Lonza to provide manufacturing for ValenzaBio from China facility

By Ben Hargreaves

- Last updated on GMT

Lonza Biologics Guangzhou facility © Lonza
Lonza Biologics Guangzhou facility © Lonza

Related tags: fill/finish, Lonza, Drug substances, China, bioreactor

Lonza will provide drug substance and product manufacturing for the biotech’s anti-IGF-1R antibody.

Lonza and ValenzaBio announced a manufacturing agreement that will enable the latter company to enter first-in-human clinical studies with its treatment candidate.

The potential therapy is an anti-insulin-like growth factor 1 receptor (anti-IGF-1R) antibody, known as VB421, which is being evaluated for the treatment of thyroid eye disease, as well as other inflammatory disorders.

Lonza will provide the manufacture of drug substance as part of the project from its location in Guangzhou, China. From there, the drug substance will be shipped to Switzerland for drug product fill and finish.

The Guangzhou facility is new to Lonza’s global network, after an announcement was made at the end of 2018​ that saw the company collaborate with the Guangzhou Development District and GE Healthcare to establish a presence in the area.

Jeetendra Vaghjiani, senior director of clinical development and strategic marketing at Lonza, told BioPharma-Reporter that the location was established specifically to support small-scale current good manufacturing practice (cGMP) manufacturing for clinical and early-commercial supply. The facility is outfitted with single-use bioreactors of 200L, 1,000L and 2,000L scale.

Vaghjiani explained that Lonza had leveraged its global manufacturing supply, involving its locations in China and Switzerland, to meet the accelerated timelines required to bring VB421 to clinical trials.

ValenzaBio’s potential therapy is currently in an investigational new drug (IND)-enabling program to support the first-in-human studies. The biotech has a pipeline of two drug candidates, an anti-CD19 treatment for membranous nephropathy, VB119, and VB421.

Supporting the biotech pipeline

In the announcement, Tatyana Touzova, chief operating officer of ValenzaBio, noted that partnering with Lonza allowed the biotech to progress its clinical candidate, despite ‘difficult times for global supply chains’. Touzova also added that securing reliable biomanufacturing is a challenge for smaller biopharma companies.

Vaghjiani confirmed that approximately 50% of its customer base is now represented by emerging, small biotech companies and virtual companies, with its contract manufacturing and development service observing a similar trend.

“An increasing number of these small companies will want to take their molecule to market but will lack the in-house expertise to do so, and therefore need to consider outsourcing​,” Vaghjiani stated.

Further than this, they noted that 73% of the global development pipeline is held by companies on the small and emerging end of the scale.

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