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1 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2025 Navigating the future: WELCOME ELLIE BRUNI Publishing Director TWENTYFOURSEVENBIOPHARMA As we gather at DCAT Week, the biopharma industry finds itself at a pivotal juncture. The rapid acceleration of innovation, paired with shifting geopolitical dynamics, is shaping not only our strategies but also the very fabric of patient care and drug development. Emerging trends: innovation meets adaptation The biopharmaceutical sector has witnessed groundbreaking advancements, particularly in areas such as gene therapy, personalized medicine, and artificial intelligence in drug discovery. These innovations are not just enhancing how we develop therapies but are also addressing significant unmet medical needs. The integration of real-world data into the drug development process is proving invaluable, enabling us to better understand patient outcomes and optimize treatment pathways. However, as we embrace these innovations, we must also remain vigilant to the trends shaping our industry. The post-COVID landscape is characterized by a renewed focus on supply chain resilience and regulatory agility. The lessons learned during the pandemic have driven us to rethink our operational strategies to ensure continuity in product availability, ultimately placing patient safety at the forefront. Geopolitical influences: a global perspective As we navigate these advancements, it is imperative to consider the geopolitical factors at play. The shifting alliances and trade policies worldwide have significant implications for biopharma. Access to markets, collaboration on research, and regulatory compliance are increasingly influenced by geopolitical relations. The need for a collaborative global approach has never been more critical. The biopharma community must advocate for policies that encourage international cooperation to foster innovation and improve global health outcomes. Additionally, the rise of biopharma hubs in emerging markets presents both opportunities and challenges. These regions are becoming key players in drug development and manufacturing, offering cost efficiencies and access to diverse patient populations. However, we must also address the regulatory complexities and ensure that equitable access to therapies is prioritized. Looking ahead: collaboration and ethical responsibility As we convene at DCAT Week, let us remember that the future of biopharma lies in collaboration. Cross-industry partnerships, academia, and public health organizations must work together to harness the full potential of our innovations. Ethical considerations should guide our pursuit of excellence, ensuring that we prioritize patientcentric approaches in every aspect of our work. In conclusion, as we reflect on our progress and look toward the future, let us focus on fostering resilience in our industry. Embracing innovation, navigating geopolitical challenges, and prioritizing collaboration will be essential to driving transformative change in biopharma. Together, we can ensure that our advancements lead to better health outcomes for patients globally. We look forward to engaging discussions and shared insights during this pivotal week. Publishing Director: Ellie Bruni | +44 (0) 7872 516194 ellie.bruni@247biopharma.com Advertising: info@247biopharma.com Editorial contact: Please send your news and suggestions for feature articles to the editorial team at editor@247biopharma.com TWENTYFOURSEVENBIOPHARMA is published by BIBO Publishing SL, Av. Diagonal, 409, 1St Floor, 08008, Barcelona, Spain. Disclaimer: The disclaimer has an error: BIBO Publishing SL will not be held responsible or liable for errors or omissions supplied or contained in this publication, although due care and attention are taken to ensure all content is accurate at the time of going to press. BIBO Publishing SL also will not be held responsible for any false claims made by advertisers, or in articles contributed by external authors. Copyright: The contents of this publication are copyright © BIBO Publishing SL 2024. No part of this publication can be reproduced or transmitted in any form without the express permission of the publisher. ISSN 2516-4481
2 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2025 BIOTECH STARTUPS 26 From lab to market: Biotech startups leading the new wave of innovation INDENA 34 Indena’s distinctiviness in CDMO services STERLING PHARMA SOLUTIONS 38 The use of economically beneficial ammonia chillers to improve sustainability in pharmaceutical manufacturing ARAGEN 46 Unpacking global biopharma business relations with Ashu Tandon KENNETH DREW Vice President Flamma USA 42 INTERVIEW CONTENTS 1 WELCOME NEWS 4 MARGA VIÑES Associate Director Contract Manufacturing & IV Solutions Grifols International 30 INTERVIEW DCAT SUMMIT 22 Upcoming DCAT European conference Expedition Pharma: Innovation from a patient-first perspective PROCOS 24 Fostering collaboration and empowerment
3 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2025 WOMEN IN SCIENCE 52 Paving the way for success ONESOURCE 54 Discussing drug-device combinations with Onesource’s Neeraj Sharma CPHI REPORT 56 CPHI Annual Report re-analysed: All bets off in Trump’s final term? Not for me BCG-IPSO REPORT 62 India’s CRDMO sector growth potential at $22 - $25 Billion by 2035, driving global pharma innovation CONTENTS CHIARA BAROZZI Analytical Validation & Services Manager Cerbios-Pharma SA 50 WOMEN IN SCIENCE ROSA MARIA MORENO Chief Operations Officer JOAN FEIXAS Chief Executive Officer LAURA GRAU Chief Commercial Officer Enantia 48 INTERVIEW from page 65
4 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2025 NEWS Axplora, a global leader in API small molecule and ADC (antibodydrug conjugate) manufacturing, is strengthening its leading position in the commercial manufacturing of ADCs with the launch of a cutting-edge payload manufacturing workshop at its Le Mans site (France). This expansion, which is part of the France 2030 program, builds on Axplora’s proven commercial track record, supplying 40% of the world’s marketed ADCs, and 50% of FDAapproved ADCs. The new state-of-the-art facility reinforces Axplora’s commitment to deliver high-quality clinical and commercial-scale solutions for ADC development and manufacturing. Axplora continues to partner with leading innovative pharmaceutical companies developing the next generation of targeted therapies in oncology, benefitting thousands of patients worldwide. Expanding commercial payload manufacturing capabilities Designed for maximum flexibility and efficiency, the new GMP workshop is currently equipped with three Hastelloy reactors, and can accommodate a fourth, offering a production range of 30 to 200 litres. Additionally, a dedicated Hastelloy filter dryer ensures high-level containment and safety, aligning with the highest industry standards for cytotoxic payload manufacturing. Producing batches up to 1.5 kg, this facility is engineered to support the rapidly growing demand for nextgeneration payload families that are driving innovation in oncology therapies such as Auristatins and Tecans. These expanded manufacturing capabilities will ensure Axplora can meet increasing customer needs for larger quantities, while guaranteeing secure and scalable supply. Comprehensive ADC solutions under one roof The expansion of Axplora’s Le Mans facility cements its role as a fully integrated partner for ADC development and manufacturing. It features six dedicated ADC workshops, broadly split across two for clinical payload-linker production, two for commercial payloads, and two for bioconjugation. This integrated approach streamlines project management, enabling Axplora to support ADC development at every stage and smoothly scale up production to commercial supply. Backed by over 20 years of expertise in cGMP ADC development and manufacturing, and with more than 250 cGMP batches produced, the Le Mans site is also home to four purification lines ranging from small to large scale. These lines leverage high-performance chromatography, a gold-standard technology for producing efficient, high-quality cytotoxics. Clients also benefit from Axplora’s bestin-class payloadlinker development laboratories, bioconjugation suites and drug product release testing, enabling seamless transition from early clinical phases to commercial production—all with a single team of experts guiding the process to de-risk supply chains. This integrated approach enables Axplora to expedite its customers’ ADC program’s timelines, reduce complexity, and ensure the delivery of high-quality ADCs. Clients benefit from unmatched expertise, seamless scalability, and the reliability of working with a single, specialized, leading CDMO partner. Supporting innovation and growth in ADC development “This expansion is a bold step forward in our mission to support clients at every stage of ADC development and manufacturing,” stated Arul Ramadurai, Chief Commercial Officer. “By combining state-of-the-art payload manufacturing with our proven expertise in purification and bioconjugation, we’re enabling pharmaceutical innovators to accelerate drug development and deliver transformative treatments to patients faster.” “With this investment, Axplora is strengthening its position as a global leader in the development and manufacturing of antibody-drug conjugates,” said Rachel de Luca, Site Director, Le Mans. “The addition of this new payload manufacturing asset demonstrates our dedication to equipping clients with the cuttingedge tools and capabilities needed to develop the next generation of lifesaving therapies.” Axplora expands commercial payload production capabilities at Le Mans to strengthen its leading position in ADC Manufacturing
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6 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2025 NEWS After receiving approvals from the Italian Ministry of Health and AIFA in 2021, Indena reaches another major milestone for its pharmaceuticalgrade cannabidiol Indena achieves another milestone: it’s the first global API manufacturer with European CEP certification for its CBD extract, which the company produces for clinical and commercial use. The European Pharmacopoeia Certificate of Eligibility (CEP) is a document issued by the European Directorate for the Quality of Medicines (EDQM). It certifies the compliance of an active substance with the quality and safety specifications established by the European Pharmacopoeia. This CEP certification underscores the high quality of Indena’s CBD and the company’s commitment to meeting the needs of customers worldwide seeking a quality- and safety- certified ingredient. Furthermore, Indena stands alone globally, as the only API manufacturer to have received this certification. Indena previously received two key authorizations in 2021. The Italian Ministry of Health granted permission for the manufacture of cannabinoid-based cannabis extracts, while AIFA authorized the production of cannabidiol (CBD) for pharmaceutical use. Indena’s CBD is derived from the flowers and aerial parts of Cannabis sativa L. through extraction and isolation. The raw material is grown and processed in Italy. The company controls, certifies, and fully traces the supply chain, ensuring compliance with stringent Italian regulations. Indena’s rigorous management of the production chain was instrumental in securing authorizations from both Italian and European authorities. Indena uses registered varieties of hemp with a THC level of less than 0.2% in accordance with European standards. It also guarantees a residual THC content of less than 0.02%, well below the limits defined by the FDA (Food and Drug Administration) and by DEA (Drug Enforcement Administration). This approach enabled Indena to promptly submit the DMF (Drug Master File) for this product to the FDA. Cecilia Nastro, Regulatory Affairs Department, says: “This CEP certification represents a significant step forward for Indena. The extensive analytical work undertaken by our team, who meticulously examined our API and processes to meet the demanding standards of this European certification, demonstrates our commitment to delivering high-quality, reliable pharmaceutical ingredients. This achievement positions us well to meet the growing global demand for rigorously certified CBD products”. Indena processes its hemp biomass in a pharmaceutical-grade facility authorized by AIFA and inspected by leading international regulatory agencies, including the FDA, KFDA, and PMDA. All production adheres to pharmaceutical Good Manufacturing Practices (GMP), reflecting Indena’s longstanding commitment to the highest quality standards, recognized by the international scientific community. Cannabidiol (CBD) is an active pharmaceutical ingredient used in products approved for treating seizures associated with rare childhood epilepsy syndromes, including Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. CBD is also undergoing clinical development for other forms of epilepsy and is being studied for its therapeutic potential in schizophrenia, other psychiatric disorders, neurological diseases, and autoimmune/inflammatory conditions1. Reference 1. C. Michael White, PharmD, A Review of Human Studies Assessing Cannabidiol’s (CBD) Therapeutic Actions and Potential, J Clin Pharmacol 2019, 59(7), 923-934. Indena first globally to secure European CEP for CBD Axplora, a global leader in API small molecule and ADC manufacturing, is proud to announce a landmark €50 million investment in its Mourenx site in Southwest France, securing its position as a key player in the fight against cardiovascular and metabolic diseases. Specializing in large-scale API industrial chemistry and chromatography, this transformative project will enhance Mourenx’s capabilities, positioning Axplora announces €50 Million Investment in GLP-1 Manufacturing at Mourenx (France) Site
7 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2025 it as a center of excellence in the Axplora network for contract manufacturing of APIs and drug substances for FDA-approved biologics. This investment demonstrates Axplora’s dedication to partnering with leading pharmaceutical companies, fostering innovation, supporting local economic growth, and delivering life-changing therapies to patients worldwide. By upgrading Mourenx’s infrastructure and capabilities, Axplora will solidify its position in peptide purification in a biologics environment and support the development of next-generation therapies, including GLP-1 drugs that target diabetes and obesity— some of society’s most urgent health challenges. “GLP-1 therapies represent a paradigm shift in medicine, offering targeted therapies for complex diseases with unprecedented efficacy and tolerability,” said Arul Ramadurai, Chief Commercial Officer. “This initiative, built on strong customer partnerships, reinforces Axplora’s role as a trusted partner in manufacturing lifechanging, breakthrough medicines.” “This project is testament to our pioneering expertise in industrial chromatography, and working closely with our client, we target having the facility BLA-ready in 15 months. To achieve this our internal teams are working closely with partners in a strong crossfunctional project team, wellsupported by the local authorities. We are looking forward to a bright future at Mourenx,” stated Dr. Pere Patón-Morales, Chief Operating Officer. Construction and infrastructure development will begin immediately, with first supplies of GLP-1 therapies expected in 2026. This investment ensures the Mourenx site will remain a key contributor to Axplora’s API network well into the 2030s and beyond. Cerbios-Pharma is proud to announce the opening of a new expansion area at the Lugano site for clinical and commercial manufacturing of Highly Potent Active Pharmaceutical Ingredients (HPAPIs), including cytotoxic linker payloads for antibodydrug conjugates (ADCs). The inauguration was conducted in the presence of Christian Suà, CEO of Cerbios-Pharma, and the members of Cerbios team whose expertise and commitment made this expansion possible. The manufacturing unit is equipped with isolator containment technology for highly potent molecules down to an OEL <10 ng/m3. This advanced facility ensures maximum flexibility to accommodate a wide range of molecule types. With the investment, Cerbios offers expanded capacity for state-of-the-art purification technologies such as high and low pressure chromatography, nanofiltration and freezedrying The new area is located within the latest constructed facility which was approved by Swissmedic in 2023, providing an immediate additional capacity to serve the increasing market demand for this product category. This milestone reinforces Cerbios-Pharma’s strategic investment in high-potency manufacturing and strengthens its position as a leading CMO in the commercial supply of HPAPIs and ADCs. Cerbios-Pharma S.A. boosts production capabilities for HPAPIs and ADCs NEWS
8 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2025 NEWS Following its 16 July 2024 announcement, CordenPharma is pleased to share significant progress on its growth initiatives with a >€1 billion strategic investment in peptide development and manufacturing. The company’s ambitious expansion plans are set to propel its Peptide Platform business beyond the €1 billion sales milestone by 2028, reinforcing CordenPharma’s position as a market leader in integrated supply of small to large-scale services from APIs to Drug Products, for both Injectable and Oral Peptides. As part of this strategy, CordenPharma has finalized plans to establish a stateof-the-art peptide manufacturing facility in Switzerland located at Getec Park in Muttenz, just 8 km outside Basel – a major biotech and pharma hub within Europe. The decision to locate the plant near Basel is supported by several key advantages, including: - Efficient infrastructure, with existing systems for handling materials and processes that are crucial for state-of-the-art peptide manufacturing. - Optimal logistics, with streamlined access to transportation networks. - Established large-scale utilities already in place to support chemical manufacturing needs. - Talent pool access due to close proximity to Basel, a renowned pharma and biotech hub at the crossroads of Germany, France, and Switzerland, ensuring access to highly skilled professionals. - The surrounding industrial park ensures sustainable operational efficiency in a well-established manufacturing ecosystem with closed-loop energy and material cycles, as well as innovative wasteto-value streams, with a clear strategic path to net-zero. This >€500 million investment will feature multiple manufacturing lines capable of supporting small, medium, and large-scale peptide production with small- to large-scale Solid Phase Peptide Synthesis (SPPS) reactors for GLP-1 and non-GLP-1 peptide projects – with a total SPPS reactor capacity of more than 5,000 L. The new state-of-the-art facility will feature advanced automation, cuttingedge digitalization, and innovative peptide production technologies, ensuring compliance with the most stringent regulations, including BLA requirements. With the main construction and qualification phase taking place between 2025 and 2027 and start of commercial activities to begin in the first half of 2028, the company is proud to generate over 300 new jobs, contributing to economic growth and innovation of the region. In their Boulder, Colorado US facility, both expansions to existing lines and the construction of a new greenfield production area have already begun in parallel to the Switzerland initiative. The expansion will more than double the existing SPPS reactor capacity at CordenPharma Colorado by adding an additional 25,000 L of SPPS capacity – making it a total reactor capacity of >42,000 L by 2028. Once fully operational, the Switzerland site - together with the ongoing expansions and additional greenfield capacity at CordenPharma Colorado - will significantly enhance the company’s production capabilities, solidifying CordenPharma’s position as one of the largest peptide manufacturing partners leading the CDMO peptide space. Dr. Michael Quirmbach, President & CEO of CordenPharma Group comments: “We are excited to announce the construction of a state-of-the-art manufacturing plant just outside Basel, Switzerland, within one of the leading pharma and biotech hubs in Europe. The new facility is designed to deliver flexible and efficient peptide manufacturing to meet the growing demand of innovative peptide medicines for our customers and ultimately, patients.” Judith Charpentier, Co-Head Flagship Fund and Head of Healthcare at Astorg comments: “CordenPharma’s bold expansion reflects its leadership in addressing the growing demand for peptide manufacturing. As a long-term investor, we are fully committed to supporting this growth, combining industrial excellence with strategic investment to strengthen CordenPharma’s position as a leading global CDMO. Ultimately, this expansion contributes to expanding access to those life-saving peptide-based medicines for patients.” CordenPharma was acquired by Astorg, a leading Pan-European private equity firm, in 2022 to accelerate its development plans. With Astorg’s backing and these expansions, CordenPharma is well-positioned to execute its growth strategy and further strengthen its leadership in the CDMO peptide space. CordenPharma expands peptide platform with >€500m Greenfield facility construction in the Basel region of Switzerland
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10 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2025 NEWS Eli Lilly and Company announced at a press conference in Washington, D.C., plans to bolster its domestic medicine production across therapeutic areas by building four new pharmaceutical manufacturing sites in the United States. This brings the company’s total U.S. capital expansion commitments to more than $50 billion since 2020. Three of the future U.S. sites announced today will focus on manufacturing active pharmaceutical ingredients (API), reshoring critical capabilities of small molecule chemical synthesis and further strengthening Lilly’s supply chain. The fourth location will extend the company’s global parenteral manufacturing network for future injectable therapies. “Lilly’s optimism about the potential of our pipeline across therapeutic areas – cardiometabolic health, oncology, immunology and neuroscience – drives our unprecedented commitment to our domestic manufacturing build-out. Our confidence positions us to help reinvigorate domestic manufacturing, which will benefit hard-working American families and increase exports of medicines made in the U.S.A.,” said David A. Ricks, Lilly chair and CEO. “This bold move reflects our commitment to stay ahead of anticipated demand for safe, high-quality, FDA-approved medicines of the future.” At these four new sites, Lilly expects to create more than 3,000 jobs for highly skilled workers, including engineers, scientists, operations personnel and lab technicians. Additionally, the company anticipates that it could create nearly 10,000 construction jobs during the development of the sites. “To deliver on our big bets on next-generation modalities like small molecules, biologics and nucleic acid therapies, Lilly is investing in the state-of-the-art manufacturing infrastructure needed to deliver tomorrow’s safe and reliable medicines,” said Edgardo Hernandez, executive vice president and president of Lilly Manufacturing Operations. “We are not just building facilities. We are creating a future where American innovation leads the world in pharmaceutical manufacturing, requiring a highly skilled workforce prepared to shape the future of health care. This is a significant step for our company, our communities and the patients we serve.” Expected additional economic benefits of these new sites to the selected communities include increased local spending, tax revenue, economic diversification, improved infrastructure, population growth, and training and development opportunities. Ricks added, “The Tax Cuts and Jobs Act legislation passed in 2017 during President Trump’s first term in office has been foundational to Lilly’s domestic manufacturing investments, and it is essential that these policies are extended this year. We believe that our investments in America and upskilling our nation’s workforce will spark a significant ripple effect. For every job we create, many more will be generated, positively impacting the communities that host our innovative new sites.” The company’s previous total domestic capital expansion commitments from 2020 to 2024 totaled $23 billion and represented in today’s $50 billion announcement, included: - New sites in Research Triangle Park and Concord, North Carolina - New sites at the LEAP Innovation District in Lebanon, Indiana - Expansions and updates to several different manufacturing facilities in Indianapolis - Development of the new Lilly Medicine Foundry in Lebanon, Indiana - Acquisition and expansion of Lilly’s manufacturing site in Kenosha County, Wisconsin Lilly plans to more than double U.S. manufacturing investment since 2020 exceeding $50 billion Thermo Fisher Scientific Inc., the world leader in serving science, today announced that the company has entered into a definitive agreement with Solventum to acquire Solventum’s Purification & Filtration business for approximately $4.1 billion in cash. Solventum’s Purification & Thermo Fisher Scientific to acquire Solventum’s purification and filtration business
11 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2025 NEWS Filtration business is a leading provider of purification and filtration technologies used in the production of biologics as well as in medical technologies and industrial applications. The Solventum business operates globally with sites across the Americas, Europe, the Middle East, Africa, and the AsiaPacific region, and has approximately 2,500 colleagues. In 2024, Solventum’s Purification & Filtration business generated approximately $1 billion of revenue. Solventum’s Purification & Filtration business is highly complementary to Thermo Fisher’s bioproduction business. Today, Thermo Fisher has a leading portfolio of offerings in cell culture media and single-use technologies. Solventum’s innovative filtration portfolio broadens Thermo Fisher’s capabilities in the development and manufacturing of biologics, spanning upstream and downstream workflows. “The addition of Solventum’s business is an outstanding strategic fit with our company and will create significant value for our customers and shareholders,” said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher. “Solventum’s portfolio of solutions will be valued by our customers, and further demonstrate our disciplined capital deployment strategy which has an excellent track record of creating shareholder value.” Casper continued, “As the trusted partner to our customers, Solventum’s Purification & Filtration business will expand and add differentiated capabilities to our bioprocessing portfolio to better serve our customers in this rapidly growing market. We look forward to welcoming our new colleagues to Thermo Fisher.” The transaction is expected to be completed by the end of 2025 and is subject to customary closing conditions and regulatory approvals. Once the transaction closes, Solventum’s Purification & Filtration business will become part of Thermo Fisher’s Life Sciences Solutions segment. Solventum’s Purification & Filtration, as part of Thermo Fisher, is expected to generate mid- to high-single digit organic growth and the application of the PPI Business System will enable strong margin expansion and meaningful synergy realization. In the first year of ownership, the transaction is expected to be dilutive to adjusted EPS1 by $0.06. Excluding financing costs, the transaction is expected to be accretive by $0.28 in that period. This reflects the very strong day one cost synergies when Solventum’s allocated segment costs are replaced by lower run rate costs within Thermo Fisher, partially offset in year one by one-time business stand up costs. Thermo Fisher expects to realize approximately $125 million of adjusted operating income from revenue and cost synergies by year five following the close. The expected long-term business growth, margin expansion opportunity and synergy realization make the financial returns on the transaction very compelling with a double-digit internal rate of return. Adjusted earnings per share and adjusted operating income are nonGAAP measures that exclude certain items detailed later in this press release under the heading “Use of Non-GAAP Financial Measures.”
NEWS SK pharmteco Cell & Gene Europe, a global contract development, manufacturing, and analytical testing organization serving the pharmaceutical and cell & gene therapy industries, along with Assistance Publique – Hôpitaux de Paris (AP-HP), and Institut Imagine (Inserm, AP-HP, Université Paris Cité) announced the signing of a contract for the production of a 200L CGMP clinical batch of lentiviral vector (LVV) and associated regulatory support. AFMTéléthon is the main funder of the final preclinical phases and the technical production of the clinical batches that have enabled us to reach this new milestone. This collaboration focuses on developing a gene therapy against sickle cell disease using an ex vivo hematopoietic stem and progenitor cell (HSPC) gene modification approach with LVV. This innovative approach is based on a newly designed vector by the laboratories of Annarita Miccio and Marina Cavazzana, Research Directors at Institut Imagine, and also on previous collaborative work with Mario Amendola at Généthon laboratory. The project leverages SK pharmteco’s LentiSure™ platform and transgene plasmid, with analytical testing conducted at its facility in France. It is a key milestone towards the start of a clinical trial supported and sponsored by AP-HP and the translation of Institut Imagine’s research to clinical stage. “We are thrilled to partner with AP-HP and Institut Imagine on this critical project,” said Patrick Mahieux, President of SK pharmteco Cell & Gene Europe. “The successful production of both the technical and clinical batches will be yet another demonstration of the power of our LentiSure™ platform and our commitment to advancing gene therapies for serious diseases like sickle cell disease.” “We are proud to support this key validation phase for this gene therapy drug candidate for sickle cell disease, a rare and extremely serious blood disorder that affects thousands of people in France and millions worldwide, and to enable the researchers we have supported for many years, thanks in particular to the Telethon, to take the final step towards treating these patients” said Laurence Tiennot-Herment, President of AFM-Téléthon. “This collaboration represents a significant step forward in our efforts to develop a safe and effective gene therapy for sickle cell disease,” said Dr Jean-Roch Fabreguettes, clinical researcher and coordinator of AP-HP’s MEARY center for cell and gene therapy and manufacturing of advanced therapy medicinal products. “We are confident that this partnership with SK pharmteco and Institut Imagine will bring us closer to improving patients’ lives.” “Institut Imagine is dedicated to translating cutting-edge research into innovative therapies,” added Pr Marina Cavazzana, Head of Research. “This partnership with SK pharmteco and APHP enables us to move our pre-clinical findings into the clinic, offering hope for patients with sickle cell disease.” Sickle cell disease, a genetic disease that affects red blood cells, is most often diagnosed at birth. The most frequent symptoms are anemia, increased infection susceptibility, and painful attacks affecting various organs. According to the World Health Organization, approximately five million people are living with sickle cell disease. It is a chronic disease for which there is currently no cure; this clinical trial, therefore, represents a major hope for patients affected by this disease. SK pharmteco Cell & Gene Europe, AP-HP, AFM-Téléthon and Institut Imagine announce collaboration for lentiviral vector production for an innovative sickle cell disease clinical trial
NEWS Ascend Advanced Therapies (Ascend), a gene to GMP advanced therapy development partner, today announced the appointment of John Chiminski and Karen Flynn as non-executive members of its Board of Directors. John will serve as Chair of the Board and EW Healthcare Partners has designated Karen to serve on the Company’s board as one of its representatives. Their leadership and deep industry expertise will be pivotal as Ascend builds its capabilities and positions itself for growth. John Chiminski brings more than three decades of leadership in healthcare and pharma services. He served as CEO of Catalent from 2009 to 2015, then as Chair and CEO from 2016 through 2022, and as Executive Chair until June 2023. Under his leadership, Catalent grew into a global Tier 1 CDMO, expanded its capabilities, and significantly increased its impact on the pharma and biotech development and manufacturing ecosystem. He currently serves as a board member for QuidelOrtho (QDEL) and is a Senior Advisor for Abingworth. “Ascend is at a pivotal moment in its growth, and I am excited to support the team as we build a world-class gene therapy CDMO,” said Chiminski. “With the right strategy, investment, and operational excellence, Ascend is well-positioned to be a leading partner in advanced therapies.” Karen Flynn brings more than three decades of commercial and operations experience to the board of Ascend. Most recently, she served as Interim President of BioModalities at Catalent. Preceding this role, Karen held positions as Chief Commercial Officer and President of Biologics at Catalent. Prior to her tenure at Catalent, she served as Senior Vice President and Chief Commercial Officer for West Pharmaceutical Services, also assuming the role of President of its Pharmaceutical Packaging Systems business. She currently serves on the boards of Quanterix Corporation (QTRX), Sotera Health Company (SHC), Stevanato Group, and Germfree Laboratories, a portfolio company of EW Healthcare Partners. “With the addition of ABL, Inc. in late 2024 and investment by EW Healthcare Partners, the Ascend network can support gene therapy, oncolytic, vaccine, immunotherapy, and government customers at all stages of development through to fill/finish,” said Flynn. “Process development, optimization, and forthcoming GMP QC capabilities in Munich, Germany are complemented by the GMP facilities in Alachua, Florida, and the company’s headquarters in Rockville, MD. This is a worldclass offering built to support customers long term.” “We are excited to welcome John and Karen to the board. John and Karen bring tremendous leadership, strategic expertise, and industry knowledge that will help shape the future here,” said Mike Stella, CEO of Ascend. “Their counsel and extensive experience will be instrumental as we continue to manufacture advanced therapies and aggressively scale up the capabilities of the Company.” Ascend specializes in high-quality, cost-effective gene therapy development and manufacturing. Following the partnership with EW healthcare Partners that contributed its portfolio company, ABL, Inc. in late 2024, Ascend offers expanded commercial manufacturing, process development, and analytical capabilities across multiple facilities in the U.S. and Europe. Ascend Advanced Therapies appoints John Chiminski as Chair & Karen Flynn as Independent Director
NEWS Eli Lilly announced a $27 billion investment to build four new manufacturing facilities across the U.S. over the next five years, responding to concerns raised by the President about tariffs. Pfizer CEO Albert Bourla indicated that his company is prepared to move its manufacturing operations to the U.S. if necessary, during his remarks at the 45th TD Cowen Annual Health Care Conference in Boston. In a discussion with analyst Steve Scala on Monday, Bourla noted that Pfizer operates 13 production plants in the U.S., likely making it the company with the largest manufacturing network. He highlighted several of these facilities as “mega sites” focusing on the production of antibodies and sterile injectables. Bourla explained that if potential tariffs arise, Pfizer can swiftly shift production from international sites to U.S. facilities as needed. His comments followed a recent meeting with President Trump and other pharmaceutical leaders, where optimism about potential regulatory changes under the new administration was dampened by Trump’s warning of tariffs on companies that manufacture overseas. The President also did not commit to reducing the pricing negotiation program outlined in the Inflation Reduction Act. Analysts at Jefferies have identified the uncertainty surrounding the President’s tariffs as a significant concern for the pharmaceutical industry. They noted that while large companies like Gilead, Amgen, and Vertex may withstand these pressures, smaller firms are likely to face challenges. Recently, Trump suggested implementing additional tariffs of up to 25% on imported pharmaceuticals, which could rise substantially over the next year. Earlier this year, he also announced tariffs on imports from Canada, Mexico, and China, citing an “extraordinary threat” without clear justification. Analysts have pointed out that the tariffs on China, in particular, are problematic for the biopharma sector as companies seek new drug candidates there. These tariffs, effective since March 4, have prompted Eli Lilly’s substantial investment in domestic manufacturing, which is expected to create around 3,000 new jobs for engineers and scientists, along with 10,000 construction opportunities. Pfizer ready to relocate manufacturing if Trump follows through on tariff threats
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16 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2025 NEWS The Noramco Group, an integrated North Americanbased API and drug product supply chain product and services provider, today announced a $25 million investment in its Halo Pharma facility in Whippany, New Jersey, to establish sterile injectable manufacturing capabilities, including ready-touse, syringe, cartridge, and vial filling. This expansion aims to address critical capacity shortages in the US injectable supply chain and meet the growing demand from pharmaceutical companies seeking reliable domestic sterile manufacturing partners. The investment includes the installation of a high-speed, state-of-the-art Groninger UFVN FlexFill syringe, cartridge, and vial filling line and a SKAN isolator to enhance production efficiency and regulatory compliance. The new capabilities will allow Halo Pharma to manufacture batches ranging from 5,000 to 250,000 units, with an annual production capacity exceeding 50 million units. The initial container systems will include 0.5 mL, 1 mL long, and 1 mL short syringes, along with 2R vials, all in readyto-fill formats. Container filling can be performed via peristaltic pump or vacuum. Additional syringe, cartridge, and vial options will be introduced based on demand. Meeting industry needs for sterile injectable manufacturing products and services With sterile injectables representing the fastest-growing segment of the pharmaceutical market, demand for commercial and clinical-scale capacity continues to outpace available supply. Many injectable products remain on the FDA’s drug shortage list, exacerbated by the surge in demand for biologics and by the critical needs of the U.S. hospital supply chain. The Noramco Group’s investment will provide branded and generic pharmaceutical companies with a North American-based solution for sterile injectable manufacturing, strengthening the domestic production of critical drugs and reinforcing supply chain security and reliability. “This investment is a significant step in our commitment to build on our position as one of the only fully integrated domestic supply options for our customers,” said Lee Karras, CEO of The Noramco Group. “We recognize the challenges facing the industry and are dedicated to providing solutions that address both immediate and long-term supply chain needs. We anticipate the new line to be qualified and operational within the next 12 months, ensuring we can support customers with the high-quality capacity they require. While this investment enhances our capabilities with contemporary technologies, with the addition of sterile manufacturing we remain committed to our already established and proven focus on manufacturing APIs, oral solid dose, and liquid dosage forms, which continue to be essential in meeting our customers’ needs.” Expanding capabilities while maintaining core expertise The Whippany facility, which was historically focused on manufacturing oral solid dose (OSD), semi-solid, and liquid formulations for the past 20 years, will undergo significant renovations to support the new sterile filling line while maintaining its primary production capabilities. The sterile line installation will be carried out over the remainder of 2025, with facility upgrades to meet EU Annex 1 compliance for European market access while maintaining rigorous U.S. quality standards. The new line strengthens the Noramco Group’s offerings, taking advantage of its already established custom API synthesis business, and supporting the production of new chemical entity (NCE) and generic low bioburden APIs for injectable finished products through its Purisys business unit in Athens, GA. Further investments in packaging automation are planned for 2026, ensuring continued advancements in manufacturing efficiency and quality. The Noramco Group invests $25 million in Halo Pharma’s Whippany facility to offer sterile injectable manufacturing
18 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2025 Adragos Pharma, a leading contract development and manufacturing organisation (CDMO), announced the completion of a €4 million project to install and commission an advanced, cGMP-compliant liquid filling line and accompanying cartoning machine at its facility in Leipzig, Germany. The new capabilities will offer nearly ten times the production capacity at the site, enabling the company to meet rising demand while maintaining the highest standards of quality, efficiency, and compliance. The new line has the capacity to fill up to 13 million bottles per annum in various formats to supply pharmaceutical, cosmetic, and healthcare supplement products. The installation project initially involved relocating two existing semi-solid commercial manufacturing lines at the site to new production areas, which have now been inspected and are fully operational. These lines provide flexible capabilities for the manufacturing and packaging of ointments, creams, and gels. “This new flexible production line marks a key milestone in the development of our Leipzig site, expanding its capabilities and reinforcing our dedication to delivering state-of-the-art manufacturing solutions to our customers,” said Florian Prell, Site Head of Adragos Leipzig. “Adragos is committed to growing and investing in innovation, and we are looking forward to the opportunities and client partnerships that this project will create, as we continue to lead the industry in high-quality liquid dose form manufacturing.” The 13,300-square metre facility in Leipzig was established in 1926 and specialises in manufacturing semi-solid and non-sterile liquid pharmaceuticals. Employing over 130 professionals, its services and expertise include galenical dose form development, pilot batch production through to commercial supply, advanced analytical method development, as well as worldwide raw material procurement and product quality assurance. Adragos Pharma completes the installation of a new liquid filling line in Leipzig, Germany Leading UK contract development and manufacturing organisation (CDMO) Upperton Pharma Solutions, has completed the build of its new sterile manufacturing facility in Nottingham, UK. The new facility is in addition to its existing 50,000 sq. ft facility, Trent Gateway, and the purposebuilt facility has been designed specifically in line with the revised EU GMP Annex-1 regulations. The 7,000 sq. ft facility will support the manufacturing of aseptic and terminally sterilised small volume liquids and powders for parenteral, nasal and pulmonary delivery. The new facility has the capability to support formulation development, clinical manufacture and analytical testing, with batch sizes of up to 2,000 vials, prefilled syringes and pre-filled cartridges for liquid formulations and pre-sterilized powders. The expansion is a natural progression for Upperton who already develop and manufacture small molecule and biological, non-sterile, oral, nasal and pulmonary dosage forms from early development to late-stage clinical manufacture for global NEWS Upperton completes build of new £7m sterile manufacturing facility
19 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2025 NEWS biotech and pharmaceutical companies. Nikki Whitfield, Chief Executive Officer, said, “We are delighted to complete the build of our sterile facility. The combined experience of our leadership team in sterile facility builds and subsequent operations ensures that we are ideally placed as a CDMO partner of choice for small to mid-sized biotech and pharma looking to get into the clinic quickly with fast access to sterile manufacturing services.” The sterile facility will feature two cleanrooms with advanced VHP isolation technology and carry out GMP manufacturing of sterile drug products making use of existing fullservice formulation development and quality control laboratories. Jon Austwick, Director of Quality & Compliance, said: “This expansion illustrates our continued investment in our capabilities to support drug developers to scale and accelerate the path to delivering safe and effective medicines to patients. The facility has been built with the highest level of quality and is a testament to our internal teams and build vendor who have worked tirelessly over the past 12 months to bring our vision to life”. This investment in sterile drug product manufacturing enhances the existing service offering from Upperton, which provides formulation development across a broad range of dosage forms, clinical trial supply, and late-stage manufacturing for non-sterile dosage forms for both small molecules and biologics. Whilst the commissioning of the facility, along with the installation and validation of new equipment continues, Upperton will utilise existing expertise within their research & development and analytical teams to support the pre-formulation and stability studies for early proof-of concept products for parenteral, nasal and pulmonary delivery. Icrom announced the grand opening of its brand new Research & Development laboratory, specifically designed for the advancement of Highly Potent Active Pharmaceutical Ingredients (HPAPIs). This stateof-the-art facility represents a significant enhancement of Icrom’s existing capabilities and underscores the company’s commitment to innovation in the pharmaceutical sector. Spanning an impressive 100 square meters, the new lab is equipped with advanced isolators that can handle compounds classified up to OEB 6, ensuring the highest safety standards and operational efficiency. Additionally, dedicated isolators for analytical activities have been included to bolster R&D efforts, facilitating comprehensive support for the development and optimization of complex synthesis processes. The laboratory is already operational, with ongoing plans to integrate additional analytical techniques that will further enhance Icrom’s ability to innovate and deliver top-quality pharmaceutical products. This milestone reflects Icrom’s unwavering dedication to advancing healthcare solutions, as the company continues to push the boundaries of what is possible in the field of highly potent compounds. Icrom unveils cutting-edge R&D laboratory for highly potent active pharmaceutical ingredients
20 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2025 NEWS Veranova is pleased to announce the move of its corporate headquarters to its Devens, Massachusetts facility, one of the company’s principal sites for manufacturing and development. Strategically located near the Boston pharmaceutical and biotech hub, Veranova’s Devens site is an FDA approved facility and a center of excellence for development through clinical and commercial manufacturing of antibody-drug conjugates (ADCs), high potent APIs, phosphoramidites and other complex small molecules. The site is currently undergoing a $30M expansion of its ADC and high potent development and manufacturing capabilities. The investment in Devens is part of a multi-year growth strategy to build the leading development and manufacturing partner for complex synthetic pharmaceuticals, and spans our locations in West Deptford, New Jersey; North Andover, Massachusetts; Edinburgh, Scotland and Cambridge, England. With the re-location of the corporate headquarters, Veranova will be exiting the current headquarters office in Wayne, Pennsylvania. Existing employees in Wayne will continue operating from a new location in Berwyn, Pennsylvania. Veranova relocates headquarters to Devens, MA SK pharmteco, a global contract development and manufacturing organization (CDMO), today announced the expansion of a core competency with the launch of an enhanced analytical testing laboratory specifically dedicated to High Potency Active Pharmaceutical Ingredients (HPAPIs). Located at SK pharmteco’s Rancho Cordova, California site, the stateof-the-art CGMP laboratory is a significant addition to the site’s current HPAPIs’ laboratory operations. Designed for the safe handling of potent chemicals for CGMP testing and release, the lab is now fully operational and has already achieved a significant milestone: the successful release of its first Active Pharmaceutical Ingredient (API). “We are excited to expand our capabilities and provide more efficient testing solutions for our customers,” said Joerg Ahlgrimm, CEO of SK pharmteco. “This expansion underscores our steadfast commitment to safety, innovation, and providing a seamless and customer-centric experience, particularly as compounds under development become increasingly more potent.” The new laboratory builds on the site’s current HPAPI capabilities and provides an increase in a controlled environment for the Quality Control and Analytical Method Development teams to handle highly potent and cytotoxic compounds. In addition to supporting the organization’s small molecule production programs, the laboratory is also available for contract analytical testing services. The laboratory’s notable features include: • Advanced Testing Capabilities: - Equipped to handle Highly Potent Compounds with Occupational Exposure Limits (OEL) to Band 5 - Analytical Weighing - Coulometric & Volumetric Water Titration - UPLC with Diode Array Detection - Headspace & Direct Inject Gas Chromatography with FID Detection • Stringent Containment & Safety Features: - Isolator Glove Box with inertion, washdown, & sample transfer capabilities - Exposure Control down to 0.008 µg/m3 TWA (qualified via independent third-party surrogate testing) - Dedicated HVAC maintaining negative pressure to the antechamber - Sample passthrough port for laboratory isolation - Dedicated gowning & degowning rooms with misting wash down decontamination With decades of experience in scaling HPAPI processes from clinical to commercial production, SK pharmteco brings unmatched expertise and capacity to support customers at every stage of development and reinforces its position as a trusted partner in the pharmaceutical industry, enabling the development and manufacture of lifechanging medicines. SK pharmteco launches state-of-the-art HPAPI laboratory
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