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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 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. 2 CPHI FRANKFURT 2025 PREVIEW
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, 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 3 CPHI FRANKFURT 2025 PREVIEW banner SUNRESIN ANIMATO
Novo Nordisk announced plans to acquire Akero Therapeutics, a clinical-stage biotechnology company developing treatments for serious metabolic diseases with high unmet medical need, in a deal worth up to $5.2 billion. The acquisition will grant Novo Nordisk the rights to Akero’s fibroblast growth factor 21 analogue efruxifermin (EFX), a MASH treatment currently in Phase III development for the treatment of patients with moderate to advanced liver fibrosis and patients with cirrhosis. According to a company press release, Novo Nordisk will acquire all outstanding shares of Akero’s stock for $54 per share, or an approximate value of $4.7 billion. An additional payment of $6 per share (approximately $500 million) is contingent on US regulatory approval of EFX. The deal is expected to close around the turn of the year. EFX is currently being evaluated as a once-weekly subcutaneous injection in the Phase III SYNCHRONY program. The program consists of three clinical trials evaluating the treatment of pre-cirrhotic MASH and compensated cirrhosis due to MASH. According to the release, two Phase IIb trials previously demonstrated 49% and 29% reduction in fibrosis without worsening of MASH, compared to 19% and 11% in their respective placebo groups. “MASH destroys lives silently - and [EFX] has the potential to change that by reversing liver damage,” said Mike Doustdar, President and CEO, Novo Nordisk, in the release. “If approved, we believe it could become a cornerstone therapy, alone or together with Wegovy (semaglutide), to tackle one of the fastest-growing metabolic diseases of our time. This acquisition embodies Novo Nordisk’s relentless ambition to move faster, go further, and ultimately deliver on our commitment to pursue leadership in diabetes, obesity and their associated comorbidities.” “[EFX] complements Novo Nordisk’s leading portfolio and is aligned with our commitment to building a competitive portfolio of treatment options across the stages of MASH. Within MASH, there remains a huge medical need for effective treatment options, especially in the later stages of the disease,” said Martin Lange, CSO and executive vice president of Research & Development, Novo Nordisk, in the release. “Based on the data generated by Akero, we believe [EFX] could be a first- and best-in-class treatment for mid- to late-stage MASH with the potential to reverse liver damage. Novo Nordisk is uniquely positioned to unlock the full potential of [EFX] and reach more patients living with MASH.” Novo Nordisk to acquire Akero Therapeutics in deal worth up to $5.2 billion 4 NEWS CPHI FRANKFURT 2025 PREVIEW
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 GLP-1 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 5 Go further with Axplora. Your co-pilot for APIs, ADCs and peptides. Meet us at Hall 11.0 Booth B48 and Dare To Imagine. CPHI FRANKFURT 2025 PREVIEW
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8 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. CPHI FRANKFURT 2025 PREVIEW
9 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 CPHI FRANKFURT 2025 PREVIEW
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 10CPHI FRANKFURT 2025 PREVIEW
NEWS Lonza expands its TheraPEAK® product portfolio with the addition of AmpliCell® Cytokine range and TheraPEAK® 293-GT® Medium Lonza, one of the world’s largest contract development and manufacturing organizations (CDMOs), today announced the launch of TheraPEAK® AmpliCell® Cytokines and TheraPEAK® 293GT® Medium to expand its GMP solutions for cell and gene therapy. Cytokines represent a critical component in cell therapy manufacturing, supporting the expansion and maintenance of living cells. TheraPEAK® AmpliCell® Cytokines enable the reliable expansion, activation, and differentiation of immune cells. Produced in a mammalian expression system and engineered for high biological activity, these cytokines feature proper folding and glycosylation, delivering native-like structure and function that bacterial systems cannot match. This ensures superior biological relevance, batchto-batch consistency, and greater predictability in sensitive and translational applications, both in research and GMP set-ups. TheraPEAK® 293-GT® Medium is a chemically defined, animal–origin– free system optimized for adenoassociated virus (AAV) production in suspension HEK293 cells, providing a reliable, scalable option for advancing gene therapy programs. Unlike off-the-shelf viral production kits that may lack flexibility, the 293-GT® System (growth medium plus supplement) is a drop-in-ready solution engineered to integrate seamlessly with existing workflows. The media is compatible with commercially available transfection reagents and AAV enhancers, delivers strong AAV titers, and supports high full-to-empty capsid ratios. TheraPEAK® Products have been used in FDA-approved therapies and more than 130 clinical trials across the globe. The newly-added solutions provide researchers and manufacturers with highperformance, scalable, and regulatory-ready solutions that streamline cell and gene therapy workflows from discovery through clinical development. Mike Goetter, Head of Bioscience, Specialized Modalities, Lonza, said: “The introduction of AmpliCell® Cytokines and the 293-GT® Medium to our TheraPEAK® Range greatly enhances our offering for cell and gene therapy customers, providing them with reliable solutions to support their drug development efforts.” TheraPEAK 293-GT media system for suspension HEK203 cell lines. TheraPEAK AmpliCell Recombinant Interleukin Cytokines 12 BANNER LONZA ANIMATO CPHI FRANKFURT 2025 PREVIEW
NEWS Almac trial coordinator launched in $48 million investment to advance integrated eClinical technologies Almac Group has today announced a $48 million investment in eClinical technologies that includes the launch of Almac Trial Coordinator™ – a firstin-class interoperable clinical trial technology platform, enhancements to its eClinical ecosystem capabilities, and creation of over 100 advanced technology roles globally. This investment addresses the top technology challenges facing sponsors, CROs, and clinical sites through the solution’s marketdisrupting and interoperable approach to integration, enabling high-quality, efficient trials with full visibility, reduced risk, and enhanced patient engagement. Almac Trial Coordinator™ is purpose-built to unify operational processes, clinical data, and systems into one unified protocol. The platform is novel due to its unique ability to meet the industry’s pressing and unmet system fragmentation challenge, offering both standardisation and flexibility where trials and data providers differ. This supports sponsors in futureproofing their technology strategy, eliminates vendor lock-in, and greatly expands the number of sites capable of meeting the demands of modern clinical trials. The platform features open APIs and standards-based exports to fit modern tech stacks to ensure interoperability for its users- offering full visibility across connected solutions and supporting fast, low-disruption protocol amendments through controlled workflows. “This investment underscores our commitment to delivering flexible, scalable solutions that empower sponsors and sites to run complex trials with confidence and efficiency,” said Valarie Higgins, President & Managing Director at Almac Clinical Technologies. “Almac Trial Coordinator™ is a transformative solution with a unique focus on streamlining the site’s ability to navigate today’s eClinical ecosystem with confidence and ease- addressing a critical industry need that does not get enough attention.” Kees van Ooik, Vice President of eClinical Solutions, added: “Our vision is to simplify complexity and deliver measurable value through an integrated eClinical ecosystem. This investment enables us to enhance interoperability, improve user experience, and meet the evolving needs of global clinical trials.” video CPHI FRANKFURT 2025 Preview with Tara Dougal - Event Director 13 CPHI FRANKFURT 2025 PREVIEW
CordenPharma Driving innovation and leadership: CordenPharma shortlisted for two CPHI Pharma Awards environmentally burdensome, and limited in worldwide production capacity. TAPS solves this by combining the control of SPPS with the scalability of LPPS, eliminating resin use, reducing solvent consumption by over 90% and substantially reducing the amount of raw materials used. The peptide remains in the organic phase via a patented TAG-anchor molecule while impurities and excess amino-acid derivatives or reagents are extracted into the aqueous phase. CordenPharma is very proud to be shortlisted as a finalist in two categories at the CPHI Awards 2025! The CPHI Pharma Awards celebrate the forefront of innovation, excellence, and collaboration in the pharmaceutical industry. These prestigious awards honor pioneers driving advancements in drug development, revolutionizing manufacturing processes, championing sustainability, and shaping the future of pharma worldwide. Against this backdrop, CordenPharma is proud to be shortlisted as a finalist in two categories at the CPHI Awards 2025 - API Development & Innovation and CEO of the Year - which recognize both our innovative technology and leadership in combining deep scientific expertise with a commitment to improving patient outcomes. We are shortlisted for our Tag-Assisted Peptide Synthesis (TAPS), a next-generation technology revolutionizing peptide manufacturing to meet the growing demand for scalable and sustainable peptide outsourcing. Indeed, the global peptide therapeutics market is expanding rapidly, driven by biologically active peptides like GLP-1 analogues. However, current manufacturing technologies, particularly SPPS, are resource-intensive, API development and innovation 14CPHI FRANKFURT 2025 PREVIEW
CordenPharma This allows for continuous solution-phase synthesis with simple aqueous workups. The organic phase is then carried over for the next coupling and cleavage cycle. Compared to SPPS, TAPS improves efficiency, sustainability, and scale. It eliminates resin handling, drastically cuts solvent use, and simplifies purification. Unlike LPPS, TAPS retains precise stepwise control, allowing full compatibility with SPPS reagents and know-how. TAPS provides a greener, more economical alternative that integrates into existing smallmolecule assets, enabling broad application without investment in peptide-specific hardware. This innovation opens the door for automation, modular synthesis (fragment approaches), and green manufacturing practices. It directly supports pharmaceutical trends toward flexible, scalable production of complex, high-value APIs under increasing regulatory scrutiny. TAPS is not just a lab-scale improvement - it’s an industrial innovation ready for GMP rollout, with clear benefits for pharma innovators. Figure 1. (CordenPharma Photo) Preparation of peptide synthesis using TAPS technology at CordenPharma Liestal (CH). CordenPharma CEO & President Dr. Michael Quirmbach stands out among the finalists thanks to his visionary leadership, not only to drive business success, but also to support pharmaceutical innovators in advancing the care of their global patient communities with impactful outsourcing innovations. His ambitious goal is to position CordenPharma among the top five CDMOs globally, recognized for its unwavering commitment to customer centricity and scientific excellence. CEO of the Year Dr. MICHAEL QUIRMBACH CEO & President CordenPharma Group 15 CPHI FRANKFURT 2025 PREVIEW
Since joining CordenPharma over a decade ago as VP, Head of Marketing & Sales, Michael has been instrumental in transforming the company from a collection of independent sites into a globally integrated organization. Over the past eleven years, Michael has navigated CordenPharma through key transitions, including site acquisitions, divestitures, transitioning to new shareholders, and substantial CAPEX investments. Over the coming years, he continued to drive cutting-edge projects to meet evolving market, customer, and patient needs, and grew the company from €245 million in sales in 2014 to a projected €1 billion in 2025. CordenPharma’s manufacturing capacity and capabilities expansion is not only focused on meeting growing market demand but also on addressing some of the most pressing unmet medical needs. A significant part of this effort is dedicated to rare diseases, a field where 300 million patients worldwide often face limited treatment options. Here, Michael is the driving force behind CordenPharma’s commitment to advancing innovators’ research with effective manufacturing solutions for several rare diseases, such as Acute Myeloid Leukemia, Rett Syndrome, Cystic Fibrosis, Fragile X Syndrome, Gaucher Disease, Huntington’s Disease, and Idiopathic Pulmonary Fibrosis. During the COVID-19 pandemic, Michael’s leadership was instrumental in CordenPharma’s rapid response to supply critical Lipids for mRNA vaccines, helping accelerate the global vaccine rollout by guiding the tireless efforts of global CordenPharma teams with vigilance, positivity and dedication. Building on this success, CordenPharma, together with WACKER, were awarded a Pandemic Preparedness contract by the German government - a strategic initiative to secure future vaccine production in response to potential shortages - where both companies committed to maintaining production readiness for mRNA-based vaccines, and ensuring the capability to manufacture 80 million doses annually within an extremely short timeframe, in the event of a new pandemic. This reinforces CordenPharma’s role as a key partner in global health security, safeguarding future vaccine accessibility. For Michael and CordenPharma’s shareholders, expansion can’t happen at the expense of the environment. As members of the Science-Based Targets initiative (SBTi), CordenPharma is committed to a sustainability plan that allows for complex expansion while actively pursuing nearterm carbon emission reduction targets in line with a 1.5° C trajectory. Finally, what truly sets Michael apart as an extraordinary leader, is his deep commitment and passion for building a leading CDMO grounded in core values (accountability, collaboration, integrity, trust and reliability) as well as strong operational pillars. Throughout his journey in the organization, he discovered that his greatest source of enthusiasm comes from working alongside expert teams across our sites - teams that keep the end goal in mind: supporting innovators and, ultimately, the patients they serve. It is this tireless passion and deep commitment - not just to business success, but to making a tangible impact on the industry and patient care - that makes Michael an extraordinary CEO. Being a finalist in both API Development & Innovation and CEO of the Year categories of the CPHI Awards highlights not only CordenPharma’s scientific and operational achievements, but also our steady commitment to supporting innovators and improving patient outcomes. These nominations are both a milestone and a motivation - to continue advancing technologies like TAPS, to expand our global CDMO capabilities, and to lead with purpose and responsibility in an evolving healthcare landscape. We look forward to celebrating with all the finalists at the awards evening on October 28th in Frankfurt! CordenPharma 16CPHI FRANKFURT 2025 PREVIEW
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THE CHEMISTR CHEMISTRY WITH A HUMAN TOUCH. 1 with care Act 4Make it simple Transform our values into everyday elements: let these pri decisions and actions, thereby contributing to the shared s Responsibility, for us, means taking care of people, ensuring safety, maintaining facilities, ana upholding product quality. It involves valuing differences, learning from mistakes, optimizing processes, and, above all, identifying goals and defining actions while continuously evaluating their human and social impact. Our primary objective is to promote health and well-being worldwide, starting with our community and our customers. Simplicity is the first prerequisite for efficiency. To create value, we base our choices-ranging from the simplest to the most strategic-on measurable data. We aim to make decision-making processes agile and strive to be pragmatic in our daily actions, focusing on what is essential. Simplifying also involves reducing waste and conserving energy, always acting in a direct and clear manner. At FLAMMA, we face challenges daily yet we are guided and inspired by our values that shape our culture. These principles, focused on people, sustainable innovation, our customer, and ecosystem, catalyze our daily work transforming our environment into a community where individual’s contributions fuel collective growth.
2Be open minded 3Get in the game 5Build together 6Be accountable RY OF VALUES We are open to all that embodies the future. We value change as an opportunity for enrichment and growth. We enthusiastically welcome new ideas and people, ready to shift perspectives and experiment with innovative approaches. Driven by curiosity, we strive to overcome challenges through the power of science, creativity, and talent. A dynamic and stimulating work environment is the first step to success. Our productivity is built on commitment, passion, and teamwork. We recognize that a positive work environment is crucial for both professional and personal development. This approach transforms our workspace into a catalyst for well-being, both individually and collectively. We view the time spent together as an opportunity for growth. We collaborate with partners and customers, aiming to work effectively together while cultivating co-creation processes rooted in cooperation, trust, and active listening. Our approach is innovative and inclusive, intertwining perspectives and granting everyone the freedom to share their ideas in a generative environment. Accountability is a key principle at Flamma. It encompasses not only acting with responsibility and reliability but also maintaining clarity and consistency in our interactions with others. Each of us is called to lake full responsibility for our role within the organization and for the responses we provide each day. We promote autonomy and a result-oriented mindset, recognizing the learning value of mistakes and the importance of transparent communication. inciples shape your success of FLAMMA
NEWS Zenas and InnoCare strike $2 billion licensing agreement Zenas BioPharma and InnoCare Pharma announced a license agreement granting Zenas global development and commercialization rights to orelabrutinib for MS globally, as well as all other therapeutic areas other than oncology outside of China and Southeast Asia. Zenas also secured rights to an oral, IL17AA/AF inhibitor and an oral, brain-penetrant, TYK2 inhibitor, both of which are expected to begin Phase I development in 2026. According to a company press release, Zenas will pay $100 million upfront and up to 7 million shares of Zenas common stock issuable upon a milestone expected to be achieved in early 2026. The total value of the deal, including various near-term, development, and regulatory milestone payments, exceeds $2 billion, as well as tiered royalties of up to high teens percentages on annual net sales of the licensed products. Orelabrutinib is a highly selective CNS-penetrant, oral, smallmolecule BTK inhibitor currently being evaluated in a Phase III clinical trial as a treatment for patients with Primary Progressive MS. A second Phase III trial evaluating orelabrutinib in patients with Secondary Progressive MS is expected to begin in Q1 2026. According to the release, in a Phase II trial evaluating treatment of patients with Relapsing-Remitting MS, orelabrutinib demonstrated significant reductions in new T1 gadolinium lesions versus placebo at weeks 12 and 24. Additionally, the treatment demonstrated sustained reductions in inflammatory activity through week 96 as shown by meaningful impact on endpoints indicative of disease progression. “The partnership with Zenas BioPharma represents a significant milestone in our journey, and we will continue to enhance and advance our globalization efforts in the future,” said Dr. Jasmine Cui, Co-Founder, Chairwoman, CEO, InnoCare Pharma, in the release. “Orelabrutinib has a differentiated mechanism of action and strong clinical data underscoring its promising potential as a treatment for patients with progressive forms of MS. We are confident in Zenas’ management team given their exceptional track record of successful drug development, global regulatory approvals and commercial launches, and their commitment to driving innovation for autoimmune diseases.”
MOLCURE, a Japanese biotechnology company specializing in AI-driven drug discovery for antibodies and peptides, announced a multi-year strategic research agreement with Boehringer Ingelheim on October 7th. The deal will see Boehringer implement MOLCURE’s platform technology to speed discovery of antibody therapeutics for multiple undisclosed targets. Financial details of the partnership were undisclosed. According to a company press release, MOLCURE’s proprietary platform is based on a large language model designed for antibody engineering. The partnership will see the companies combine wet-lab data with in silico modeling to enable the design of novel antibody sequences. Per the release, the companies hope that this will accelerate the discovery of antibody candidates relative to traditional processes.“We are delighted that Boehringer Ingelheim has chosen MOLCURE as a partner in recognition of our AI technology’s ability to deliver strong results from limited data,” said Satoshi Tamaki, CEO and CSO, MOLCURE, in the release. “We are excited to work alongside Boehringer Ingelheim’s scientists to further evolve our innovative AI-driven antibody discovery platform and make a significant contribution to their drug discovery programs. I hope that our partnership will lead to new treatments that improve the prognosis and quality of life for patients around the world.” Boehringer and MOLCURE enter antibody research partnership NEWS “BTK inhibition is a validated mechanism for the treatment of progressive forms of MS, and there is immense scientific interest in its potential to impact inflammation compartmentalized in the CNS and thereby potentially impact disability progression independent of relapse activity,” said Lisa von Moltke, M.D., Head of Research and Development, Chief Medical Officer, Zenas BioPharma, in the release. “We believe the differentiated, potentially best-in-class profile of orelabrutinib could make a meaningful difference for patients with PPMS and SPMS, which have few treatment options. With our late-stage development capabilities and expertise in MS, we are well positioned to execute on the pivotal, global, Phase III development of orelabrutinib, as well as advance two early candidates into clinical development.”
LTS expands its CDMO capabilities with the acquisition of Renaissance Lakewood LTS LOHMANN Therapie-Systeme AG (“LTS”), a leading pharmaceutical technology company announced the acquisition of Renaissance Lakewood, LLC (“Renaissance”), a US-based contract development and manufacturing organization (CDMO) specializing in nasal sprays and sterile dosage forms. With the acquisition, Renaissance facilities will become part of the worldwide operations network of LTS, along with LTS’ existing facilities in Andernach, Germany, West Caldwell, NJ, US, St. Paul, MN, US and Netanya, Israel. The acquisition of Renaissance marks a significant milestone in LTS’s strategy to expand its capabilities in the CDMO space. Renaissance brings deep expertise, state-of-the-art manufacturing infrastructure, and a talented workforce of approximately 500 employees. This move enables LTS to offer a broader range of drug delivery solutions and strengthens its position within the CDMO community. Founded in 1979 and currently owned by RoundTable Healthcare Partners, Renaissance is headquartered in Lakewood, New Jersey. The company operates multiple manufacturing suites for unit-dose, bi-dose, multi-dose nasal sprays, and small-volume parenteral fill-finish vials. Its laboratories support R&D formulation development and spray characterization, making Renaissance a comprehensive partner from development through commercial launch. This acquisition aligns with LTS’s commitment to innovation and excellence in drug delivery. By integrating Renaissance’s capabilities, LTS will be better positioned to serve pharmaceutical and biotech partners across a wider spectrum of therapeutic modalities. Bas van Buijtenen, CEO of LTS, commented: “We are delighted to welcome Renaissance Lakewood to the LTS family. This acquisition marks a significant step in our strategy to expand our CDMO capabilities and strengthen our position as a global leader in innovative drug delivery solutions. Renaissance’s expertise in nasal sprays and sterile dosage forms perfectly complements our existing portfolio and will enable us to offer even greater value to our partners and patients worldwide. We look forward to working together to drive innovation and deliver high-quality solutions across a broader range of therapeutic modalities.” Serge Maltais, President & CEO of Renaissance added: “I am incredibly proud of what we have built at Renaissance thanks to the hard work and dedication of our employees. Now, as part of the LTS family, our combined strengths will position us even better to meet the complex needs of our clients and deliver greater value to the industry. We are excited to begin this new chapter and look forward to achieving success together.” The transaction is expected to close before end of November 2025, subject to regulatory approvals. 22 NEWS CPHI FRANKFURT 2025 PREVIEW
AstraZeneca strikes drug pricing agreement with U.S. Government AstraZeneca announced an agreement with the U.S. government to lower the cost of the company’s prescription medicines on October 10th. Public details of the deal mirror the terms of the “most favored nation” agreement Pfizer struck with the Trump administration last month, but full financial details remain confidential. AstraZeneca, based in the United Kingdom, is the first company outside the United States to strike a deal of this nature with the U.S. According to a company press release, AstraZeneca will provide direct-to-consumer sales to eligible patients with prescriptions for chronic diseases at a discount of up to 80% off list prices. The company will also participate in the TrumpRx.gov direct purchasing platform and invest approximately $50 billion in U.S. medicines manufacturing and R&D. The agreement will exempt AstraZeneca from Section 232 tariffs for three years, during which AstraZeneca will fully onshore American medicines manufacturing. According to a White House fact sheet, in addition to discounts on direct-to-consumer medicines, every state’s Medicaid program in the country will have access to the “most favored nation” pricing on all AstraZeneca medicines. All new medicines introduced to the American market will be made available at similarly discounted rates. “Every year AstraZeneca treats millions of Americans living with cancer and chronic diseases and, as a result of today’s agreement, many patients will access life-changing medicines at lower prices,” said Pascal Soriot, CEO, AstraZeneca, in the release. “This new approach also helps safeguard America’s pioneering role as a global powerhouse in innovation and developing the next generation of medicines. It is now essential other wealthy countries step up their contribution to fund innovation.” “Today, AstraZeneca is committing to offer all of their prescriptions to Medicaid at Most Favored Nation prices,” said President Trump during a White House announcement. “In other words, the lowest price anywhere in the world, that’s what we get. A move that will save American taxpayers hundreds of millions of dollars each year.” NEWS
HAS - CERBIOS Inside HAS-Cerbios: Building a unique CDMO Denis Angioletti, Group Head of Commercial & Business Development, framed it in commercial terms. “We can see that we are adding value to what each company was,” he said. “Some customers are now complementing or using what the other company is bringing on board.” Aligning to a fast-growing sector The timing is certainly no accident. The outsourcing of pharmaceutical manufacturing is accelerating as drugs become more complex and costly to produce. Frost & Sullivan estimates the biologics CDMO market grew from $13.3bn in 2018 to $29.3bn in 2022, with projections to reach $100.4bn by 2030. A separate Frost study valued the sector at $21.09bn in 2023 and forecast it would hit $68.97bn by 2031, a compound annual growth rate above 16%. The broader picture is just as striking with Bourne Partners estimating that the global CDMO market will reach around $200bn by 2025, with mid- to highsingle-digit annual growth thereafter. The financial services firm stresses that the top five players hold less than 15% of the market, highlighting its fragmentation and the opportunity for specialists. A new chapter begins in Switzerland’s pharmaceutical services landscape as HAS Healthcare Advanced Synthesis and Cerbios-Pharma join forces under the HAS Group banner, creating a unified front in the CDMO market. Finalised in May of this year, the HAS Group is now in the process of introducing itself into the hearts and minds of its clients, where CPHI presents an opportune moment to familiarize the wider market with the HAS Group identity. The new combined contract development and manufacturing organization (CDMO) will compete globally in oncology, high-potency active pharmaceutical ingredients (HPAPIs), and antibodydrug conjugates (ADCs). For Waldo Mossi, CEO of HAS Group, the deal is about more than scale. “This acquisition is a transformative step,” he told 24/7 BIOPHARMA. “We started the integration phase by creating an executive committee with key management figures from both organizations.” That structure, he explained, allows teams to align across research, production, finance, and business development from day one. 24CPHI FRANKFURT 2025 PREVIEW
HAS - CERBIOS scientific passion, respect for the client, respect for the people, is very similar between the two companies,” Angioletti said. Speed of execution is another priority. “We are now stronger and bigger, but we still maintain speed in decisionmaking and execution,” he noted. “A client recently highlighted very strongly that speed is essential to them.” Mossi echoed the sentiment, calling Swiss quality and agility “our signature worldwide.” Investing for growth To support its strategy, the group is committing significant funds. “From a technological point of view, we are investing around CHF20m (€21.4m) combined only in 2025, and other investment will follow in the five-year plan,” Mossi said. According to Angioletti, the spending reflects clear priorities: “We are expanding our R&D lab, building a second line for conjugation, and preparing for a third, expanding capacity for oncology, and expanding the R&D team for high potency in general. That’s exactly reflecting what the market is asking for.” The expansion includes strengthening quality control infrastructure, scaling manufacturing space, and upgrading industrial capabilities to ensure resilience as demand grows. That fragmentation is critical as, unlike markets dominated by a handful of giants, CDMOs remain diverse, with regional champions and niche players competing alongside multinational groups. For Mossi, this creates room for differentiated offerings. “HAS is representing a very robust scientific chemical and regulatory know-how for APIs, highly potent and anti-cancer,” he said. “Cerbios is a very solid chemical and biotechnological company. Together, the two companies represent something very unique.” Betting on ADCs Among the fastest-growing opportunities in oncology are ADCs, therapies that deliver toxic payloads directly to cancer cells via targeted antibodies. Developing them requires both advanced biotechnologies and high-potency chemistry, a rare combination. “The combination of chemical know-how and biotechnological know-how will reinforce our capacity to develop and manufacture ADC molecules,” Mossi said. In a similar vein, Angioletti added that clients are already responding: “We now have a complete set of manufacturing lines, development lines, and expertise in high potency oncology and ADCs.” The group intends to expand its ADC capabilities under the Proveo brand, which Cerbios launched with partners in 2015 to integrate conjugation, payload, and linker chemistry and fill finished. Vision and integration To support integration, the companies introduced cross-functional teams, newsletters, and staff surveys aimed at ensuring employees remain engaged and part of the new organization. “People are the basis of what we do,” Angioletti said. “They still feel part of the family, even with the changes, which is essential.” Mossi said the long-term ambition is clear. “The vision is to become a Swiss centre of excellence serving the pharmaceutical world in the CDMO sector with strong expertise in scientific content technologies and industrial sustainability.” Balancing scale with agility In an industry where projects can span a decade, both leaders stressed that customer trust and cultural alignment are vital. “Quality, Waldo Mossi, CEO of HAS Group & Denis Angioletti, Group Head of Commercial & Business Development. 25 CPHI FRANKFURT 2025 PREVIEW
to win business from both emerging biotech firms and large pharma clients seeking partners with specialized skills. “The group is a well-established player in this CDMO field,” Angioletti said. “It’s a company with strong roots in respect, transparency, service, and speed of execution. We have a long vision, up to five and ten years, and have plans for investments in that direction.” For Mossi, the goal remains straightforward: “A Swiss centre of excellence serving the pharmaceutical world of CDMO. That’s our target for the coming years.” As Angioletti put it: “When you see clients returning time and again, it means you are doing something right.” HAS and Cerbios will be present at CPHI Frankfurt from October 28–30, where it will highlight the group’s expanded capabilities following the merger. Executives will be available to meet clients and partners at booths 9.1D77 and 9.1F77. By sequencing investments step by step, the group aims to remain flexible while avoiding overextension. Risks and discipline The CDMO sector’s strong growth also brings a unique set of challenges. Facilities for biologics and ADCs require vast capital outlays and lengthy regulatory approvals. If demand falters, underutilized assets can quickly erode margins. HAS and Cerbios believe their focused approach mitigates this risk. “Specifically for ADCs, there are many investments ongoing and others planned to increase our capacity in terms of linker payload and conjugation,” Mossi said. “We want to become a leader in ADC development and manufacturing.” Angioletti stressed prudence: “We are not one of those companies shooting out investment and doing things. We do tailor-made what is necessary, step by step, but in advance, in order to keep the speed and the capacity in our services.” Looking ahead This union positions HAS and Cerbios to capture opportunities in a sector expected to double in size within the decade. By combining chemistry, biologics, and regulatory expertise, the group aims HAS - CERBIOS WILL CHU Editorial team 24/7 BIOPHARMA 26CPHI FRANKFURT 2025 PREVIEW
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