThe market is estimated to grow to $145-175 billion in 2022. Currently, many global pharmaceutical companies are investing in innovative R&D approaches, digitalization, and innovative drug formats and complex modalities in CN and conduct clinical trials in China.
‚ÄúHaving a global network serving the pharma and biotech industry allows us to offer flexibility to our customers depending on their specific needs (supply chain optimization, regulatory requirements, cost-effectiveness) while assuring all activities are conducted to global quality standards.‚ÄĚ