2 TWENTYFOURSEVENBIOPHARMA Issue 2 / June 2025
1 TWENTYFOURSEVENBIOPHARMA Issue 2 / June 2025 WELCOME ELLIE BRUNI Publishing Director TWENTYFOURSEVENBIOPHARMA Biopharma is an industry where time appears to operate only in extremes. Drug development is a years, if not decades-long process, and regulatory structures are debated and revised extensively before implementation. And yet, each year the pace of new technologies, practices, and innovations entering the market seems like it is only accelerating. This paradox is felt strongest at conferences. The past few months have been spent sprinting from DCAT to CPHI to BIO, giving the gifts of sore feet and (more importantly) the opportunity to interact with hundreds of members of the industry. The individuals have in turn presented 24/7 Biopharma with thousands of ideas about the past, present, and (most importantly) future of the industry. Every year these ideas coalesce around a few key topics. AI integration, patient-centricity, and GLP-1s are some of the most popular at this current inflection point. At times, it can feel like we spend too much time focusing on these select ideas, as if we’re fixated on them. But companies do innovate within these relatively broad buckets, and hardly a day goes by at a conference without encountering a genuinely innovative idea. Over the years, many of these bold ideas have not only taken shape, but seen widespread use and acceptance within the industry at large. And yet, within these gatherings of new and exciting ideas, a focus on partnerships is always present. No company exists in a vacuum, and no business model exists without clients. Consequently, not only is there not a day that passes without the topic coming up, there’s hardly a conversation that happens without it being mentioned at least in passing. The collective focus serves not only as a continual reminder for us to keep our own partners in mind, but also the contradictory nature of biopharma. Because while some things move fast, and others progress glacially, partnership is one of the increasingly few constants. 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 2 / June 2025 GLATT PHARMACEUTICAL SERVICES 44 Non-negotiable imperatives for pharma production ALFASIGMA 46 Meeting Morpho, Alfasigma’s CDMO AGC PHARMA CHEMICALS 48 The critical role of a resilient and flexible supply chain SHILPA PHARMA LIFESCIENCES 50 Shilpa launches hybrid CDMO at DCAT THERMO FISHER 52 Thermo Fisher’s Accelerator™ Drug Development and the future of biopharma innovation AVENACY 54 Innovating in specialty pharma: Jeffrey Yordon on Avenacy’s strategy for market differentiation and growth CONTENTS 1 WELCOME NEWS 4 BIO INTERNATIONAL CONVENTION 22 BIO 2025: The roundtable BIOTECH 28 Powering the pipeline: The technologies and deals rewriting biotech’s playbook REGULATION 32 Reform or regulatory overreach? The mixed legacy of Trump’s FDA reforms WOMEN IN SCIENCE 36 JAYASHREE AIYA Chief Scientific Officer Syngene ARTIFICIAL INTELLIGENCE 40 From data to discovery: How AI is transforming the drug pipeline
3 TWENTYFOURSEVENBIOPHARMA Issue 2 / June 2025 CONTENTS
4 TWENTYFOURSEVENBIOPHARMA Issue 2 / June 2025 NEWS Ingenza is delighted to announce its relocation to The Moubray Building at Edinburgh Technopole, part of the Pioneer Group. The new site is still within the Midlothian Science Zone – a world-leading centre of research excellence in life sciences – and is now fully operational, marking a significant milestone in the company’s continued growth. Ingenza is a technology-driven contract research, development and manufacturing organisation (CRDMO) that specialises in biologics, small molecule pharmaceuticals and sustainably manufactured industrial products. This move follows a strategic review of the company’s longterm development plans, and the bespoke, state-of-the-art, multimillion-pound Moubray Building is designed to more than double Ingenza’s operational footprint. The expansion will significantly increase capacity across all service areas, strengthening the company’s ability to deliver flexible, scalable solutions to its growing customer base. The innovative design will allow Ingenza to scale up manufacturing to 100L, paving the way for the production of first-in-human materials. Jaymin Amin, Chief Business Officer of Ingenza, commented: “This is a landmark investment for Ingenza. It will enable us to significantly increase our operational scale, further expand our research and development laboratories, and enhance our bespoke service offerings to better support the growth of our customers. Central to this expansion is our inGenius® platform technology, which is revolutionising drug substance development for investigational new drug (IND)- enabling studies. This exciting move is not only about gaining physical space; it will also act as a catalyst to accelerate innovation and reinforce our position as a trusted partner in bioprocess development for complex drug substances.” Ingenza’s CEO Ian Fotheringham added: “Our increased automation and computational biology capabilities at Moubray will turbocharge the expansion of our data-driven codABLE® gene design. Having already enhanced predictability, development speed and performance of protein production in E.coli and Bacillus spp., we now anticipate that codABLE® machine learning will shave weeks or even months off the timeline for delivery of optimised recombinant Pichia pastoris and CHO manufacturing hosts.” John Mackenzie, Director for Scotland at Pioneer Group, said: “Ingenza’s growth is hugely positive for our local life sciences cluster. It is an exemplar of the Pioneer model of local economic development and partnership to accelerate scientific discovery.” Ingenza announces move to purpose-built facility at Edinburgh Technopole The senior leadership team at Ingenza (top) and Ingenza’s new laboratories in The Moubray Building (bottom).
6 TWENTYFOURSEVENBIOPHARMA Issue 2 / June 2025 NEWS Ethris, a clinical-stage biotechnology company pioneering next-generation RNA therapeutics and vaccines, and Lonza, one of the world’s largest contract development and manufacturing organizations (CDMOs), announced a collaboration to develop roomtemperature stable, spray-dried formulations of mRNA-based vaccine candidates, designed for mucosal delivery that offer a promising approach to combat respiratory diseases. Room-temperature stability aims to address significant supply chain challenges associated with some mRNA vaccines, including the dependence on ultra-lowtemperature storage and complex delivery systems. Overcoming these challenges will simplify production, reduce costs, and support rapid, scalable vaccine development. In addition, spray-dried formulations of mRNA-based vaccine candidates aims to enable needle-free nasal administration, potentially achieving mucosal immunity. The initial focus of the collaboration is to develop a first-in-class mRNA vaccine candidate against influenza delivered nasally. This non-invasive approach is designed to provide localized immune responses with an immune effect comparable to intramuscular vaccines and could reduce virus transmission by generating mucosal immunity at the site of virus entry. Under the terms of the agreement, Lonza will provide spray-drying and particle engineering for vaccine candidates based on Ethris’ stabilized non-immunogenic mRNA (SNIM® RNA) and stabilized lipid nanoparticles (SNaP LNP) platform at its Bend (US) site, which specializes in addressing bioavailability challenges and modulating pharmacokinetics to meet target product profiles. Lonza’s development expertise enables access to ideal properties for delivery to the respiratory tract alongside physical stability, while preserving the activity of the mRNA encapsulated within an LNP. Dr. Carsten Rudolph, Chief Executive Officer, Ethris, commented: “Lonza’s support and leading expertise is an asset and provides unique support as we progress development of our mRNA vaccine technology under the CEPI grant. Together, I believe we are well positioned to create promising noninvasive mucosal vaccine candidates that could potentially transform how respiratory diseases are prevented globally.” Jan Vertommen, Vice President, Head of Commercial Development, Advanced Synthesis, Lonza, added: “Spraydrying represents a well-established technique that addresses solubility and other manufacturing and stability challenges. However, its application in the field of DNA and RNA-based products represents a highly innovative approach, with another level of complexity introduced by the presence of LNPs. Combining the expertise of Lonza Bend site’s particle engineering team with the innovative SNIM® RNA of Ethris, there is great potential to target unmet medical needs in the field of non-invasive vaccine delivery.” Ethris and Lonza collaborate to develop spray-dried MRNA vaccines for respiratory disease prevention Nanoform Finland Plc, the medicine performanceenhancing company, today announced that it had started pivotal relative bioequivalence studies of Nanoenzalutamide, the nanocrystalline-enabled enzalutamide tablet formulation, a potential alternative to the amorphous solid dispersion (ASD) used in XTANDI® (enzalutamide)1, the number one prescribed androgen receptor inhibitor2 approved to treat prostate cancer. The studies are being conducted in fed and fasted healthy volunteers, for both U.S. and Europe. The purpose is to achieve bioequivalence for a single nanoformed 160 mg Nanoform starts pivotal human bioequivalence studies of nanoenzalutamide
7 TWENTYFOURSEVENBIOPHARMA Issue 2 / June 2025 tablet dose with four XTANDI® 40 mg film-coated tablets. With the clinical results we are on track to support product launch post expiry of the enzalutamide substance patent in the respective territories. The nanoenzalutamide tablet formulation was developed in a partnership with the ONConcept® Consortium (Bluepharma, Helm, Welding). Tablet-burden and dysphagia are well-documented challenges for prostate cancer patients, and the development of a nanoformed onceper-day regimen may be preferable for patients in need of reducing their daily pill burden. “We commenced this bioequivalence study as planned and our commercialization partners are excited about our CESS® technology, the IP advantages, the patient, sustainability & cost benefits and hence see significant commercial value in Nanoform’s technologies” said Prof. Edward Haeggström, CEO of Nanoform. The first license and supply agreement (LSA) has now been signed (Germany), while LSAs for several other key markets (e.g. US, Japan, France) are expected to be signed in the coming months. The total value the Nanoenzalutamide project could bring to Nanoform and its ONConcept® partners is EUR 10m+ in potential development milestones up until launch, EUR 25m+ in potential commercial milestones and significant profit share after launch. Nanoform continues to advance its other small and large molecule product kernels and customer projects to clinic. References 1. XTANDI® is a registered trademark of Astellas Pharma Inc. 2. Source: xtandi.com Ecolab Life Sciences announced it has launched an innovative new resin to help achieve cost savings and optimize operations throughout the antibody manufacturing process. Purolite™ AP+50 is an affinity chromatography resin with a 50-micron bead size offering the highest dynamic binding capacity of the AP resin platform while providing excellent durability for monoclonal antibody capture. It also leverages Ecolab’s patented Jetted resin bead manufacturing technology, an innovative approach that enables lot-to-lot consistency and shorter lead times. It is the latest addition to Ecolab’s robust Purolite Resin affinity toolbox which helps biopharmaceutical companies and Contract Development and Manufacturing Organizations solve complex purification challenges. “The ability to effectively improve process economics while maintaining purity is the gold standard of resin purification. As pharmaceutical and biotech companies seek to increase savings and improve business continuity, they are requiring innovative solutions to accelerate and de-risk manufacturing,” said Meeta Gulyani, senior vice president and general manager, Ecolab Bioprocessing. “Our resins are designed to help customers improve their product development platforms and implement next-generation manufacturing processes as well as enhance dual sourcing strategies that can reduce costs and bolster supply chains.” Purolite AP+50 resin joins Ecolab’s full suite of purification resins including the recently launched Purolite DurA Cycle™ A50 for longer lifetimes and Purolite 70 CH1 which targets complex antibody fragments. Together, they support process intensification strategies and cost of goods reduction, which are critical in late-phase, large-scale manufacturing. Ecolab’s newest innovation is being formally introduced at the 2025 BIO International Convention in Boston, Massachusetts from June 16 – 19, 2025. Attendees are invited to learn more about Purolite AP+50 resin at the Ecolab booth (#1971) and via a technical presentation at the BPI Theatre on Tuesday, June 17 at 2:40 p.m. EST. The announcement of Ecolab’s latest resin follows news of the opening of its newest Bioprocessing Applications Lab in King of Prussia, Pennsylvania. The new lab complements its UKbased facility, providing dual continent technical support capabilities, including resin screening and development applications to address growing customer demand around the world. Ecolab Life Sciences launches new bioprocessing purification resin to drive manufacturing productivity NEWS
8 TWENTYFOURSEVENBIOPHARMA Issue 2 / June 2025 Hovione and Firstgene announce strategic collaboration to advance virus-like particle platform for liver cancer NEWS Veranova, a global leader in the development and manufacturing of specialty and complex active pharmaceutical ingredients (API) for the pharmaceutical and biotech sectors, is pleased to announce the appointment of Elizabeth Rebeil as Global Vice President of Supply Chain and Operational Excellence. Ms. Rebeil brings more than 20 years of experience in supply chain management and continuous improvement within the pharmaceutical, life sciences, and manufacturing industries. Prior to joining Veranova, she served as Vice President of Supply Chain, Procurement, and Customer Service at QuVa Pharma. Her previous roles include Vice President of Global Biologics Supply Chain and Procurement at Recipharm, as well as leadership positions at Catalent, Wave Life Sciences, Shire Pharmaceuticals, and Lonza. Ms. Rebeil is a certified Lean Six Sigma Master Black Belt and holds an MBA from Tecnologico de Monterrey with a focus on Organizational Leadership. She is known for her strategic vision, transformative leadership, and ability to build high-performing teams that deliver measurable results. “Elizabeth’s deep expertise and proven track record in supply chain and operational excellence will be instrumental in helping Veranova achieve greater consistency, efficiency, and scalability across our global operations. We are excited to welcome Elizabeth to the team and look forward to the impact she will make for our customers and patients.” said Mike Riley, Chief Executive Officer of Veranova. Veranova appoints Elizabeth Rebeil as Global Vice President of Supply Chain and Operational Excellence Exclusive licensing and R&D collaboration accelerate the development of a novel gene vector platform for precision gene therapy in Hepatocellular Carcinoma - the third leading cause of cancer-related deaths worldwide Hovione, an international integrated pharmaceutical development and manufacturing organization, and Firstgene Life Sciences, a portfolio company of the Swiss incubator Xlife Sciences AG, announced a strategic collaboration to advance Hovione’s proprietary virus-like particle drug delivery platform for the targeted treatment of Hepatocellular Carcinoma (HCC), a therapeutic indication developed by Firstgene. Under the terms of the collaboration, Hovione will grant Firstgene an exclusive license to its proprietary novel targeted Adeno-Associated Virus (AAV)-Like particle technology for the treatment of HCC and will provide preclinical R&D services. The virus-like particle technology will be engineered and functionalized for the specific carcinoma cell type using therapeutically validated AAVs, including a novel primer compound. Hovione will be responsible for molecular engineering, the supply of tailor-made virus-like particles, and the execution of proof-of-concept studies. “We are thrilled to see our new gene vector particle platform adopted by Firstgene and its forward-thinking leadership team,” said Dr. Jean-Luc Herbeaux, Chief Executive Officer of Hovione. “We are proud to advance the development of innovative oncology treatments that address a critical unmet need for precision gene expression at the tissue level. This partnership is a testament to our mission of turning scientific complexity into real-world solutions that truly make a difference for patients.” “Firstgene is proud to highlight its collaboration with Hovione on this groundbreaking project. HCC, the most common liver cancer and a leading cause of cancer-related death, continues to represent a major unmet medical need. The combination of Hovione’s expertise in complex chemistry and particle engineering and the commercialization expertise of Xlife Sciences positions Firstgene well to offer patients potential new safe and effective therapy options”, said Dr. Alexander Zink, Managing Director of Firstgene Life Sciences GmbH.
Bespak, the specialist inhalation contract development and manufacturing organisation (CDMO) today released its first Environmental, Social and Governance (ESG) update. This update provides an overview of Bespak’s actions and progress in key material topics across its value chain. It sets out its planned future steps as part of a holistic approach to sustainable operations. Evolving regulations, as well as individual company ESG commitments, mean the pharmaceutical industry must decrease its carbon footprint, and CDMOs have a responsibility to help drive this change. Bringing together the three facets of ESG allows a business to understand its impacts in all aspects including direct and indirect impacts on the planet, people and natural ecosystems. Bespak’s ESG update is a key step in establishing transparency and accountability, as well as a path towards its sustainability goals. Bespak has a central focus on enabling the transition to low carbon pressurised Metered Dose Inhalers (pMDIs), but beyond this, the CDMO has many initiatives underway to tackle multiple aspects of its environmental impact. The ESG update details progress that has been made in Bespak’s first year, including: - Development of a flagship ESG strategy - Completion of its first doublemateriality assessment - Mapping of key stakeholders and value chain - Verification of baseline scope 1-2 greenhouse gas (GHG) emissions data - Establishment of an ESG & Enterprise Risk Governance Framework Chris Hirst, CEO of Bespak, said: “This ESG update marks an important early chapter for the new Bespak. It reflects the work we’ve done to begin embedding sustainability across the business, from product design and operations to the way we partner with customers and suppliers while planning for the future. It’s taken real commitment from our skilled and dedicated teams to get us here. As we look to the rest of 2025 and beyond, I’m confident we’re building on strong foundations.” Benedicta Bakpa, Head of ESG at Bespak, commented, “Our vision is to integrate sustainability across the inhalation supply chain. This update outlines the practical steps we’re taking and the groundwork we’ve laid to turn that ambition into action. We’re building the capacity to not only to meet our sustainability commitments, but to exceed them.’’ Bespak strengthens commitment to sustainability with the release of its inaugural ESG update 2024 NEWS
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NEWS Shilpa Biocare Private Limited, a fully-owned subsidiary of Shilpa Medicare Limited (“Shilpa”), announces ahead of BIO Boston that it has secured a Europe-wide commercial supply agreement with Orion Corporation for Recombinant Human Albumin. Shilpa’s Recombinant Human Albumin – a key plasma protein used in various therapeutic applications – is currently under development and will be manufactured using a robust non-human expression system. This provides improved safety, scalability, and virus-free production, addressing some of the key limitations associated with human-derived albumin. Under the terms of the agreement, Orion will gain exclusive rights to distribute, market and sell Shilpa’s Recombinant Human Albumin in Europe, with Shilpa receiving development and regulatory milestone payments from Orion. “We are pleased to strengthen our strategic partnership with Shilpa by collaborating on this novel product,” said Satu Ahomäki, EVP Generics and Consumer Health, Orion Corporation. “Recombinant human albumin will strengthen our strategy and offering in value-add hospital generics, and we look forward to making it available across Europe.” At BIO Boston, Shilpa is expected to see increased interest from biopharma innovators, particularly smaller biotech firms, leveraging its development capabilities in oncology and biologics – with the CDMO having both commercial facilities for both mammalian and microbial production. Madhav Bhutada, Managing Director, Shilpa Biocare, added: “Partnering with Orion is a significant step in bringing our innovative recombinant product to patients across Europe and is a testimonial of our developmental and manufacturing capabilities to bring Recombinant Human Albumin to market. This alliance aligns with our mission to provide high-quality, affordable biologics globally, and we are confident this partnership will further accelerate our footprint in the regulated markets.” Shilpa Medicare signs commercial supply deal with Orion for innovative Recombinant Human Albumin Intensified fed batch platform delivers titers >25g/L Aragen, a leading contract research, development and manufacturing organization (CRDMO), announced that it will commence GMP manufacturing at its biologics manufacturing facility in Bangalore, India from July 2025. Aragen has successfully completed the facility and equipment qualification and demonstrated the productivity of its intensified fed batch cell culture manufacturing platform to deliver titers >25 g/L. Aragen biomanufacturing site completes qualification with first GMP batches in July 2025
NEWS The news, released ahead of BIO Boston, comes on the back of several successful pharma customer audits with more biotech discussions expected to accelerate at the event. The facility opens with the flexibility to house multiple 2KL Single use bioreactors, set up for both fed batch and intensified fed batch production and can deliver one batch every 4-5 days at full capacity. Significantly, the bioreactors are configured with multiple 2KL units feeding into a single downstream purification suite. This provides flexibility to run multiple client projects in parallel or quickly scale up a customer’s production to commercial quantities. “The Aragen team has delivered a state-of-the-art facility to enable industry leading COGS and quality. Our first customer program will progress to GMP production as early as late July this year. The Bangalore manufacturing facility will help seamless transition to GMP manufacturing using not only intensified fed batch production, but also, our proprietary high-yield CHO-GS and CHO-DG44 cell lines,” commented Subodh Deshmukh, CEO, Biologics and President, Development. Jamie Cascio, AVP, Biologics, added, “The biologics manufacturing facility in Bangalore marks a significant milestone in Aragen’s evolution as an integrated, end-to-end solutions provider. With cutting-edge infrastructure and deep technical expertise under one roof, this facility is designed to seamlessly support our partners from early discovery through to commercial manufacturing. It strengthens our ability to offer speed, scalability, and compliance — enabling our customers to accelerate the journey of their biologics molecules to market with confidence.” The facility complements Aragen’s existing biologics capabilities in Morgan Hill, California and together will offer integrated services including cell line development, process & analytical development, QC and GMP manufacturing of monoclonal antibodies, biosimilars and other recombinant proteins. The California site already provides non-GMP manufacturing for batches from 1L to 50L across six separate suites. Aragen has completed more than 200 CLD projects, with over 100 of those cell lines in the clinic after successful IND filings. In fact, several Aragen-developed cell lines are now used by clients for the manufacture of marketed products in the US and worldwide.
14 TWENTYFOURSEVENBIOPHARMA Issue 2 / June 2025 NEWS Chrysalis, a GMP-ready space and service provider, officially launches following the acquisition of facility assets from Azzur Group and a strategic ownership investment to fuel future growth and expansion. With facilities in Massachusetts and North Carolina, Chrysalis offers flexible, GMP-compliant cleanroom spaces and support that help life science innovators and biopharma companies accelerate the development of transformative therapies. At a time where there is increasing pressures to progress quickly through key milestones to clinic and beyond, Chrysalis enables innovators to retain full ownership of their programs to meet their unique timelines and technical requirements. “Our model is particularly valuable for programs where retaining process control, protecting IP, and minimizing risk are crucial considerations,” said Sarah Stevens, CEO of Chrysalis. “Our approach gives our customers flexibility to take only the space and services they need, when they need it. By providing rapid access to GMPcompliant space and operational support, we empower our customers to advance on their own terms, transforming scientific promise into real progress without the burden of scheduling constraints or unnecessary ongoing expense.” With entry to cleanroom times as short as four to six weeks, Chrysalis offers tailored, cleanroom environments on flexible terms. This allows clients to flex manufacturing activities in line with their project needs and milestones, minimizing expenditure while maximizing control. Chrysalis partners with a wide spectrum of life science clients, from early-stage biotech companies to top 10 pharmaceutical firms, contract research organizations (CROs), and other life science stakeholders by providing fit-for-purpose space in key U.S. innovation hubs. Its facilities accommodate a wide array of therapeutic modalities and technical needs, helping clients maintain control and adapt quickly as their programs evolve. Sarah added: “Whether clients are navigating early development or preparing for commercialization, we’re here to grow with them. We don’t just provide space, we build partnerships grounded in collaborative operational excellence and a deep understanding of what it takes to operate in a GMP environment.” Chrysalis is positioned to scale rapidly, enhance its infrastructure, expand into additional geographies, and extend its service offerings to meet the growing demand for agile manufacturing solutions. Chrysalis launches with acquired cleanroom assets to deliver flexible manufacturing solutions
15 TWENTYFOURSEVENBIOPHARMA Issue 2 / June 2025 Ecolab Life Sciences has officially opened its new US Bioprocessing Applications Laboratory in King of Prussia, Pennsylvania. The new facility is designed to support biopharma customers with applications and process development for the purification of biotherapeutic molecules, providing comprehensive technical support to biopharmaceutical companies and contract manufacturers operating from small-scale to full commercial production. This new development location is well positioned in the Eastern U.S., close to many large pharmaceutical operations and a hub of bioprocessing innovation. The lab is equipped with highthroughput process development tools and manufacturing scale chromatography columns, enabling biotech firms to receive turnkey support for process development. Large biopharma companies can utilize the applications lab throughout the entire development cycle, from early to late stage and commercialization; including characterizing alternative resins to help reduce manufacturing costs and support with regulatory submissions. “Our new Bioprocessing Applications Lab marks a significant milestone in our ability to be a global technical partner to our customers around the world,” said Jennifer Sorrells, Ph.D., vice president of research and development, Ecolab Life Sciences. “This facility demonstrates our commitment to delivering best-in-class bioprocessing solutions by pairing Ecolab’s innovative resin toolbox with deep domain expertise to optimize the purification process. We are dedicated to empowering our customers to accelerate the delivery of life-saving therapies to market.” Biopharma and contract manufacturing organizations are already leveraging Ecolab’s Bioprocessing Applications Lab to help accelerate speed and enhance manufacturing efficiencies through lifecycle studies. The lab can initiate studies and deliver results within weeks, facilitating a faster route to market while providing customers with access to raw data and benchlevel operations for transparency and collaboration. The new lab complements Ecolab’s existing European Applications and Research & Development Lab, in Wales, U.K., and is part of the Ecolab Life Sciences Pharma Center of Excellence, a multi-million dollar investment which also includes an interactive learning space, The Xchange customer experience center, and an API (Active Pharmaceutical Ingredient) and excipient manufacturing facility. Ecolab Life Sciences opens new state-of-theart bioprocessing applications laboratory in Pennsylvania, US NEWS
16 TWENTYFOURSEVENBIOPHARMA Issue 2 / June 2025 NEWS Veranova, a global leader in the development and manufacturing of specialist and complex active pharmaceutical ingredients (APIs) for the pharmaceutical and biotech sectors, today announced a strategic investment to establish state-of-the-art bioconjugation development and cGMP manufacturing capacity at its Devens, Massachusetts campus. This expansion will enable Veranova to provide a more comprehensive suite of services to partners developing antibodydrug conjugates (ADCs) and other bioconjugates, and builds on the Devens facility’s extensive experience in the development and clinical and commercial manufacture of ADC linkerpayloads. Combined with a previously announced expansion of high-potent synthesis capacity in Devens, this will represent a more than $50 million investment into the site’s capabilities for ADCs and other bioconjugates and will create up to 70 new jobs. The new capacity is planned to come online in June 2026. The investment also addresses increasing demand for strong U.S.-based biomanufacturing capabilities and will help U.S.-based customers secure domestic supply chains for critical drug substances. The bioconjugation expansion will include new process and analytical development laboratories, grade C cleanroom space, development and cGMP equipment and instrumentation, and supporting infrastructure. These capabilities will support up to kilogram-scale manufacturing of potent and nonpotent bioconjugates. “We continue to see ADCs and other conjugated molecules as a key growth area as our customers look to develop more targeted therapies,” said Mike Riley, CEO of Veranova. “This investment will build on our core capabilities in complex chemistry, analytics and linker-payload synthesis, and leverage our strategically located cGMP infrastructure to provide a differentiated solution to our customers.” The Devens site is a key location in Veranova’s global manufacturing network, situated in close proximity to the Boston-Cambridge biotechnology hub. The site has over 15 years of experience in the development and manufacture of linker-payloads and other complex synthetic molecules supported by expertise in complex synthesis, analytical development and testing, high potent handling, crystallization development, and chromatography purification. Veranova Devens is an FDA-approved facility with capabilities spanning early process and analytical development, scaleup, and clinical and commercial manufacturing under one roof. Veranova announces strategic investment to establish cGMP bioconjugation capability in Devens, MA
18 TWENTYFOURSEVENBIOPHARMA Issue 2 / June 2025 NEWS AS Healthcare Advanced Synthesis SA (“HAS”), a leading international developer and producer of active pharmaceutical ingredients (APIs), high-potency active pharmaceutical ingredients (HPAPIs), and anticancer compounds, is pleased to announce today the successful completion of its previously announced acquisition of Cerbios-Pharma SA (Cerbios), a globally recognised manufacturer of chemical and biological APIs, including in the rapidly expanding area of antibody drug conjugates (ADCs). This strategic transaction marks a significant milestone for the two companies and sets the stage for the creation of a leading global solutions provider in the Contract Development and Manufacturing Organization (CDMO) industry. The acquisition is backed by 65 Equity Partners, a global investment firm dedicated to supporting family-owned businesses, founders, and entrepreneurs. Through this transaction, 65 Equity Partners becomes a c.40% shareholder alongside the Braglia family who retain majority control. The alliance of the two Swissbased companies, both with a global market presence, will drive innovation, accelerate extensive high-quality production capabilities, and deliver the cutting-edge chemical and biological expertise, technical excellence, and a wider range of services to address the dynamic needs of the global pharmaceutical industry. The new group, driven by a dedicated workforce of over 400 people, embodies a strong corporate culture and family ownership values that have long defined both companies, with a firm commitment to Switzerland’s Ticino region remaining at its core. The two companies have now united their forces, maintaining the highest standards of quality and service, ensuring seamless integration and continued support for all customers with the same enthusiasm and commitment to excellence, enabling them to achieve new and significant milestones. HAS Healthcare Advanced Synthesis SA completes the acquisition of Cerbios-Pharma SA to establish a top-tier global group in the CDMO industry, backed by 65 Equity Partners Lilly to acquire Verve Therapeutics to advance one-time treatments for people with high cardiovascular risk Verve’s leading programs aim to deliver lifelong cardiovascular risk reduction with a single dose by targeting genes strongly linked to cardiovascular disease Lilly’s established capabilities in cardiometabolic disease and genetic medicines are highly complementary to Verve’s vision and expertise. Eli Lilly and Company and Verve Therapeutics, Inc, a Bostonbased clinical-stage company developing genetic medicines for cardiovascular disease, announced a definitive agreement for Lilly to acquire Verve. Verve is developing a pipeline of gene editing medicines designed to address the
19 TWENTYFOURSEVENBIOPHARMA Issue 2 / June 2025 NEWS drivers of atherosclerotic cardiovascular disease (ASCVD) through treatments that may only need to be given once in a lifetime. Verve’s lead program (VERVE-102) is a potential first-in-class in vivo gene editing medicine targeting PCSK9, a gene linked to cholesterol levels and cardiovascular health. The treatment may be applicable for people who have heterozygous familial hypercholesterolemia (HeFH), a subset of ASCVD that affects 1 in 250 people in the general population, as well as certain patients with premature coronary artery disease (CAD). VERVE-102 is being evaluated in a Phase 1b clinical trial study and has been granted Fast Track designation by the U.S. Food and Drug Administration. “VERVE-102 has the potential to be the first in vivo gene editing therapy for broad patient populations and could shift the treatment paradigm for cardiovascular disease from chronic care to one-and-done treatment”, said Ruth Gimeno, Lilly group vice president, Diabetes and Metabolic Research and Development. “Lilly is eager to welcome our Verve colleagues to Lilly and continue the development of these promising potential new medicines aimed at improving outcomes for patients with cardiovascular disease and addressing the significant unmet medical need in this space”. “Verve was founded with one mission in mind: transform the treatment of cardiovascular disease from chronic care to a one-dose future,” said Sekar Kathiresan, M.D., co-founder and chief executive officer of Verve Therapeutics. “In just seven years, our team has progressed three in vivo gene editing products, with two currently in the clinic. Now, we will take the next steps in the drug development journey together with an ideal strategic partner in Lilly. Lilly shares our vision, and we believe their global research, clinical, regulatory and commercial capabilities will help to accelerate the development of our medicines. My deepest thanks to the entire Verve team for their expertise, creativity, and grit. We are grateful to the investigators and patients who have contributed to the success of our clinical trials so far. Under Lilly›s stewardship, we are excited to realize the next chapter in cardiovascular care where a single treatment can lead to lifelong reduction of cardiovascular risk factors and make life better for millions of patients living with cardiovascular disease”. Under the terms of the agreement, Lilly will commence a tender offer to acquire all of the outstanding shares of Verve for a purchase price of $10.50 per share in cash (an aggregate of approximately $1.0 billion) payable at closing, plus one nontradeable contingent value right (CVR) per share that entitles the holder to receive up to an additional $3.00 per share, for a total potential consideration of up to $13.50 per share in cash without interest (an aggregate of up to approximately $1.3 billion). CVR holders would become entitled to receive the contingent payment upon the first patient being dosed with VERVE-102 for ASCVD in a U.S. Phase 3 clinical trial on or prior to the tenth anniversary of closing or termination of the CVR. There can be no assurance that any payments will be made with respect to the CVR. The transaction is not subject to any financing condition and is expected to close in the third quarter of 2025, subject to customary closing conditions, including the tender of a majority of the outstanding shares of Verve›s common stock. Following the successful closing of the tender offer, Lilly will acquire any shares of Verve that are not tendered in the tender offer through a second step merger at the same consideration as paid in the tender offer. The purchase price payable at closing represents a premium of approximately 113% to the 30-day volume-weighted average trading price of Verve’s common stock ended on June 16, 2025, the last trading day before the announcement of the transaction. Verve’s board of directors unanimously recommends that Verve’s stockholders tender their shares in the tender offer. To demonstrate their commitment to the transaction, Sekar Kathiresan, Andrew Ashe and entities affiliated with GV have signed tender and support agreements whereby they agreed, subject to certain terms and conditions, to tender their shares in the tender offer. The shares subject to the agreements that are beneficially owned by such stockholders represent a total of approximately 17.8% of Verve’s outstanding common stock. Lilly will determine the accounting treatment of this transaction in accordance with Generally Accepted Accounting Principles (GAAP) upon closing. This transaction will thereafter be reflected in Lilly’s financial results and financial guidance.
20 TWENTYFOURSEVENBIOPHARMA Issue 2 / June 2025 NEWS From cutting-edge biomedical platforms for drug testing to digitaltwin technologies that shorten pre-clinical timelines—and with them a full menu of investment opportunities across Italy’s regional ecosystems and national research networks—the country’s life-science sector heads to the BIO International Convention 2025, taking place in Boston June 16-19, ready to make its case on the global stage. The Italian delegation—organized by the Italian Trade Agency (ITA), the Ministry of Foreign Affairs and International Cooperation, and the Ministry of Enterprises and Made in Italy, with the support of Farmindustria, Federchimica Assobiotec, and Invitalia—brings together marketleading companies and innovative enterprises alongside regional clusters, research centers, science parks, and investment-promotion agencies, offering attendees a comprehensive showcase of advanced technologies and location-based opportunities for industrial and R&D partnerships. The BIO International Convention 2025, set for June 16–19 at the Boston Convention & Exhibition Center, ranks among the world’s premier biotech gatherings. This year’s edition is expected to draw roughly 20,000 professionals from more than 60 countries and canvasses the entire ecosystem—large pharmaceutical companies, start-ups, investors, regulators, and research centers—through a dense schedule of scientific and business sessions. Erica Di Giovancarlo, Director of the ITA New York Office and Coordinator of the Italian Trade Agency’s U.S. network, explains: “Italy’s presence at BIO Boston reflects years of work by the Italian Trade Agency to promote an integrated system of scientific expertise, cutting-edge research infrastructure, and high-tech industrial supply chains. Gathering under a single national pavilion—once again organized by ITA— lets our companies show international partners the full journey from idea to production, backed by a deep talent pool and a manufacturing base that accounts for 23 percent of Europe’s CDMO value (contract development and manufacturing). Thanks to the incentives offered by local authorities and the experience our industry has built, Italy is an ideal place to develop, test, and scale biotech solutions, with innovation acting as a powerful engine for growth both for the country and for global players that choose to invest on our soil.” The Director General of the Italian Ministry for Foreign Affairs Mauro Battocchi affirmed that “Italy is an export powerhouse, constantly among the top 10 exporters globally, but not many are aware that Pharma is among those top exports. That result would be unthinkable without strong scientific, R&D and manufacturing bases. The Global Biotech Montalcini Tour is also aimed at bringing a new and more updated narrative about Italy, particularly in Life Science.” The Head of Technological Innovation and Startup at the Italian Ministry for Foreign Affairs Massimo Carnelos added: “By supporting our emerging biotech companies in their global expansion, the Italian Foreign Ministry and Italian Trade Agency stand behind our leading tech entrepreneurs and their disruptive technologies in Life Science and Biotech. Italy has so much to surprise and to offer, but unfortunately is still unrated. We are here at the Bio USA to tell and prove a different story”. Italy is a major biotech player in Europe: the life-science supply chain accounts for 11% of national GDP, and the country’s pharmaceutical industry counts 770 production sites, the second-highest total in the EU (source: stat). On the services side, Italy leads Europe in CDMO output—contract development and manufacturing—at €3.6 billion, or 23% of EU value (source: Farmindustria). Italian exports of drugs and biotech products topped €52 billion in 2024, the fastest growth among the continent’s large economies over the past five years (+60% according to Eurostat). Innovation is fueled by €2 billion in R&D spending in 2023 (+25% since 2019) and more than 7,000 dedicated researchers. The talent pipeline is strong, with 76,000 life-science graduates and 350,000 students each year, while Italy’s scientific output ranks among the world’s most cited across multiple life-science disciplines (source: Invest in Italy). The transatlantic numbers are equally solid. In 2024, chemicals and pharmaceuticals were Italy’s second-largest export category to the United States, making up 18% of total U.S. imports from Italy. In value, U.S. imports of Italian chemical-pharma products reached $13.7 billion, up 31.4% year-over-year. Within that, biotech stood out: American imports of Italian biotech solutions hit $4.4 billion, a 112% jump versus 2023. On June 16, as the Convention opens, the Consulate General of Italy in Boston will host a stop on the Montalcini Global Biotech Tour—an event series organized by the Italian Trade Agency and the Ministry of Foreign Affairs and International Cooperation to showcase Italy’s emerging biotech innovators on the world stage. The gathering will bring together the Italian delegation and key U.S. stakeholders from the Boston ecosystem, aligning with the strategic roadmap set out by From molecule to market: Italy’s end-to-end life science ecosystem heads to BIO Boston
21 TWENTYFOURSEVENBIOPHARMA Issue 2 / June 2025 the MFA-led Working Group on the internationalization of Italy’s biotech industry. The Tour—whose itinerary spans the globe from San Francisco to Singapore—aims to translate the think tank’s recommendations into the U.S. market and lay the groundwork for new industrial and scientific partnerships. The Consul General of Italy in Boston Arnaldo Minuti commented: “We are pleased to welcome the Montalcini Global Biotech Tour to the Consulate General of Italy in Boston, an initiative that celebrates Italian scientific excellence and promotes dialogue with one of the most advanced and competitive biotech ecosystems in the world. Boston is home to nearly 1,000 biotech companies and over 140,000 life sciences professionals. Italy is an integral part of this global network through leading companies, strategic investments, and a vibrant community of Italian researchers, scientists, and executives. This event offers a valuable platform to foster new collaborations, strengthen economic ties between Italy and the US, and the Italian contribution to global innovation and health”. The Italian Pavilion at BIO 2025 Italian companies traveling to Boston will showcase technologies that span the entire life-science value chain. Highlights range from 3DD “beating” organ-on-chip models for highly predictive drug testing to hematopoietic stem-cell therapies; first-in-class plant-based immunotherapies for autoimmune diseases; in-silico simulation platforms and digital twins that forecast a compound’s safety and efficacy; AI-powered, non-invasive metabolic diagnostics; and super-resolution fluorescence microscopy systems. On the manufacturing side, Italy’s CDMOs cover every link in the chain—from complex API synthesis and GMP-grade plasmid and mRNA production for vaccines and advanced therapies to large-scale oral soliddosage formulation. Alongside these solutions, regional clusters, science parks, and investment-promotion agencies will present territorial ecosystems, incentives, and infrastructure—from local life-science networks and soft-landing programs to precisionmedicine hubs, biotech parks, and specialized IP services coordinated by the national Invest in Italy unit. Exhibitors in the Italian Pavilion at BIO 2025 include Anemocyte (Varese), BiomimX (Milano), Chemi (Milano), CrestOptics (Roma), Diamante (Verona), Genenta Science (Milano), ICROM (Monza), InSilicoTrials (Trieste), Math Biology (Roma), Menarini Biotech (Roma), Valpharma International (Rimini). They are joined by the Ri.MED Foundation, the HEAL Italia Foundation and Società Italiana Brevetti. On the institutional side, Boston will host Bioindustry Park “Silvano Fumero”, Clust-ER Health EmiliaRomagna, Cluster Lombardo Scienze della Vita, Invest in Lombardy, Invest in Trentino, Invest in Tuscany, Life Science Cluster Friuli Venezia Giulia – Polo Tecnologico Alto Adriatico, Select Friuli Venezia Giulia, YesMilano. NEWS Ahead of opening, Enzene expands scope for biomanufacturing at New Jersey site Enzene, a pioneer in fully-connected continuous biologics manufacturing technology, announced that ahead of the official opening of its biologics manufacturing facility in Hopewell, close to Princeton in New Jersey, it has expanded its plans for the site. Located in the heart of the Northeast’s biopharma corridor, the site will now incorporate a further 26,000 square feet of drug substance manufacturing suites, laboratories, storage, dispensing and warehousing. “We will officially open our site later this year but are already producing non-GMP batches and seeing strong demand from U.S.- based small- and medium-sized innovators as we look ahead to GMP readiness,” commented Norm Stoffregen, SVP and site head at Hopewell. “With construction already well advanced, it made sense to seize the opportunity to add to the 54,000 square feet we had already planned, so that we could include additional capacity, larger dedicated quality control and development laboratories, and the space we will need for materials and finished goods.” As well as conventional fed-batch drug substance manufacturing, the expanded scope of development will make extensive use of the modular EnzeneX™ 2.0 platform, which occupies a smaller footprint than that of conventional systems. The platform, which uses the first fully-connected continuous manufacturing™ (FCCM™) technology, leverages optimized cell media to boost cell productivity and efficiency, while also incorporating process analytical technology (PAT) to enable real-time monitoring and control for consistent quality and optimized processing. It is capable of clinical phase GMP supply from as low as 30-liter scale, with variable bioreactor capacity to accommodate scale-on and scaleout expansion.
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