WuXi STA recently opened the doors on a high-potency active pharmaceutical ingredient (HPAPI) plant, located at its complex in Changzhou, China. To learn more about the plant’s R&D and manufacturing capabilities, as well as the market demands that helped fuel the expansion, Outsourcing-Pharma connected with Youchu Wang, senior vice president and head of STA early phase development with WuXi STA.
OSP: Could you please share your perspective on how the HPAPI market has shifted and evolved in recent years?
YW: I see an increasing demand for HPAPI from our customers in recent years. In 2021 alone, we completed more than 50 projects of high potent API (HPAPI). This trend, on one hand, is the result of the proliferating emergence of anti-cancer therapy and antibody-drug conjugates. These molecules are often highly target-specific and are generally highly potent or even cytotoxic, and on the other hand, the improving consideration for manufacturing safety has pushed innovators to classify novel molecules with unknown potency to HPAPI until further evaluation.
With this unprecedented popularity, you can already foresee a huge manufacturing capacity gap. And do keep in mind that complex conjugates, including oligonucleotide and peptide-based conjugates and ADCs, as well as other HPAPIs, are especially challenging to manufacture. HPAPI manufacturing requires special containment equipment to meet an operational exposure limit (OEL) to be as low as 10µg/m³ for operation safety. So most of the innovators developing these targets need to outsource HPAPI development and manufacturing due to their limited in-house capabilities that otherwise require an outstanding amount of facility investment.
That’s why we now are seeing such high demand. The compounding factor is then whether the CDMO you work with has sufficient technical acumen as well as containment facilities at scale to take you from target to commercial treatment.
OSP: Why did you select the Changzhou site to open the new HPAPI plant?
YW: With a 74-acre campus, our Changzhou site is an integrated API process R&D and manufacturing site with more than 2,800 highly skilled scientists, providing the required infrastructure for the expansion. The services of the Changzhou site cover small molecules, oligonucleotides, and peptides, so the opening of this new plant not only directly enhances our HPAPI manufacturing capacity but also strengthens our new modality CRDMO platform by manufacturing highly potent payloads to support oligo and peptide-based complex conjugate production.
Now with the new plant in operation, our HPAPI platform has multiple R&D labs, GMP Kilo labs, and two plants across the Changzhou site and Shanghai Jinshan site, offering dual supply options for customers within the same company.
Another unique value of this HPAPI plant in Changzhou is the fact that our drug product manufacturing site in Wuxi city is only one hour away by driving. Our HP drug product manufacturing plant is about to open soon this year. Once opened, we can provide integrated HP CMC solutions including both API and drug product by teams from close locations for fast, flexible, and streamlined services.
OSP: Can you tell us a bit about the capabilities and equipment that will be in play at the new plant?
YW: The key strength of the new plant is the scale. With reactors from 250 L to 3,000L, a wide range of prep-HPLCs, and a 10 m2 tray lyophilizer, our new plant is a crucial part of our HPAPI platform to support our customers at any scale from preclinical to commercial. And in a flexibility aspect, the new plant also features a selection of enabling technologies including flow chemistry and milling capabilities.
OSP: Do you have any plans to grow or expand in the future?
YW: Specific to HPAPI capability and capacity, our expansion won’t stop at this new plant in Changzhou. We announced our new 170-acre Taixing site in Jiangsu China last year. We will build more HPAPI plants in Taixing in the next few years.
Besides HPAPI, we are continuously expanding across small molecules and new modalities including oligonucleotides, peptides, and their conjugates around the globe. All our facilities in the world follow one quality system, inspected by all major regulatory agencies. So, we are confident our products meet the high-quality standards at all times with the fast-increasing capacity.