During DCATWeek, Axplora brought its bold thinking when serving customers to one of NYC’s most iconic views—Top of the Rock. In this exclusive video interview, Martin Meeson (CEO) and Arul Ramadurai (CCO) discuss how Axplora is pushing the limits of what’s possible in #APIManufacturing— and what it means to be a “technologically savvy manufacturing partner” for the world’s most ambitious biopharma innovators... Attending the DCAT Summit Lugano is a golden opportunity for professionals in the biopharmaceutical industry looking to expand their networks and gain invaluable insights. This event promises to be an experience to remember. Located in the stunning jewel of the Lugano area, it offers the perfect combination of learning, connecting, and enjoying the breathtaking surroundings. This is a fantastic opportunity... We recently had the opportunity to sit down with Alex del Priore, Senior VP at Syngene, for a fascinating conversation about their new site acquisition in Baltimore. It was great to hear Alex’s insights on what this means for Syngene, the impact on their operations, capabilities and customers demand. We really enjoyed discussing the values that drive such strategic decisions and how they align with Syngene’s commitment to... CIPLA
NEWS Axplora, a global leader in small molecule API manufacturing and a trusted partner to the world’s most innovative pharmaceutical companies, today announced that the total investments initiated across its global network in 2025 will exceed €100 million. This commitment underscores Axplora’s determination to accelerate growth, strengthen capabilities, and reinforce its position at the forefront of pharmaceutical manufacturing worldwide. The total includes the increased amount of €60 million allocated to the ongoing expansion of its Mourenx, France site, alongside €35 million at Gropello, Italy, and €8.5 million at Vizag, India, both announced earlier this year. In addition, March this year saw the expansion of Axplora’s ADC (antibody-drug conjugate) manufacturing capabilities at is site in Le Mans, France. Strengthening capacity, capability and delivery These projects extend across several years, embedding long-term capability across the business. The scale of the Mourenx initiative, in particular, is giving Axplora’s teams the opportunity to expand expertise and set new benchmarks of excellence through close collaboration with a customer on a project of significant size and complexity. Insights and best practices developed there are now being shared across Axplora’s nine global sites, strengthening a culture of continuous improvement and ensuring every site is equipped to deliver best-in-class execution with reliability, speed, and efficiency. While new modalities such as GLP1 peptides and ADCs stand out as high-growth opportunities, small molecules remain the foundation of global pharmaceutical manufacturing, accounting for the majority of prescriptions today and well into the future. Axplora’s €100m investment program reflects this balance: reinforcing large-scale small molecule capacity, while also expanding in highgrowth, high-complexity areas. By investing across modalities, Axplora is ensuring resilience and reliability for the essential medicines patients depend on today, and readiness for the advanced therapies that will define tomorrow. Martin Meeson, CEO of Axplora, commented: “Announcing €100 million of investment this year is a landmark for Axplora – but more than just a number, it represents the trust our customers place in us and the scale of our commitment to them and their patients. Each euro invested is directed towards strengthening our capabilities, expanding our global network, and ensuring we are prepared to deliver the next generation of medicines with speed and reliability.” Arul Ramadurai, CCO of Axplora, added: “These investments reflect the trust our customers place in us and our commitment to working side by side with them. At Axplora, we dare to imagine a future where no patient waits for the medicines they need. That vision drives us to understand our customers’ needs better than anyone else, and to build the scale, expertise, and capabilities that will help bring their breakthroughs to life faster and more efficiently.” Axplora initiates global investments exceeding €100m in 2025 1 DAILY NEWS CPHI 2025 FRANKFURT DAY 1 | 28th October 2025
2 NEWS DAILY NEWS CPHI 2025 FRANKFURT DAY 1 | 28th October 2025 Ensera launches as new brand identity for SteriPack SteriPack, a global contract design and manufacturing organization (CDMO) for the pharmaceutical and medical device industries, has announced its trading name change to Ensera, signaling a strategic shift in its identity and service offering. Ensera represents the company’s evolution into a global partner providing industry-leading expertise in medical device design and manufacturing, and final assembly and secondary packing for pharmaceuticals and drug-device combination products. Alongside this transformation, its design consultancies, HS Design and Kinneir Dufort, will now trade under a unified name: Ensera Design. “Changing our trading name to Ensera reflects our enhanced service offering, global reach and the broader, bolder role we play in today’s healthcare ecosystem,” said Jason Anderson, CEO of Ensera. “From tackling design-to-manufacture gaps to enabling faster, smarter delivery of combination products and medical devices, we’re building a business ready for the future and committed to helping our customers improve patient lives through better health outcomes.” For more than 30 years, SteriPack has supported the world’s leading pharmaceutical and medical device businesses with cleanroom manufacturing services. But with rising industry demands - including decentralized care, the rapid growth in biologics and biosimilars, greater supply chain resilience and increased focus on patientcentric design - the company recognized the need to evolve. Ensera connects new and next generation product design with cleanroom contract manufacturing, assembly and packing services, helping innovators move from idea to market-ready product and commercial ramp-up with greater speed and precision. Its services now include: - Design and product development - Design for manufacture - Device component manufacture - Manual to automated device assembly - Cleaning and rinsing of primary components - Sterile barrier system packing and kitting - Secondary packing of
3 NEWS DAILY NEWS CPHI 2025 FRANKFURT DAY 1 | 28th October 2025 pharmaceuticals and combination products - Labeling, serialization and aggregation - Sterilization management - Supply chain, cold chain and regulatory support “Our customers came to us with the same challenges time and time again – shorter, more agile and flexible supply chains, low-to-medium volume requirements often with a high SKU mix, and complex or customized device manufacturing and assembly needs to deliver innovative new standards of care to market,” said Anderson. “Now, with more integrated capabilities, we’re removing these barriers and helping pharma and medical device industry leaders reach the point of care providers faster.” Ensera Design is an international healthcare-focused design consultancy formed through the integration of US-based HS Design and UK-based Kinneir Dufort. Together, they bring decades of complementary, award-winning expertise in user experience, human factors, product development and designfor-manufacture, underpinned by a deep understanding of the quality standards and regulations governing healthcare product provision. Operating across both sides of the Atlantic, Ensera Design partners with established pharmaceutical, MedTech and consumer health companies and start-ups to deliver safe, high-performance, market-ready devices and digital solutions destined for commercial success - with the added benefit of integrated manufacturing capabilities through the wider Ensera Group. “Every product we collaborate on with our customers is ultimately about a person,” added Anderson. “That’s why we’ve built a design consultancy that combines deep user insight, technical rigor and manufacturing know-how to bring better healthcare solutions to life.” With available and expanding capacity across the United States, Europe and Southeast Asia, and ongoing investment in facilities, infrastructure and capabilities, Ensera is positioned to support the next generation of healthcare innovation. This transformation offers clients deeper collaboration, broader expertise and streamlined access to Ensera’s full suite of design and manufacturing capabilities. “We’re not just solving design and manufacturing challenges, we’re helping shape the future of healthcare,” said Anderson. “Our new names, Ensera and Ensera Design, reflect our commitment to fresh thinking, exceptional execution and long-term partnership.”
4 NEWS DAILY NEWS CPHI 2025 FRANKFURT DAY 1 | 28th October 2025 VERDOT, a French leader in downstream bioprocessing technologies, is pleased to announce a new strategic agency partnership with GMI, a trusted provider of laboratory solutions headquartered in Ramsey, Minnesota, USA. This agreement marks a significant step in VERDOT’s expansion into the United States, bringing its cutting-edge single-use systems to a broader range of biopharmaceutical manufacturers. GMI has served the life sciences industry since 1995, delivering high-quality laboratory equipment and services to academic institutions, research organizations, and industrial clients across the U.S. The company is recognized for its commitment to customer support, extensive service expertise, and dedication to helping laboratories achieve cost-effective performance. Through this partnership, GMI will act as an agent for VERDOT’s singleuse FlexiPro™ and conventional MiniPro™ systems, enabling U.S. clients to benefit from VERDOT’s unique expertise in GMP purification and downstream processing from pilot through commercial production scales. Together, the two companies will support biopharmaceutical and biotechnology firms with solutions designed to optimize workflows, accelerate development timelines, and increase access to advanced therapies. Charles Ruban, President and CEO of VERDOT, stated, “We are thrilled to announce our partnership with GMI. Their expertise in purification equipment, combined with their commitment to quality and customer service in the U.S., makes them the perfect partner for VERDOT. Through this collaboration, we will be able to propose our unique FlexiPro™ Chrom and TFF product lines, renowned for their flexibility and performance, to a broader audience of biotech, CDMO, and biopharma customers. We look forward to achieving great success together.” Justin Volling, President and CEO of GMI commented, “We are beyond excited to partner with VERDOT, a company that shares GMI’s commitment to exceptional customer experience, sustainability, and uncompromising quality. We’re confident that our team’s expertise, experience and base of loyal customers will help amplify VERDOT’s offering of tailored purification solutions in North America. This partnership is an immensely impactful addition as we continue to deliver unparalleled value to our customers.” This partnership will leverage VERDOT’s decades of expertise in downstream purification with GMI’s established U.S. network to provide customers with high-performance, cost-effective purification solutions that drive innovation in biopharmaceutical manufacturing. VERDOT and GMI announce new agency partnership to strengthen bioprocessing and advance biopharmaceutical manufacturing in the United States FDA approves Boehringer drug to treat idiopathic pulmonary fibrosis The U.S. FDA announced approval of Boehringer Ingelheim’s Jascayd (nerandomilast) tablets to treat idiopathic pulmonary fibrosis (IPF) on October 7th. According to the agency press release, this is the first new therapy approved in over 10 years for IPF. Per the release, approval of nerandomilast was based on two Phase III randomized, double-blind, placebo-controlled trials involving adults with IPF. The primary endpoint was the absolute change from baseline in Forced Vital Capacity (FVC), or the maximum amount of air a person can forcefully exhale after taking the deepest possible breath. The study found that individuals taking nerandomilast had a significantly smaller FVC decline compared to placebo-treated patients. IPF is a rare disease that affects the tissue surrounding the alveoli in the lungs. Over time, it can cause permanent lung scarring, making it more difficult to breathe. The disease has no known cure and limited treatment options. “Today’s approval furthers FDA’s longstanding commitment to support treatment options for patients and advances in health care for the American public,” said the agency in the release.
6 NEWS DAILY NEWS CPHI 2025 FRANKFURT DAY 1 | 28th October 2025 Bristol Myers Squibb announced a definitive agreement to acquire Orbital Therapeutics, a biotechnology company developing RNA medicines that reprogram the immune system in vivo, for $1.5 billion. This acquisition will grant BMS the rights to Orbital’s lead candidate OTX-201, an in vivo CAR-T treatment that targets autoimmune disease through B-cell depletion to reset the immune system. According to a company press release, OTX-201 is an RNA immunotherapy preclinical candidate currently in IND-enabling studies. The candidate consists of an optimized circular RNA encoding a CD19-targeted CAR for in vivo expression and delivered via targeted LNPs. In addition to OTX-201, BMS will acquire Orbital’s proprietary RNA platform, which is designed to deliver durable, programmable therapies via circular and linear RNA engineering, advanced LNP delivery, and AIdriven design. “In vivo CAR T represents a novel treatment approach that could redefine how we treat autoimmune diseases,” said Robert Plenge, MD, PhD, Executive VP, CRO, BMS, in the press release. “This acquisition enhances our robust cell therapy research platform and provides an opportunity to advance a potential best-in-class therapy designed to deplete autoreactive B cells and reset the immune system. We are excited by the promise this holds for patients with autoimmune diseases who are waiting for better options.” “This agreement with Bristol Myers Squibb, a recognized leader in global medicine, marks a transformational moment for Orbital and the advancement of RNA medicine,” said Ron Philip, CEO, Orbital Therapeutics, in the release. “Since inception, Orbital has made significant strides developing a differentiated RNA platform designed to enable a new generation of RNA medicines that reach more tissues, address more diseases, and benefit more patients. The promising early data from our lead program, OTX201, underscore the strength of this approach and the potential of our integrated RNA technologies. Together, we aim to deliver RNA medicines that provide patients with treatments that are simpler, safer, and more accessible compared to today’s complex therapies.” Bristol Myers Squibb inks $1.5 billion orbital therapeutics acquisition Thermo Fisher Scientific introduced the Molecular Microscope Diagnostic System for Lung (MMDx Lung) on October 8th, a new diagnostic tool designed to aid pathologists in determining lung transplant rejection and injury. According to a company press release, the MMDx Lung profiles gene expression data from lung biopsies and compares each sample to a reference set of over 896 lung biopsies. Following the assessment, the system provides molecular scores associated with injury, graft dysfunction, and rejection. MMDx Lung was developed and validated by Kashi Clinical Laboratories, a provider of clinical and molecular tests for various health conditions and disorders. According to the release, this laboratorydeveloped test is intended for clinical use by the CLIA-certified laboratory performing the test. This test has not been cleared or approved by the US FDA or CE marked in the EU as an in vitro diagnostic test. In the United States, MMDx Lung is delivered through a collaboration with Kashi. “The diagnosis of rejection and injury in lung transplants is very challenging,” said Phil Halloran, Director, Alberta Transplant Applied Genomics Center and CEO, Transcriptome Sciences, in the release. “Based on technology developed by the investigators in the INTERLUNG study, we believe MMDx Lung will better diagnose rejection and detect Chronic Lung Allograft Dysfunction (CLAD)-related molecular changes, and thus provide a better guide for treatment and potentially for clinical trials, as a step toward improving survival of lung transplants.” “Accelerating clinical decision-making through the delivery of high quality, rapid results, is central to our mission of advancing health and healing to every patient we serve,” said Dr. Todd Johnson, CEO, Kashi Clinical Laboratories, in the release. “We’re proud to expand our collaboration with Thermo Fisher Transplant Diagnostics to deliver services for lung, in addition to kidney and heart transplant testing.” Thermo Fisher Scientific introduces lung transplant diagnostic system
10DAILY NEWS CPHI 2025 FRANKFURT DAY 1 | 28th October 2025 NEWS Sunresin is proud to announce that Dr. Ivy Gao, CEO of Sunresin, has been nominated for the “Women of the Year” category at the 2025 CPhI Awards, one of the most prestigious recognition in the pharmaceutical and life sciences industries. The CPhI Awards Gala will take place on October 28, 2025, during the CPhI Worldwide exhibition in Frankfurt. These awards celebrate outstanding achievements in leadership, innovation, and contributions to the global pharmaceutical ecosystem. This nomination reflects Ms. Gao’s visionary leadership, entrepreneurial spirit, and pivotal role in building Sunresin from the ground up, transforming a bold idea into a thriving international company recognized for its resin technology innovations. Through her determination and strategic vision, Ms. Gao has led Sunresin’s evolution from a small startup to a global player with a strong presence in the life sciences and pharmaceutical industries. “This nomination is a meaningful milestone, not only for me personally but for the entire Sunresin team,” said Ivy Gao, Sunresin’s CEO. “We are working on several exciting launches and strategic initiatives aimed at revolutionizing the life sciences industry. Our goal is to continue driving innovation in resin technologies for life sciences and deliver real impact for our partners and the global biopharma community.” The Sunresin team will attend the CPhI Awards Gala to celebrate this important moment and show their support for Ivy’s nomination. The nomination recognizes Dr. Ivy Gao’s visionary leadership and her role in building Sunresin into a global life sciences company. Sunresin CEO Ivy Gao nominated for “Women of the Year” at CPHI Awards 2025 Interview with Ivy Gao - Sunresin Congratulations on your nomination for CPHI’s Women of the Year award! What was your first reaction when you heard the news? I was honestly surprised and deeply touched. I didn’t expect this nomination, and it feels like a special recognition for me and for everyone who has been part of Sunresin’s journey. Building this company from the ground up has been a collective effort, and seeing that work acknowledged on a global stage means a lot. In your time in the life sciences industry, how has the role/ perception of women in leadership shifted? Have you noticed any distinct shifts? Over the years, I have seen a clear and encouraging shift. There is now more space for women to lead with their own voices and approaches. In the past, many felt pressure to adapt to leadership models that didn’t always reflect their strengths. Today, more women are stepping into leadership roles with confidence and authenticity, and organizations are recognizing the value of different perspectives. It’s a positive change, although there is still more work ahead to ensure equal opportunities. If you had anything to say to women and girls looking to go into leadership, what advice would you give them? Believe in your vision, even if it seems far away. Every meaningful journey starts with a single step,
11 DAILY NEWS CPHI 2025 FRANKFURT DAY 1 | 28th October 2025 and perseverance often makes the difference. Surround yourself with people who share your values and push you to grow. And don’t be afraid to build something from scratch, because sometimes the most rewarding paths are the ones you create yourself. Sunresin recently made a big investment in an industrial park in Pucheng. Can you tell us a little bit about what this facility will be capable of? The Pucheng facility is a major milestone for Sunresin. It will significantly increase our production capacity and give us the flexibility to respond faster to the needs of the life sciences industry. With this site, we can scale up manufacturing and bring new resin technologies to the market more quickly. It reflects both growth and a stronger commitment to supporting our partners around the world. Can you tell us a little more about Sunresin’s life sciences growth strategy? What areas do you see as particularly interesting? Our strategy combines global expansion with technological innovation. We see strong growth in areas such as antibody purification, oligonucleotides, and peptides, which are becoming increasingly important in modern bioprocessing. By strengthening our global footprint and investing in new capabilities, including the Pucheng site, we aim to support these emerging modalities more efficiently and build long-term partnerships with our customers. The life sciences industry is everchanging. Do you have your eye on any burgeoning technologies of interest? Yes, definitely. I’m particularly interested in technologies that improve efficiency, sustainability, and scalability. Automation and continuous processing are changing how manufacturing is approached. We are also seeing exciting progress in advanced purification methods, which will play an important role in making complex biologics more accessible. How would you characterize your leadership style? Are there any areas you place specific emphasis on? I believe in leading by example and staying close to the team. Clear communication and shared goals are essential, but so is giving people the space to grow and contribute their ideas. I value collaboration, transparency, and focus. My role is to set the direction and support the team, while trusting them to bring their best. NEWS
NEWS Sunresin New Materials Co., Ltd. has announced plans to invest USD 160 million in the construction of a High-End Life Science Advanced Materials Industrial Park in the Pucheng High-Tech Industrial Development Zone, China. The project will span approximately 18 hectares and serve as a flagship facility for the development and largescale production of critical bioprocessing materials, including: - Agarose and polymeric chromatography media - Enzyme carriers - Resins for oligonucleotide and peptide solid phase synthesis - Adsorption resins and separation materials - GMP facility for manufacturing APIs and excipients - Resins for ultrapure water production - Food- and biopharma-grade resins - Chromatographic equipment This investment highlights Sunresin’s strategy to grow its life sciences business, meet the increasing global demand for downstream processing solutions, and solidify its standing as a leading innovator in the field. “The creation of this new industrial park reflects Sunresin’s confidence in the long-term growth of the life sciences sector,” said Dr. Ivy Gao, CEO of Sunresin. “By expanding our capacity and capabilities, including a new GMP facility for the manufacturing of APIs and excipients, we aim to provide the global biopharmaceutical industry with more reliable, high-performance chromatography resins and separation technologies.” Although the initiative may not affect financial performance immediately, it positions Sunresin to take advantage of emerging opportunities in biopharmaceuticals, advanced therapies, and global downstream processing. According to the company, land acquisition will take place through a public auction, and construction and development are subject to the usual regulatory approvals. Sunresin announces USD 160 million investment to build state-of-the-art life sciences industrial park in Pucheng
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From discovery to dose: Advancing small molecule and highly potent platform drug substance In 2025, CordenPharma reinforced our Small Molecule Drug Substance capabilities with major investments designed to meet growing customer demand. In Liestal (CH), we are wrapping up a fiveyear facility renovation to expand purification and small-scale development capacity. Our Chenôve (FR) site now features new 6,000 L reactors with enhanced isolation and drying capability, while our Bergamo (IT) facility added a 12,000 L multi product, state-of-the-art manufacturing line, plus upgraded warehousing and increased hydrogenation infrastructure. These enhancements provide customers with substantial, ready-to-use capacity for both standard and highly potent small molecule APIs. Our small molecule drug substance services guide innovators through every stage of API development, from route scouting and process optimization to purification, micronization, solidstate design, and continuous flow chemistry. By addressing complex chemical, stability, and bioavailability challenges early, we reduce risk, accelerate timelines, and ensure scalable, highquality supply. Solid-state optimization remains central to our approach. We support customers with polymorph screening, salt and co-crystal selection, solubility testing, and tailored crystallization development designed to deliver robust APIs that perform reliably in downstream formulations. Advanced analytical tools, including DSC, TGA-FTIR, DVS, particle size distribution, and X-ray diffraction, provide the data needed to move confidently through development and regulatory review. For highly potent APIs, our US Colorado facility offers secure, scalable containment for APIs with occupational exposure limits as low as 0.05 µg/m³. By combining process optimization and purification under cGMP, we deliver high potency APIs with minimal risk and maximum reliability from early clinical supply to commercial scale. At Chenôve (FR), our Flow Chemistry Centre of Excellence enables customers to tackle complex reactions that are challenging in batch mode, including electrochemistry and photochemistry, opening access to a wider range of molecules faster and more efficiently. 16DAILY NEWS CPHI 2025 FRANKFURT DAY 1 | 28th October 2025
CordenPharma Purification solutions across our network span crystallization, preparative chromatography, Supercritical Fluid Chromatography (SFC), and Tangential Flow Filtration (TFF). All technology transfers follow a risk-based, Quality by Design (QbD) approach, with small-scale trials and Design of Experiments (DoE) ensuring reproducible, compliant scale-up. By combining deep expertise, expansive capacity, and strategically located facilities across Switzerland, France, Italy and the US, we help innovators advance their non-potent and highly potent small molecule drug substance efficiently and reliably, delivering the supply and support needed to bring medicines from discovery to patients. Bringing molecule to market: Small molecule and highly potent platform drug products In 2025, CordenPharma has expanded Small Molecule and Highly Potent Drug Product services to meet growing global demand. Our Plankstadt (DE) facility now features a medium-scale Oral Solid Dosage (OSD) line capable of handling both non-potent and highly potent compounds with OEL levels as low as <0.05 µg/m³. This line bridges small- and large-scale capacities, supporting early-stage development as well as clinical and commercial manufacturing, addressing formulation challenges, enhancing bioavailability, and enabling production of complex OSD products. Flexible dosage forms such as minitablets and precision capsule filling facilitate adjustable dosing and modified release profiles, ensuring safe, accurate, and efficient delivery from first-in-human studies to commercial supply. In Lisbon (PT), new roller compactors and tablet coaters enhance formulation flexibility, while additional oral liquid filling lines at Fribourg (CH) provide efficient supply for diverse dosage forms. Both Lisbon and Fribourg have extensive primary and secondary packaging capacities to provide full, end-to-end manufacturing and distribution capability with experience supplying to over 70 countries worldwide. Selecting the right partner for OSD drug product development and manufacturing is critical. CordenPharma accompanies your products across the entire lifecycle, from early phase formulation development and clinical supply through latestage registration, validation, and commercial manufacturing. We handle APIs with OELs down to the picogram per cubic meter level and support both small molecules and peptides. Our structured approach incorporates biopharmaceutic principles for early phase screening, compatibility assessments, and scalable process development. 17 (CordenPharma Photo) Small Molecule API manufacturing facility in CordenPharma Chenôve (FR). DAILY NEWS CPHI 2025 FRANKFURT DAY 1 | 28th October 2025
With expertise in blending, dry and wet granulation, tablet compression, coating, encapsulation, and more, we deliver immediate or modified release forms across tablets, capsules, minitablets, granules, and pellets. Phaseappropriate, science-driven, risk-based process development, technology transfers, and analytical support ensure smooth scale-up from hundreds of grams to commercial production, meeting global regulatory standards. Working closely with our Solid State Centre of Excellence, we provide fully integrated API and Drug Product services, creating a continuous feedback loop to identify the optimal API form for absorption, solubility, stability, and processability. From developability assessments to technology selection, screening studies, prototype development, and Accelerated Stability Assessment Programs (ASAP), we move products efficiently into First-in-Human (FIH) studies and beyond. Our oral peptide delivery services complement robust peptide drug substance offerings, providing end-to-end integrated supply. Absorption is enhanced through strategies such as increased lipophilicity, reduced degradation, and improved membrane permeability, combined with formulation technologies including permeation enhancers, SMEDDS, and LNP carriers. These capabilities ensure reliable progression from early development through commercial supply. 18 Dr. STEPHEN HOULDSWORTH Global Head, Small Molecules Platform CordenPharma International Visit CordenPharma at CPHI Frankfurt 2025 Stand 6.0A24 to learn more! (CordenPharma Photo) Fluid bed processing for Small Molecule OSD manufacturing at CordenPharma Plankstadt (DE). DAILY NEWS CPHI 2025 FRANKFURT DAY 1 | 28th October 2025 CordenPharma Small Molecules Technology Platform Highly Potent & Oncology Technology Platform Read more about our bioavailability enhancement
Introduction: The rising complexity of small molecule development The development of small-molecule therapeutics has never been more complex. Pharmaceutical researchers are faced with molecules with higher molecular weight and increasing 3D character. At the same time, regulatory expectations are rising, market competition is intensifying, and patient needs demand more rapid development timelines. In this context, leveraging early-phase, data-driven strategies is essential for accelerating drug development while mitigating risk. Once a target molecule has been identified, determining an optimal synthetic route as early as possible can help ensure long-term process feasibility and reduce overall risk. By integrating advanced tools from the earliest stages of development, drug developers can not only identify synthetic routes more quickly but also incorporate realworld data into route design. Modern approaches allow researchers to comprehensively explore possible synthetic processes, determining the most efficient, scalable, and reliable route before substantial resources are invested in preclinical or clinical manufacturing. Synthetic processes that perform well in the lab may present challenges when scaled to preclinical or commercial volumes. For instance, a high-yielding reaction may be safe at laboratory scale, but scaling it for commercial production introduces significant safety and regulatory challenges, requiring specialized controls and equipment. By keeping downstream needs in mind from the outset, pharmaceutical developers can avoid costly process adjustments and delays during later stages of development. Designing smarter routes: AI-enabled route scouting Retrosynthetic analysis is a foundational step in smallmolecule development. While traditional methods focus on identifying the shortest, most reliable route, modern approaches consider additional constraints such as raw material availability, cost, and scalability. Lonza’s Advanced Synthesis Business Platform integrates AI-enabled computer-aided synthesis planning (CASP) with real-world supply chain and pricing data. This approach allows drug developers to assess routes not only for theoretical efficiency but also for process feasibility and economic viability beyond the lab. Predictive insights into pricing and supply chain reliability enable researchers to anticipate potential disruptions due to geopolitical tensions, natural disasters, or raw material shortages, mitigating risk before scale-up. By incorporating these tools early, emerging biotech companies can increase readiness for IND (Investigational New Drug) applications. Evaluating routes comprehensively before clinical and commercial manufacturing also minimizes risks during later-stage process development. 20DAILY NEWS CPHI 2025 FRANKFURT DAY 1 | 28th October 2025
LONZA Accelerating development through experimentation and data Once potential synthetic routes are identified, researchers must optimize process chemistry. High-throughput experimentation (HTE) allows many reactions to be conducted in parallel under varying conditions, providing rapid insights into optimal reagents, solvents, and reaction parameters. This approach reduces time, effort, and resource requirements compared to traditional iterative trial-and-error methods. HTE requires specialized expertise, robotics, and analytical instruments. Lonza’s dedicated robotics system enables automated, round-the-clock experimentation across a wide range of reaction conditions. By conducting smallscale reactions in 96-well plates and scaling promising options to 20 mL, researchers gain comprehensive insights into reaction kinetics and scalability. For highly potent APIs, specialized glovebox and purge systems allow safe experimentation under low-moisture, lowoxygen conditions. HTE accelerates the development of robust synthetic routes while mitigating scale-up risks, in particular when combined with AI route scouting. Statistical design of experiments and Design2Optimize™ Optimizing process chemistry requires understanding how multiple variables interact. Traditional methods of changing one variable at a time fail to capture these interactions. Statistical Design of Experiments (DoE) is a well-established method that provides a structured approach to evaluate multiple parameters simultaneously, identifying critical process parameters (CPPs) that may influence yield, purity, and stability. Lonza’s proprietary Design2Optimize™ platform extends DoE principles by integrating existing experimental data with physicochemical modeling. This reduces the number of experiments required to optimize reactions while providing predictive insights into complex chemistries. Researchers can model the impact of temperature, pH, and other parameters, creating a digital twin of the synthetic process. This enables exploration of hypothetical scenarios, such as adjusting process conditions to maximize yield, but also the multiobjective optimisation of parameters vs multiple targets without additional experimental work (e.g. aiming to achieve a sweet spot for yield and cycle time). Solid form screening Solid form selection is a critical early-phase decision, often sitting on the critical path to IND with profound downstream implications. The physical form of an active pharmaceutical ingredient (API), including salts, polymorphs, hydrates, solvates, and amorphous solid dispersions (ASDs) can impact solubility, stability, and bioavailability. Early identification of the optimal solid form ensures consistent performance, regulatory compliance, and intellectual property protection. Salts or crystal coformers are, for example, often used to improve the bioavailability of poorly soluble compounds. However, the robust selection of the appropriate solid state requires extensive solid form screening, including evaluation of stability, solubility, polymorphism, etc. Failures at this stage can lead to significant delays, as evidenced historically by drugs like ritonavir, where solid-state issues required costly reformulation and regulatory approval. Lonza’s approach to solid form screening integrates automated workflows and high-throughput capabilities, allowing multiple solid forms and formulations to be assessed simultaneously. This comprehensive strategy ensures that the most promising candidates are identified early, reducing downstream risk and accelerating the path toward clinical development. In particular, Lonza has recently enhanced its toolbox with a new AI enhanced conformer selection tool enabling the identification of the most likely co-formers for any API. This predictive approach can significantly reduce the number of experiments by guiding screen design and enhance probably of success of identify of suistable solid state form of the API in record time. Understanding behavior in the body: Physiologically Based Biopharmaceutics Modeling (PBBM) Once a stable and bioavailable solid form has been selected, understanding how the molecule behaves in vivo is the next step. PBBM offers a powerful predictive tool to simulate how a drug will distribute, metabolize, and eliminate in humans. Unlike traditional PK studies, PBBM integrates physiological, chemical, and biochemical data to predict drug behavior across different populations, including pediatric and elderly patients, and under varied dosing conditions. By incorporating absorption, distribution, metabolism, and excretion (ADME) data, PBBM can identify potential challenges early, such as food-drug 21 DAILY NEWS CPHI 2025 FRANKFURT DAY 1 | 28th October 2025
hypothetical scenarios and process modifications before experimentation. Insights gained early inform laterstage development, such as scale-up and commercial manufacturing, ensuring that processes remain robust, scalable, and cost-effective. The ability to offer full digital technology transfer and manufacturing capabilities from lab to plant beyond current MES and LIMS system is also opening a wide range of opportunities for acceleration and optimisation of manufacturing of pharmaceuticals. Toward a data-driven development paradigm in early phase The convergence of AI-enabled route scouting, HTE, model-based process optimization, solid form science and PBBM, is transforming small-molecule drug development. By adopting a data-driven, integrated approach, drug developers can accelerate timelines, mitigate risk, and improve long-term process reliability. This data/model driven scientific approach may appear counter intuitive in a field where speed and trials and error approaches have dominated for years. However, recent advances in early-phase tools and capabilities now make it possible to take a more insightful yet pragmatic approach to drug development, enabling faster progress by avoiding challenges such as poorly developed or convoluted processes and suboptimal solid-state selection. Early-phase decisions are no longer isolated tasks; they are interdependent steps that shape the efficiency and success of later development. Lonza’s tools and expertise empower biotech and pharmaceutical companies to adopt a “right-first-time” mindset, ensuring that every decision from solid form selection to scale-up is informed, strategic, and resilient. As the complexity of small molecules continues to grow, this integrated approach provides a competitive advantage, supporting faster access to life-saving therapies while optimizing costs and timelines. If you would like to learn more, join Francois Ricard’s presentation on Smarter Molecule Development: AIDriven Tools and Model-Based Approaches in EarlyPhase on Wednesday, October 29, 2025, from 2:30–2:55 PM (CET) in Hall 4.1 - 4.1L8, Manufacturing 5.0, or stop by our booth 5.1B76 to connect directly with our experts. or acid-reducing drug interactions. For example, in developing posaconazole ASDs, PBBM was used to predict in vivo performance, guiding formulation strategies and dosing regimens. Regulatory agencies increasingly recognize PBBM data in IND applications, underscoring the importance of these models in accelerating clinical readiness. Lonza is at the forefront of deploying PBBM modelling tools such as Gastro+ in the CDMO industry guiding our customers decision and derisking their assets by ensuring appropriate drug exposure. Strategic benefits for biotech and pharma Integrating AI-enabled route scouting, HTE, Design2Optimize™, solid form screening and PBBM tools provides a holistic, data-driven foundation for drug development in early phase and forms the first wave of a digital design and optimisation toolbox being built at Lonza to enable our customers’ drug to reach the market faster. Key benefits include: - De-risking early development: Identifying optimal routes, formulations, and process parameters early reduces the likelihood of delays during scale-up. - Accelerating timelines: Faster process optimization and predictive modeling shorten the path to IND submission and clinical trials. - Cost efficiency: By selecting commercially viable routes and formulations early, developers reduce potential losses from late-stage failures. - Investor confidence: Robust, data-backed processes demonstrate maturity and reliability to potential investors and partners. Looking beyond process chemistry With the remarkable growth in AI and predictive tools, Lonza’s integrated approach is being extended well beyond chemistry optimization. In the optimisation area, the combination of highthroughput screening combined with learning tools like D2O, Bayesian optimisation or AI are driving a paradigm shift towards self-optimising platform in process development. In the technology transfer and manufacturing areas, digital twins of synthetic processes already allow exploration of 22 Dr. FRANCOIS RICARD Executive Director, R&D Lonza Advanced Synthesis LONZA DAILY NEWS CPHI 2025 FRANKFURT DAY 1 | 28th October 2025
24DAILY NEWS CPHI 2025 FRANKFURT DAY 1 | 28th October 2025 CPHI PHARMA AWARDS Informa Markets, has announced the shortlist for the CPHI Pharma Awards 2025, recognising outstanding achievements across pharmaceutical innovation, manufacturing, sustainability, leadership and women in pharma. The awards spotlight the companies and individuals pushing the boundaries of science and technology to advance global healthcare. The CPHI Pharma Awards finalists for 2025 include innovators redefining everything from synthetic biology and AI-powered formulation to patient access, circular packaging, and leadership in rare diseases, spotlighting the most transformative work happening in the industry today. This year’s shortlist also celebrates the next generation of pharmaceutical changemakers through the Future Leader and Women in Pharma categories, spotlighting individuals whose impact and vision are reshaping the industry from within. “We’ve been incredibly impressed by the quality, originality, and ambition of this year’s submissions. Across every category, the finalists are setting new standards in pharmaceutical innovation, sustainability, and patient impact. The CPHI Pharma Awards are a vital platform to spotlight the progress shaping the future of our industry. We’re looking forward to celebrating these achievements and announcing the winners on the opening day of CPHI Frankfurt.” Tara Dougal, CPHI Event Director, Informa Markets. The winners will be revealed during an exclusive networking reception today, October 28. FINALISTS ANNOUNCED Hundreds of entries received across 14 categories showcasing innovation, sustainability, and leadership in pharma The full list of 2025 finalists is available by category below. Further information on each finalist can be found at www.cphi.com/europe/en/cphi-celebration/awards.html API Development and Innovation - Lonza: Design2Optimize(™) - CMAC: From Crystallisation to tablet: A scalable Platform for API Agglomeration. - Merck KgaA: mPredict Co-crystal Prediction Service - CordenPharma International: TAPS: TAG Assisted Peptide Synthesis.
25 DAILY NEWS CPHI 2025 FRANKFURT DAY 1 | 28th October 2025 CPHI PHARMA AWARDS Accelerating Innovation - NunaBio Ltd: Custom, cell-free, synthetic DNA - TriLink Biotechnologies: GMP-Grade CleanCap® M6 Analog - Covestro Deutschland AG: Mono-Material Drug Delivery Demonstrator - Accord Healthcare: Orgovyx - Transforming prostate cancer care - Invengene Private Limited: Room temperature-stable generic Posaconazole Injection Using Hydroxypropyl beta-cyclodextrin (HPβCD) - Prestige BioPharma: Ullenistamab: A Targeted MAB for pancreatic cancer At the Heart of Pharma - Accord Healthcare: A decade of impact with International Health Partners (IHP) - PharmEvo Pvt. Ltd: Elevating patient safety through intelligent design - Strides: Enhancing access to affordable healthcare - HIV - Farmak International: Resilient by Design: Farmak Group’s Ukrainian-rooted pharma network blueprint for crisis-proof global supply - CNX Therapeutics and the Social Mobility Foundation: Talent without barriers Drug Delivery and Device Innovation - Azelis Group NV: Advanced Peristomal Barrier & Adhesion Cream - SHL Medical: Maggie® Mix: A dual-chamber autoinjector with Needle Isolation Technology (NIT®) - LTS Lohmann Therapie Systems AG: Launching the first biosimilar in an on-body injector - Ypsomed: Uniting sustainability and patient convenience in self-injection devices Finished Formulation - Zerion Pharma A/S: Dispersome® technology - Evonik Industries AG: EUDRACAP® colon: The world’s first functional ready-to-fill capsule for oral drug delivery to target the ileo-colonic region - CrystecPharma: Modified Supercritical Anti-Solvent (mSAS®) particle engineering for stabilisation of biomolecules - Roquette: ReadiLYCOAT® Plant-Based Coating Systems for enhanced oral dosage solutions - Lonza Capsules & Health Ingredients: Innovaform® Innovation and formulation accelerator. Woman of the Year - Adriana Kiędzierska-Mencfeld, Polpharma Biologics - Christiane Bardroff, Rentschler Biopharma - Ivy Gao, Sunresin - Jennifer Gattari, Pfizer CentreOne - Jonina Gudmundsdottir, Coripharma - Meeta Gulyani, Ecolab Life Sciences Start-Up Initiative - Green Elephant Biotech: CellScrew® - NunaBio Ltd: Custom: Cell-free, synthetic DNA - including high complexity sequences, multi kilobase length and milligram scale - made in days to weeks - NovoArc GmbH: Lipids for innovative drug formulation - ORYL Photonics: ORYL F1
26DAILY NEWS CPHI 2025 FRANKFURT DAY 1 | 28th October 2025 CPHI PHARMA AWARDS Packaging and Machinery - SCHOTT Pharma: SCHOTT TOPPAC® infuse – the next generation - IMA LIFE: TILE-X: New generation gloveless aseptic fill-finish system - H&T Presspart: Vytal® innovative RTU snap-fit closure Supply Chain Excellence - Cryoport Systems: Integrated end-to-end supply chain platform - Occam Systems: Resilient chemical supply chains, supercharged by AI - QYOBO GmbH: QYOBO platform - TraceLink: TraceLink Orchestration Platform for Universal Solutions (OPUS) Sustainability - Celtic Renewables: Leading the Green Chemical Revolution, transforming industrial by-products into highvalue green chemicals. - Enantios: Enantios platform - Enabling fast, label-free chiral analysis in solution - Avantor: J.T.Baker® Viral Inactivation Solution – Environmentally safer detergent for virus removal in bioprocessing - AustinPx: KinetiSol™ Technology, a solvent-free, fusion-based technology that transforms poorly soluble drugs into high-bioavailability formulations - Kindeva: Leading the way in next-generation propellants (NGPs) - commercial-ready capabilities in HFA152a and HFO1234ze propellants. - Alliance to Zero: Lean, Green and Secure, a regulatory-ready, blister-free, syringe solution - Huhtamaki: Omnilock™ Ultra PAPER - Botanical Solution Inc. (BSI): Sustainability Grows on Trees: Producing QS-21, the Gold Standard vaccine adjuvant CEO of the Year - Bobby Sheng: Bora Pharmaceuticals - Deepak Bahri: Sentiss Pharma - Hanns-Christian Mahler: ten23 health - Lars Petersen: FUJIFILM Diosynth Biotechnologies - Lisa Soyeon Park: Prestige Biopharma - Michael Quirmbach: CordenPharma International Future Leader - Jakub Knurek: Mabion - Mark Kelada: Nelipak Laboratory Services - Mohammad Farahani: CinnaGen - Yolanda Gomez: Esteve CDMO - Yuvansh Khokhani:YSK Laboratories Pvt Ltd Manufacturing Excellence - Coriolis Pharma Research GmbH: Advanced lyophilization modelling - Enzene: EnzeneX™: Fully-connected continuous manufacturing™ - Bausch+Ströbel SE + Co. KG: GENEX, robotic, modular aseptic fill-finish platform - VectorBuilder: VectorBuilder’s gene drug manufacturing platform
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