WuXi STA, a subsidiary of WuXi AppTec, is a pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations. As a contract development and manufacturing organization (CDMO), WuXi STA offers worldwide partners efficient, flexible and high-quality solutions for integrated CMC (chemical, manufacturing and control) from preclinical to commercial. In this article, co-CEO of WuXi AppTec and CEO of WuXi STA, Minzhang Chen, shares insight into the company’s recent growth through capacity expansions and new technology investments.

Contract Pharma: How would you describe the current state of the pharmaceutical contract services industry?
Minzhang Chen: Contract services have been booming in the pharmaceutical industry for the last decade, especially with a big surge caused by the pandemic in the past two years. The challenge for CDMOs has been how to adapt to this growing demand and look ahead of needs, adding new capacity globally, with the best available development and manufacturing technologies.

CP: What impact did Covid have on WuXi STA’s business?
MC: Amid all the difficulties posed by the pandemic, WuXi STA continued to grow fast in terms of customers and projects, and we have set our sights on increasing our global site presence. To give just a smattering of highlights, we currently are working on 1,113 molecules in preclinical and phase I, 220 molecules in phase II, 48 molecules in phase III and 32 commercial projects. However, we are not alone in having had a successful year, and we are now seeing record levels of investment, more therapies coming through and rapidly increasing prevalence of contract services.

CP: Where is WuXi STA investing for future growth?
MC: WuXi STA must look ahead of our client demand and invest in the next generation of technologies and capacities needed if we are to meet rising customer needs. Recently, we have announced expansions for our small molecule API and drug product capability and capacity, large levels of investment into new modality platforms like oligonucleotide and peptide, acquisition of our first facility in Europe and commitment to building a new site in the U.S.

Looking deeper at the growth areas we have seen, our small molecule API business, supported by a team of more than 2,500 scientists continued to grow quickly over the last year. In response, we are significantly increasing our API capacity with 15 new plants and 2,486 cubic meters more total reactor volume in the next two years.

Our integrated API process development and manufacturing site in Changzhou, China currently has nine plants with 960 cubic meters total reactor volume. In our phase III expansion plan, we are adding another six plants reaching more than 2,000 cubic meters total reactor volume, and an additional R&D center by 2023, and the site will become a 74-acre campus with two R&D centers and more than 1300 scientists, 15 plants and more than 400 reactors.

I am also excited to mention, to meet fast-growing customer needs, we committed to building a new API site in Taixing, China. The location is less than one hour from our Changzhou site maintaining the geographic integration that our clients value. The 170-acre new facility will house another fully integrated R&D and manufacturing site for API process development and manufacturing, in addition to Changzhou and Jinshan sites. The site will have capabilities across all small molecules, oligonucleotide and peptide platforms, with advanced technologies to enable complex chemistry such as high potency and a variety of conjugates. The site phase build out plan includes eight small molecule plants and one oligo and one peptide plant to start operation by 2023.

Yet, perhaps our most high profile of recent developments was the purchase of a state-of-the-art facility from BMS in Couvet, Switzerland, completed in July 2021. This has further strengthened our overall drug product capabilities, but also, presents our clients with greater options in Europe and global markets. This facility is only three years old and is currently manufacturing Revlimid for seven markets, including Switzerland, the U.S., Europe, Japan, Australia, Canada, and New Zealand. We plan to add extra oral solid dosage production and analytical capabilities and capacities at the site soon.

CP: What about new technology investments? Where is WuXi STA eyeing growth?
MC: Capacity alone is only as good as its use case, and that is why we have continued to enhance our capabilities in new technologies. With increased interest from our partners in sustainable processes, we are expanding our continuous manufacturing (flow chemistry) technology platform by adding 18 more production lines in addition to our current four lines. The rapid growth of our flow chemistry platform is a reflection of our commitment to develop greener and safer processes.

One of the largest shifts we have undertaken in the last two years is to sizably enhance our capabilities for new modalities like oligonucleotides and peptides. Responding to growing clients’ needs, we have built an experienced oligonucleotide team of 240 scientists and a peptide team of 224 scientists. 

In oligonucleotides, we have a comprehensive R&D and manufacturing platform for oligonucleotide customized monomers, linkers, conjugates, APIs and drug products, all under one roof. Our capability covers a broad range of oligonucleotides including ASO, siRNA, aptamer, microRNA, PMO/PPMO, etc. With the increasing demand for higher volume therapies, as the modality is moving beyond predominantly orphan drug indications, oligo API production capacity remains a global challenge. Consequently, we will build more capacity by adding additional lab-scale lines and two more large-scale plants—one in Changzhou and another in Taixing—in the next two years. 

Similarly, we have also built a vertically integrated peptide platform from unnatural amino acid production to peptide API and formulation, with one of the largest peptide API manufacturing facilities worldwide. The Changzhou site currently has 9 peptide production lines at various of scales, our expansion will add two large scale peptide plants, one in Changzhou and one in Taixing, in the next two years. 

In small molecule drug product business, we have been equally active. At the Wuxi City formulation development and manufacturing site, we just opened a new R&D center this May inside an 11,000 square meter building that will house over 500 formulation and analytical scientists, including oral, injectable and analytical platforms. Running alongside this, we will open a new building for GMP manufacturing including wet and dry granulation and coating for oral dosage forms by the first quarter of 2022, and a parenteral formulation line with vial, cartridge and pre-filled syringe capability by the fourth quarter of 2021. 

From both API and formulation perspectives, we have seen the continued rise of poorly soluble drugs, and to help address this we are continually increasing our use of enabling technologies notably, spray dried dispersion (SDD). Our SDD platform is seamlessly integrated into our API and drug product platforms. In 2020, we partnered with several late phase and commercial campaigns, including the launch of Innocare’s Orelabrutinib in China, and become the first CDMO in China with commercial success with SDD technology. Due to increased customer demand we plan to triple our capacity by adding more PSD-3 and PSD-4 large-scale spray dryers in the next two years.

CP: What else can we expect from WuXi STA in the near future?
MC: Looking further ahead, and announced just a few months earlier, we have committed to construct a new facility in Middletown, Delaware in the U.S., which is scheduled to open in 2024. The site, once opened, will be our largest U.S. facility, housing one-stop-shop manufacturing services covering both API and drug product. It’s a development we are particularly excited about because we will empower our clients with regional supply in three continents across Asia, North America and Europe, with much greater flexibility to respond to their changing needs. This 190-acre site will feature manufacturing for APIs, oral solid and injectable drug product, as well as packaging and labeling services. 

Yet, all these exciting site additions are not the end of the cycle, but part of a wider continuous development of our services. In parallel to our new site expansions, WuXi STA is now to become a part of WuXi Chemistry, a newly announced business unit of WuXi AppTec and a contract research, development and manufacturing organization (CRDMO)—giving customers a pathway from discovery all the way to commercial launch for any synthetic molecule and meeting any material requirement at any scale. As of June 30, 2021, WuXi Chemistry has 10,190 scientists for research business, 3,741 API process development chemists and formulation development scientists for development business, and 4,036 manufacturing staff for manufacturing business. 

What we have seen is that with innovation coming from wider sources and targets getting more complex, innovators need a partner that can expeditiously and seamlessly advance their drug candidates between stages. The choice of capabilities at contract partners is therefore a mission-critical component of meeting milestone targets, but it can also be the ultimate deciding factor in the potential developability of targets.