Lonza announced the start of new mid-scale manufacturing assets at its API manufacturing centre in Nansha, China. Jan Vertommen, executive director, global head of sales, Small Molecules, Lonza, discussed the current manufacturing landscape in China and how Lonza's new investment aims to meet the growing small molecule demand.
Key highlights:
- Lonza has expanded its mid-scale manufacturing capacity in China, with a new mid-scale manufacturing site.
- Part of a CHF 20 million investment in 2021, the site aims to support a smooth transition between early-phase and large-scale commercial production.
- As China is a good source for raw supply materials, the China market is favourable to increase clinical trials and the release of commercial products.
The new site is an addition to the current site's early-phase capacity to handle highly potent compounds, which opened earlier in the year, and the large-scale capacity of up to 10,000L that has already been operational for many years.
The expansion includes six 1,000L reactors, four 1,500L reactors, and isolation equipment providing mid-scale capacity to bridge between early-phase and late-phase production. The investments will allow Lonza to provide customers with a smoother transition from small to large-scale manufacturing while maintaining global quality and regulatory standards.
Vertommen commented: "The Nansha site is fully integrated within Lonza’s global Small Molecules manufacturing network. Scientists and engineers based in Nansha focus on API development and manufacturing for customers around the globe. The team also includes regulatory specialists with experience working with Chinese regulators throughout the drug development and scale-up process. The expansion has created approximately 70 new positions, increasing the total employee community to approximately 330 at the site."
With the API market expected continuous growth over the next several years, and consequently, the demand for commercial API manufacturing, Vertommen explained the Nansha site investment aims to meet this demand.
"Our expanded Nansha site will support our global partners’ transition between early-phase and large-scale commercial manufacture – from clinic all the way to the market – while maintaining global quality and regulatory standards."
Pharma manufacturing landscape in China
The Chinese biopharma market is the second largest in the world today and is encouraging of biotech growth.
Vertommen adds: "Though many of the country’s domestic pharmaceutical companies have historically focused on generics and biosimilars, many companies in China are now moving to address unmet medical needs by investing in innovative R&D approaches, new drug formats, complex modalities, and digitalisation.
As a result, Vertommen explained that western-headquartered pharmaceutical companies are pivoting to the Chinese market, by running more clinical trials and marketing more commercial products to the Chinese market.
"The increased activity from global pharma companies regarding both clinical and commercial pursuits, as well as the robust ecosystem, has resulted in an industry that is catching up with that of Western countries. In terms of pharma manufacturing, it is quickly developing due to the growing talent pool and access to resources. For international companies, having a manufacturing presence in the Chinese market, either directly or through a CDMO, is often part of a global manufacturing network strategy. In fact, our API manufacturing site in Nansha for clinical trials and commercial products largely services our western-headquartered customers as part of our global manufacturing network."
China is a strategic manufacturing hub
"We find there are a number of opportunities in China due to the accelerated growth of the pharma ecosystem. This is fuelled by government support, strong financial funding, increased capability, and a growing R&D and manufacturing talent pool."
Vertommen said that China is an excellent source of raw supply materials which makes it a "strategic manufacturing hub" for Lonza, supporting the international demand for small molecule drugs.
"Our recent expansion is now conducting mid-scale commercial manufacturing, and is prepared to leverage these opportunities. Our Nansha site is fully integrated within our global Small Molecules manufacturing network. Lonza’s scientists and engineers based in Nansha focus on API development and manufacturing for customers around the globe. The team also includes regulatory specialists with experience working with Chinese regulators throughout the drug development and scale-up process."
The trend of small molecules is growing due to the interest in developing treatments for rare diseases, personalised medicines, and challenging areas such as oncology.
"This is due to the advances in our understanding of diseases and disease mechanisms, which are enabling the identification of novel drug targets. These new molecules are often highly potent and may not be needed in large volumes, even for commercial products. In response, we have continually invested in highly potent API capabilities across our global network, and focused on expanding our mid-scale manufacturing capacity," Vertommen discussed.
Commercial mid-scale operations are now underway at the expanded manufacturing facility, which was part of a CHF 20 million investment announced in June 2021.