WuXi AppTec Co., Ltd.

None\n Drug discovery is entering a new phase of complexity. From peptides and oligonucleotides to targeted protein degraders and other emerging modalities, many of today’s therapies require advanced chemistry, specialized manufacturing technologies and coordinated execution to move from concept to clinic.To help innovators address these challenges, WuXi AppTec has built an integrated CRDMO platform that connects discovery, development and manufacturing capabilities across multiple regions. By bringing these functions together within a unified system, the platform enables drug developers to advance programs more efficiently, reduce operational handoffs and move promising therapies toward patients faster.Recently, Fierce Biotech spoke with Yu Lu, Senior Vice President, Head of WuXi TIDES and WuXi Chemistry Business Operations at WuXi AppTec, about how integrated capabilities, cross-site collaboration and what many clients call “WuXi Speed” are helping advance the next generation of medicines.Fierce Biotech: As new drug modalities emerge, development and manufacturing partnerships are also evolving. From your perspective, what shifts are you seeing in how pharmaceutical companies approach development and manufacturing collaborations today?Yu Lu: One of the most significant changes is how pharmaceutical companies view their development and manufacturing partners. What was once treated simply as transactional, outsourcing has increasingly become a strategic collaboration, driven by three key needs: innovation, global quality, and speed.First, molecules are becoming more complex. As drug discovery expands into modalities such as targeted protein degradation, peptides, oligonucleotides, and complex conjugates, programs require specialized chemistry, new manufacturing technologies, and expertise across multiple stages of development. In this context, partners are expected not only to execute, but also to contribute scientific insight and problem-solving capabilities. Second, more companies are planning for global drug development and launch. This requires partners who can operate under consistent global quality systems and meet regulatory expectations across regions, ensuring a smooth path from development to commercial supply.Third, speed has become critical. Clients are looking for ways to move programs forward more efficiently, without compromising quality, because behind every program are patients waiting for new treatment options.Let me share a recent example. A client developing a complex divalent-siRNA-GalNAc conjugate approached us with the need for a complete CMC package to support an IND filing within just 8 months.  The complexity of the conjugate led to low yield and purity in single-strand synthesis and purification. Additionally, the impurity profile of the duplex was complicated and unstable, posing significant challenges for analytical method development.Our approach was to work closely with the client, addressing these challenges collaboratively while leveraging our expertise. Our team, drawing on extensive project experience, quickly identified suitable solid support and synthesis strategies. This increased the purity of the crude sense strand by more than 85% and enhanced the final yield by over 90%. The team also developed a robust analytical method to ensure that key impurities could be separated from the main peak. Simultaneously, multiple in-house teams coordinated development activities from API to drug product, ensuring alignment and progress. As a result, we delivered the necessary materials for the IND filing on schedule, enabling the client to meet their milestones. This is where an integrated platform can make a real difference. By connecting chemistry development, manufacturing, and supply within a unified system, teams can operate in parallel, anticipate challenges, and maintain consistent quality across regions. The result is faster, more reliable progression from discovery to patient access—without compromising the standards required for global development.Fierce Biotech: To meet the requirement of these new modalities, the underlying chemistry and manufacturing technologies also need to evolve. What are some of the key capabilities WuXi AppTec has been building to support this?Yu Lu: Over the past several years, we have focused on developing enabling technologies that help address the technical challenges associated with newer drug modalities.One important area is flow chemistry, which, as you know, enables continuous manufacturing processes that improve reaction control, safety and scalability, particularly for complex or hazardous reactions. Another key capability is biocatalysis. By applying novel enzymes and ultra-high throughput screening technologies, we can streamline synthetic routes for challenging molecules, including small molecules, peptides and oligonucleotides. Our capabilities in peptides and oligonucleotides also continue to advance alongside the growing complexity of these modalities. For peptides, we have developed integrated process approaches such as combining solid-phase and liquid-phase synthesis (SPPS–LPPS hybrid), enabling greater efficiency and scalability for longer and more complex sequences. Downstream, we apply advanced purification and API isolation technologies such as tangential flow filtration, continuous flow chromatography and spray drying to help improve yield, process robustness, and scalability. In oligonucleotides, we bring a similarly flexible and integrated approach. Innovations such as thin film evaporation (TFE), continuous flow chromatography help streamline downstream handling and reduce processing steps, while biocatalytic fragment ligation expands the toolkit for constructing more complex sequences. These advances are complemented by growing drug product capabilities designed to address delivery challenges. For peptides, we support both oral and parenteral drug product development and manufacturing from preclinical through commercial stages. So far, our team has supported over 70 preclinical and more than 10 clinical phase oral peptide projects. For oligonucleotides, delivery technologies such as lipid nanoparticles (LNPs) play a critical role in improving therapeutic performance. In addition, we recently expanded spray drying capacity across multiple sites in China and Switzerland, helping address bioavailability challenges for increasingly complex molecules.Together, these capabilities enable us to support new modality programs from early development through manufacturing, helping clients navigate increasing complexity while advancing their programs more efficiently toward patients. Fierce Biotech: How does WuXi AppTec’s global site footprint support clients as programs move toward manufacturing and commercialization? Could you share a specific example?Yu Lu: Infrastructure is essential for translating new technologies into scalable solutions. Our goal is to help clients move smoothly from development into manufacturing while maintaining flexibility and operational resilience.In Couvet, for example, we provide oral solid dosage manufacturing as well as packaging and labeling capabilities, allowing clients to supply finished drug products to global markets. In recent years we have expanded both manufacturing and packaging capacity there to support larger programs and increasing commercial demand. Today, the facility supplies multiple commercial drug products to Switzerland, the United States, European Union (EU), the United Kingdom, Japan, Australia, Canada, New Zealand, and China. A new PSD-4 spray dryer is expected to become operational in Q4 this year.  In the U. S., our Middletown, Del., campus, is expected to become operational in Q4 of this year. At that time, it will provide oral solid dosage manufacturing capabilities. The site will also offer packaging, labeling, distribution services and analytical development with quality control testing. Sterile fill-finish manufacturing will be available in 2027, and include vials, cartridges and prefilled syringes. These capabilities will support new modalities such as oligonucleotide and peptide drug products. Our San Diego site acts as another critical hub, enabling a seamless, integrated transition from API to drug product manufacturing for clinical supply.Meanwhile, we continue to expand API manufacturing capabilities at our sites in Asia. There are 12 manufacturing plants currently operational at our Taixing site. Two new small molecule API plants are expected to become operational this year, and two additional plants dedicated to oligonucleotide, peptide and PMO production are currently under construction and scheduled to be operational in 2027.Our Singapore site, currently under construction and also will be operational in 2027, will further enhance our global API manufacturing network for both small molecule and TIDES drugs.Our Wuxi City site has continued to expand its sterile injectable formulation and manufacturing capabilities in recent years. Now featuring five injectable lines, including one dedicated to high potency drugs, the site\'s total annual capacity exceeds 100 million units. These lines support various dosage forms, including liquid and lyophilized vials, pre-filled syringes, and cartridges.Together, these locations operate as part of a single integrated platform. Instead of coordinating work across multiple vendors, clients can rely on a unified global network with one global quality system that supports their programs from development through commercialization. Through continuous optimization of our global operations and integrated platform, we are able to accommodate increasing demand while maintaining high efficiency and reliability.One example that comes to mind involved WuXi AppTec’s successful mobilization of our Couvet site to manufacture a drug in Phase 3 clinical trials that the client had handled at its own site before ramping up production. Multiple teams collaborated closely, completing the manufacturing process transition and scale-up within five months. Detailed planning covered equipment compatibility assessments, analytical method validation, and procurement of raw and packaging materials — all completed well ahead of schedule. Through coordinated planning and parallel execution, this project was flawlessly completed through efficient work that enabled the client to submit the NDA (New Drug Application) on time. The drug was subsequently approved for market launch.Fierce Biotech: With such a broad manufacturing footprint, how do you ensure consistent quality and regulatory compliance across regions?Yu Lu: Quality is fundamental to everything we do. As our operations have expanded internationally, maintaining consistent quality standards across regions remains a top priority.To support this, we implemented “One Global Quality System,” which aligns quality standards, procedures and training across all sites. Instead of each location operating under separate local processes, teams follow a shared framework of GMP practices and standardized procedures. This assures that work performed in different regions meets the same expectations for quality and regulatory compliance.An important part of this system is the use of global digital platforms to manage documentation and quality data. Moving away from paper-based processes allows information to be shared and interpreted consistently across sites, helping teams operate with a common understanding of quality requirements.This framework has also been validated through regulatory inspections. In 2025 alone, WuXi AppTec underwent 741 quality audits conducted by global clients, regulatory authorities, and independent third parties, with zero critical findings. Fierce Biotech: Looking ahead, what areas of innovation are you most excited about?Yu Lu: The next few years will be very exciting for therapeutic innovation. We are seeing rapid progress in several areas that are reshaping how medicines are developed.Peptide-based medicines are transforming treatment approaches in metabolic diseases, while increasingly sophisticated peptide conjugates and other targeted delivery technologies are expanding the possibilities for precision medicine. At the same time, oligonucleotide therapeutics are moving beyond rare diseases into broader areas including cardiovascular and neurological conditions.These advances create new opportunities, but they also require new chemistry and drug delivery technologies, manufacturing approaches and supply chain solutions.Our focus is to continue strengthening our integrated platform so that clients can develop and manufacture these next-generation medicines more efficiently. By combining global infrastructure, new technologies and close collaboration with our partners, we aim to deliver speed, quality and value while helping innovative therapies reach patients around the world.

SAN DIEGO , CA, UNITED STATES, April 17, 2026 / EINPresswire.com / -- In today’s life sciences landscape, the journey from discovery to patient access remains long, complex, and resource-intensive. WuXi AppTec , a global CRDMO (Contract Research, Development, and Manufacturing Organization) provider, addresses these challenges by delivering integrated research, development, and manufacturing services through a unified platform to customers ranging from small biotechnology startups to global pharma corporations. The end-to-end drug development solution lowers barriers to innovation across the pharmaceutical and biotechnology industry and accelerates the delivery of new medicines to patients worldwide. What Is the CRDMO Model? WuXi AppTec’s CRDMO model is an integrated drug development model that combines research, development, and manufacturing into a single end-to-end platform. Unlike fragmented service models, CRDMO supports the full lifecycle of a drug, from early discovery through preclinical development, clinical testing, and commercial manufacturing, within one continuous system. This end-to-end drug development platform minimizes the need for transitions between multiple vendors, thereby reducing inefficiencies and improving consistency across stages. At its core, the integrated R&D and manufacturing platform enables seamless collaboration across scientific disciplines and operational functions. It allows drug developers to advance molecules more efficiently toward key milestones such as IND submission. This model is particularly valuable in addressing the increasing complexity of modern therapeutics, including small molecules, peptides, and oligonucleotides, where coordination across modalities and stages is critical to success. How Does CRDMO Differ from CRO, CDMO, and CMO Models? Unlike traditional CRO, CDMO, and CMO models that operate independently, WuXi AppTec’s CRDMO model integrates all stages into a single continuous platform. Traditional CRO, CDMO, and CMO each focus on a specific segment of the drug development process. This separation often introduces handoffs between stages, which can lead to delays, increased costs, and risks related to knowledge transfer or process inconsistencies. In contrast, WuXi AppTec’s CRDMO model integrates these functions into a unified platform, enabling continuous progression from discovery to manufacturing without disruption. WuXi AppTec’s approach is built on strong synergy across its core platforms, including WuXi Chemistry, WuXi Biology, and WuXi Testing, working in a coordinated, relay-like manner. This integration not only ensures seamless project transitions but also allows early insights from research to inform downstream development and CMC (Chemistry, Manufacturing, and Controls) planning. As a result, the CRDMO model enhances quality, reduces risk, and enables proactive capacity and technology alignment to meet evolving industry needs. What Are the Benefits of WuXi AppTec’s CRDMO Model for Biotech and Pharma? For biotech and pharmaceutical sponsors, WuXi AppTec’s CRDMO model directly addresses challenges such as long development timelines, high costs, and low R&D success rates. It simplifies the operating model and concentrates responsibility for execution with a single integrated partner. By eliminating fragmentation across vendors, the CRDMO model enables: • Faster progression from discovery to clinical and commercial stages • Reduced operational complexity and fewer vendor handoffs • Better alignment of development and manufacturing strategies from day one • Improved visibility into timelines, risks, and resource needs • The ability to focus internal teams on strategy and innovation instead of vendor orchestration WuXi AppTec’s CRDMO model is particularly relevant for biotech startups, academic spin-offs, and pharmaceutical companies seeking to accelerate drug development while reducing operational complexity. Startups and academic spin-offs often face limited resources and infrastructure. The CRDMO model enables them to access integrated expertise, advanced technologies, and GMP-scale manufacturing without building these capabilities internally. At the same time, large pharmaceutical companies benefit from improved efficiency, cost optimization, and faster pipeline advancement. Ultimately, WuXi AppTec’s CRDMO model translates into tangible outcomes: faster patient access, improved affordability, and increased likelihood of success in drug development. Summary The CRDMO model is an integrated R&D and manufacturing platform that combines research, development, and manufacturing into one continuous drug development system, replacing fragmented vendor relationships with a single, end-to-end partner. WuXi AppTec’s CRDMO implementation shows how this approach can reduce risk, shorten timelines, and expand access to new therapies for patients around the world. Key takeaways of CRDMO: • CRDMO = Integrated R + D + M: A unified model covering the full drug development lifecycle • Eliminates fragmentation: Reduces handoffs, delays, and operational risks • Enhances efficiency and quality: Seamless transitions across discovery, development, and manufacturing • Supports all innovators: From early-stage biotech to global pharmaceutical companies • Drives patient impact: Accelerates timelines, lowers costs, and improves access to new therapies WuXi AppTec WuXi AppTec +1 609-609-6504 wuxiconcierge@wuxiapptec.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Acurx Pharmaceuticals (NASDAQ: ACXP), a Staten Island, New York-based biopharmaceutical company developing small molecule antibiotics for difficult-to-treat bacterial infections, has closed a registered direct offering raising up to USD 7.1 million in potential gross proceeds, comprising USD 2.5 million upfront with up to an additional USD 4.6 million contingent on the exercise of short-term warrants. The offering involved the issuance of 825,085 shares of common stock at USD 3.03 per share, priced at-the-market under Nasdaq rules. A concurrent private placement issued short-term warrants to purchase up to 1,650,170 shares at an exercise price of USD 2.78 per share; the warrants are immediately exercisable and expire 24 months following the effective date of the registration statement covering the underlying shares. Acurx’s pipeline is built around its Gram-Positive Selective Spectrum (GPSS) platform, which targets bacterial DNA polymerase IIIC (pol IIIC), the primary replicative DNA polymerase in low G+C content Gram-positive bacteria. Because pol IIIC is absent in humans and Gram-negative bacteria, the approach is designed to selectively kill Gram-positive pathogens while leaving Gram-negative gut flora intact — a property the company has argued may reduce recurrence risk in infections such as Clostridioides difficile infection (CDI). The mechanism represents a class with no cross-resistance to existing approved antibiotic classes, including fluoroquinolones, beta-lactams, and glycopeptides. The lead candidate, ibezapolstat, targets CDI and is described by the company as Phase III-ready for international trials, subject to financing. Acurx recently launched an open-label pilot trial in patients with multiply-recurrent CDI who have experienced at least three episodes within the prior 12 months, enrolling 20 patients. Results from this study are intended to inform the design of a subsequent active-controlled Phase III registration trial in the recurrent CDI indication. Upon completion of Phase III, Acurx said it plans to seek US FDA approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs. The company has also received positive scientific advice from the European Medicines Agency confirming that its existing data package supports advancement of a Phase III program in Europe. Earlier preclinical pipeline work includes an oral candidate for acute bacterial skin and skin structure infections (ABSSSI) and a parallel program targeting inhaled anthrax. The GPSS platform has been advanced in part through a public-private partnership with Leiden University Medical Center, co-funded by Health~Holland under the Netherlands TKI Life Sciences & Health programme. That collaboration produced cryo-EM structural data on pol IIIC in complex with ibezapolstat and related inhibitors, published in Nature Communications in 2025, and a second Health~Holland grant was subsequently awarded to extend the work toward next-generation compound design. Acurx also holds a computational chemistry collaboration with WuXi AppTec to identify new inhibitor scaffolds beyond the current chemical series. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website