Q&A: Lonza's Christian Dowdeswell talks HPAPIs and the Oasmia deal
The mRNA boom has been beneficial for CDMOs, and Lonza is no different. It’s upgraded three of its sites — two in Europe and one in New Hampshire — since landing deals with Moderna to produce the biotech’s Covid-19 vaccine, and is being considered one of the bigwigs that will be responsible for more than half of the world’s drug capacity by 2025.
And last week, the Swiss drugmaker inched closer to that goal, when it announced the completion of a massive upgrade at a Nansha, China manufacturing site. The upgrade will expand the company’s ability to manufacture highly potent active pharmaceutical ingredients, and a deal has already been signed with Oasmia Pharmaceuticals to make its ovarian cancer drug candidate. That will start later this month.
Christian Dowdeswell, Lonza’s VP of commercial development for small molecules, talked to me about the intricacies of HPAPIs and the importance of having a presence in China. Here’s our conversation.
What are some of the things that make the development and manufacturing of HPAPIs complicated?
Due to its high toxicity, highly potent APIs are harmful, which means that manufacturing them requires an extremely strict containment and handling procedure to ensure the safety of engineers and an efficient technology transfer. This requires sophisticated facility designs, a protective strategy, as well as a well-trained workforce — which may be difficult to establish in-house. This is especially true for emerging companies who are more focused on improving the science of their compounds rather than manufacturing it.
What are some of the benefits that comes with having this site located in China?
For over 20 years, Lonza has had a presence in China and over time we have expanded our services to meet the needs of our customer portfolio of EMEA and US-headquartered customers. Our recently expanded HPAPI capabilities in Nansha allow us to continue leveraging world-class, high-quality and reliable local suppliers of raw materials to help for speedy problem-solving and manufacturing for our global network. The biopharma ecosystem in China is rapidly developing and our site helps us stay on the pulse on the market to support our global customers.
Can you tell me if other deals with companies have been signed? Are more on the way?
As of today, we have signed a partnership with Swedish company Oasmia Pharmaceutical AB to deliver cGMP-standard drug substance for their ovarian cancer drug candidate Cantrixil. We look forward to supporting our US- and Europe- headquartered partners at our Nansha site to support the success of their HPAPIs.
Is there anything else important about this deal that readers should know?
Lonza is an established partner in developing and manufacturing HPAPI, with more than 20 years’ experience in safely progressing more than 30 products from early-stage work to late-stage clinical or commercialization. The company has the capabilities in place to safely handle HPAPI to exposure levels up to 100ng/m3 across all manufacturing scales. With recent acquisitions, Lonza has also added particle engineering — micronization and spray drying — for improving bioavailability and final drug product formulation under full containment. The investment in China therefore complements Lonza’s range of HPAPI capabilities from development to commercial scale manufacturing, including formulation and delivery, with our investments in both technology and scale to ensure that we enable our customers to bring new medicines to patients faster.