Pharmaceutical manufacturing company Lonza has announced the completion of the laboratory expansion at its active pharmaceutical ingredients (API) manufacturing site at Nansha, China. The expansion reportedly is centered on extending the capabilities and capacity of development laboratories and kilogram-scale cGMP manufacturing laboratories for clinical supply of highly-potent APIs (HPAPIs).
To learn more about the growth in demand for APIs and HPAPIs and the expansion of the site, Outsourcing-Pharma connected with Jan Vertommen, executive director and head of commercial development for small molecules (EMEA and APAC) with Lonza.
OSP: Could you please talk about Lonza’s growth in recent years, especially in the area of API and HPAPI manufacturing?
JV: With more than 20 years of experience, Lonza has been a strategic partner in developing and manufacturing HPAPIs by safely progressing more than 30 products from early-stage work to late-stage clinical or commercialization. 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 recent investment in China, therefore, complements Lonza's range of HPAPI capabilities in the network ranging from early development to commercial-scale manufacturing, including formulation and delivery, to enable customers to bring new medicines to patients faster.
OSP: What are some of the key challenges in API/HPAPI manufacturing? Please feel free to talk about challenges related to the market as well as manufacturing (i.e. technology, safety, etc)
JV: Commercially, the timeline for developing and manufacturing HPAPIs is increasingly being shortened due to quicker approvals and improved compounds due to continued R&D and innovation. This trend presents significant manufacturing challenges, especially for smaller biotech and startups that bring many of these HPAPIs to the table.
As these emerging companies are focused on the science behind their molecules, they often do not have in-house resources to rapidly produce their HPAPIs. In that case, an external manufacturing partner is the strategic choice as they can provide their expertise, engage in technology transfer activities, and exchange information, ideas, and best practices across the drug development cycle.
In terms of manufacturing, the first challenge with working with HPAPIs is establishing a good understanding of the toxicological aspects of the compounds as it dictates the level of critical measures we need to implement. At Lonza, we have the capabilities in place to safely handle HPAPI to exposure levels up to 100ng/m3 across all manufacturing scales. Once that’s determined, the following challenges are ensuring that processes are in place to limit potential exposure down to the required level and defining a robust cross-contamination prevention program to ensure patient and personnel safety.
As HPAPIs are highly toxic, it is imperative to apply only proven strategies for primary and secondary containment and risk assessments; establish appropriately designed assets and processes; provide robust training for personnel to keep our lab and plant personnel safe, and ensure that the products handled are safe for the patient. Finally, to enable a smooth technology transfer, it is necessary to have a thorough process understanding and a capable analytical methodology to identify appropriately low amounts of HPAPIs.
OSP: Please tell us about the background of the Nansha site—how long has Lonza been operating it, and why was this particular facility a good candidate for expansion?
JV: Lonza started its CDMO activities in China more than 20 years ago as one of the pioneers in providing CDMO services to global customers out of China. The site in Nansha gradually expanded, serving a customer portfolio of EMEA- and US-headquartered customers. The portfolio contains commercial products as well as products in early and late phase development for sale around the globe.
The key advantage of our presence in Nansha is that it allows us to leverage world-class, high-quality, and reliable local suppliers of raw materials to help further increase the speed of problem-solving and manufacturing within our global network. The Nansha site also allows us to have a close pulse on the regulations in China which helps us support our global customers produce commercial products for the Chinese market or support the production of clinical materials for trials in China.
OSP: Then, please share some detail about the expansion—i.e. the scale of the expansion, anticipated additional equipment/technology, etc.
JV: Our recent expansion focused on extending the capabilities and capacity of development laboratories and kilogram-scale cGMP manufacturing laboratories for the clinical supply of HPAPIs. The laboratory capabilities will increase the laboratory footprint to 250m2 and will be equipped with state-of-the-art analytical and manufacturing equipment.
These new labs are part of our recent investment to expand the mid-scale manufacturing capacity of our Nansha site. It will add additional capabilities to Lonza’s global HPAPI manufacturing network to meet growing customer demand. The mid-scale expansion will include six 1,000L small molecule reactors, four 1500L vessels, and isolation equipment providing mid-scale capacity to bridge between early-phase and late-phase production.
OSP: I understand Lonza already has secured a manufacturing partnership with Swedish pharma company Vivesto (formerly Oasmia) tied to the expanded site. Could you please tell us a bit about your relationship with Vivesto, and why partnering with Lonza via the expanded site might benefit/appeal to them?
JV: Lonza is excited to partner with Vivesto to help advance its promising drug candidate to the clinic. Lonza has extensive experience in supporting the development and manufacturing of challenging molecules and will provide kilogram-scale synthesis, purification, and stability testing of Cantrixil, and deliver cGMP batches of drug substances for clinical supply.
The know-how of the site, the proximity of raw material suppliers, and equipment fit made it an obvious choice for Vivesto as one of the many European- and US-headquartered customers that have selected the site for development and manufacturing for their clinical and commercial needs.
OSP: Is there anything you would like to add?
JV: The Nansha site is an integral component of our global drug substance and drug product design, development, and manufacturing network. The expansion of our Nansha, China site demonstrates our commitment to ensuring integrated manufacturing services from early- and late-stage development to commercial manufacturing serve our global partners, especially small and emerging companies. This commitment is grounded in data that shows outsourcing to a single partner can significantly decrease costs and shorten timelines – meaning that if we can provide our partners with services from proof of concept to commercialization, then we can help them meet market demands in a more cost- and time-efficient nature.