COPERTINA 24/7 BIOPHARMA ISSUE 1 2026
1 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026 WELCOME ELLIE BRUNI Publishing Director TWENTYFOURSEVENBIOPHARMA Introducing the 2026 launch issue of 24/7 Biopharma, arriving during DCAT Week 2026 in New York. As proud members and media partners of DCAT, we’re excited to share a collection of stories across our digital platforms and website that reflect the people and progress influencing biopharma today. Inside you’ll find timely news, hands-on features. We celebrate real breakthroughs, from expanding mRNA and gene-therapy pipelines to AI-powered discovery and continued investment in advanced biologics manufacturing. You’ll read case studies from teams turning new platforms into treatments, interviews with leaders navigating complex partnerships, and technical pieces on manufacturing approaches that aim to cut costs and speed delivery to patients. At the same time, the industry faces hard realities. Supply chains remain fragile, raw-material sourcing is tangled by geopolitical strain, and workforce gaps complicate both R&D and production. Recent trade and regulatory moves are only part of the picture, they raise questions about tariff exposure and broader market uncertainty. Now is the moment for companies to pressure-test sourcing plans, lean into AI-driven forecasting, and build practical scenario plans. Resilience and clear, disciplined planning will matter more than ever as trade dynamics shift. In conclusion, as we reflect on our progress and look toward the future, let us focus on fostering resilience across the 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 around the world. We look forward to engaging discussions and shared insights during this important week. We hope this issue informs and inspires you. If you’d like to contribute an editorial, commentary, or news tip, please send submissions to editor@247biopharma.com or visit https://247biopharma.com, we’d love to hear from you. 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 2026. No part of this publication can be reproduced or transmitted in any form without the express permission of the publisher. ISSN 2516-4481
34 LONZA Strategic growth in biologics manufacturing: Insights from Lonza’s acquisition of the Vacaville site 36 LGM PHARMA Designing API supply chains for global uncertainty 40 PROCOS Unlocking next-level production: PROCOS’ R11 facility goes live 42 INDENA Engineering excellence in high potency manufacturing WOMEN IN SCIENCE 58 ARTIFICIAL INTELLIGENCE AI in healthcare market CONTENTS 1 WELCOME NEWS 4 27 GRIFOLS Company profile 28 LONZA Navigating the complex landscape of GMP-compliant exosome manufacturing: Challenges, regulatory insights and future directions
3 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026 CONTENTS SIMONA SERBAN Global Life Science Applications Director 54 SUNRESIN - Interview Women leading change at Sunresin CAROLINE TINSLEY Sales Manager of Life Science Division (Europe) ALESSANDRA BASSO Global Sales and Marketing Director of Life Science Division MARIA TERESA TICOZZELLI Quality System Team Coordinator 46 HAS GROUP - Interview A woman’s view from the HAS Group 50 ROUNDTABLE To tie in with International WOMEN IN SCIENCE BONUS FEATURES from page 65
4 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026 NEWS CordenPharma Colorado partners with BioMed Realty on peptide development lab expansion at Flatiron Park in Boulder BioMed Realty, the largest private owner and operator of real estate for the life science, technology and innovation industries, announced that CordenPharma Colorado, a leading peptide drug substance Contract Development and Manufacturing Organization (CDMO), has leased 64,000 square feet at Flatiron Park’s 5505 Central – Boulder’s first purpose-built speculative lab building – near the existing CordenPharma Colorado facility. Flatiron Park is BioMed Realty’s premier Boulder campus, supporting life science, quantum and technology tenants through highly resilient infrastructure, flexible building solutions, and a thoughtfully curated campus environment. CordenPharma Colorado’s 15-year lease reinforces Flatiron Park’s position as a critical hub for innovation, and validates BioMed Realty’s substantial, longterm investment in the Boulder innovation ecosystem. CordenPharma Colorado will be the sole tenant at 5505 Central. The new LEED® Gold-certified facility features robust power capacity, adaptable lab grids, advanced mechanical and utility systems, and efficient waste disposal to support complex scientific operations. Strategically located adjacent to CordenPharma Colorado’s large-scale peptide manufacturing facility, the space will house process development and analytical services, enabling seamless integration of advanced peptide Active Pharmaceutical Ingredient (API) production from development through commercialization. Beyond Colorado, the expanded peptide development capabilities Picture. (CordenPharma Photo) CordenPharma Colorado is leasing 5505 Central, a newly completed, purpose-built peptide development lab at Flatiron Park in Boulder, CO (US). - CordenPharma Colorado expands its leadership in complex peptide development with the lease of a new 64,000 sq. ft. LEED® Gold-certified facility in Boulder, Colorado (US), strengthening its position as a premier global CDMO delivering advanced peptide APIs from early development through commercialization. - The new process development and analytical labs enable seamless scale‑up from early development to full commercial peptide API manufacturing, leveraging the proximity of CordenPharma’s nearby large‑scale facility. - The expanded peptide development capabilities will be fully integrated into CordenPharma’s growing global facility network, enabling pharma and biotech partners access to end‑to‑end peptide drug substance and drug product supply chain, including First-in-Human clinical trial peptide production, extensive sterile injectable drug product capacity and advanced oral solid peptide delivery services. - CordenPharma Colorado is growing its team to support this expansion, inviting scientists and specialists to explore open roles and join a world‑class peptide development organization. Visit cordenpharma.com for more information. created at this location will be integrated into CordenPharma’s growing global network across Europe and the U.S. “We’re excited to partner with BioMed Realty on this project to accelerate our strategic growth and meet customer demand for complex peptide outsourcing, while creating additional jobs and attracting research talent to the region,” said Michael Landau, Managing Director of CordenPharma Colorado. “With our strong team and strategic vision, backed by our global facility network, these new labs will grow the life sciences sector in Boulder. As a CDMO, our Development Laboratories are foundational in delivering effective support to customers and their patients.”
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6 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026 Almac Sciences, a member of the Almac Group, is pleased to announce a significant expansion of its API and flow chemistry services with the launch of cGMP compliant flow high pressure hydrogenation. This new capability brings enhanced precision, safety, and scalability to one of the most critical transformations in modern synthetic chemistry and is now available for both clinical and commercial manufacturing programs. Hydrogenation is an essential step across many synthetic routes and performing it under continuous flow conditions offers transformative benefits. Flow operation provides superior control over temperature, pressure, and mixing, enabling improved reaction performance, reduced impurity formation, and reliable reproducibility at scale. By integrating this technology under cGMP conditions, Almac Sciences now gives clients access to faster, safer, and more efficient hydrogenation up to 100 bar pressure and 300 deg C with the confidence of full regulatory compliance and rigorous analytical oversight. This advancement builds on over eight years of substantial investment in flow chemistry, during which Almac Sciences has developed deep expertise in packedbed hydrogenation and demonstrated robust performance at scales exceeding 100 kg. The addition of cGMP capability further strengthens Almac’s position as a leading provider of manufacturing solutions. “This investment marks a significant milestone for our team and our clients,” said Dr. Scott Wharry, Associate Director of Custom and Flow Chemistry at Almac Sciences. “By combining cGMP flow hydrogenation with our established expertise in cryogenic organometallic chemistry and large scale packedbed hydrogenation, we are offering continuous processing capability today. These technologies not only improve safety and efficiency but also align with the industry’s drive toward sustainability and innovation.” With this latest investment, Almac Sciences continues to expand its comprehensive continuous flow offering, providing global partners with cutting-edge technologies backed by the company’s multidisciplinary team of chemists, engineers, analysts, automation specialists, and project managers. This integrated expertise ensures clients receive not only technical excellence but also strategic guidance and support at every stage of their molecule’s journey. Prof. Tom Moody, VP API Development and Commercialisation, added: “Flow hydrogenation under cGMP is a major step forward for our customers. It delivers enhanced process confidence, consistent high quality output, and exceptional scalability, all while reducing environmental impact and operational risk. As the industry increasingly prioritises safer, greener, and more flexible manufacturing solutions, this capability reinforces our commitment to supporting clients from early development right through to commercialisation.” Almac Sciences launches new cGMP flow hydrogenation capability The company’s latest flow chemistry investment strengthens continuous processing offering for clinical and commercial manufacturing programs NEWS WE DON’T JUST PUBLISH NEWS. WE PUBLISH EXTRA-ORDINARY VISIONS
8 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026 NEWS Olon, a global CDMO and generics manufacturer, and Zymvol, a leader in computational enzyme discovery and enzyme-enabled product development, today announced a strategic collaboration designed to accelerate the adoption of biocatalysis as a practical, scalable manufacturing solution for the pharmaceutical industry. The collaboration brings together Zymvol’s physics-AI powered enzyme design with Olon’s industrial-scale biomanufacturing capabilities, creating an end-to-end pathway from enzyme discovery to ton-scale production. This partnership directly addresses the cost, timeline, and scale-up challenges that have historically limited the widespread industrial adoption of biocatalysis. Enzyme-enabled manufacturing routes offer a compelling pathway to lower costs, improved sustainability, and more resilient supply chains. The Olon–Zymvol collaboration builds on this potential by combining advanced computational enzyme design with proven large-scale fermentation, process development, and manufacturing expertise, enabling faster development, reduced risk, and reliable translation from laboratory innovation to industrialscale production. Under the agreement, Zymvol’s physics-based, AI-enhanced enzyme discovery and optimization platform will support Olon’s customer and proprietary projects. In parallel, Olon will make its extensive fermentation scale-up, process development, and manufacturing infrastructure available for Zymvol’s self-funded and customerpartnered programs. “Biocatalysis has long been scientifically compelling, but commercial adoption has been held back by uncertainty, long timelines, and scale-up risk,” said Maria Fátima Lucas, CEO and Founder of Zymvol. “Our physics-based, AI-driven approach makes enzyme performance predictable before a project ever reaches the lab. By partnering with Olon, we can translate that digital certainty directly into industrial reality, significantly reducing time, cost, and risk from enzyme discovery to full-scale production.” From Olon’s perspective, the collaboration strengthens its ability to support customers seeking innovative and reliable manufacturing routes under real-world industrial constraints, while also transferring these benefits to its proprietary products and supporting sustainable development and continuous improvement of its internal pipeline. Sustainability is part of how Olon works every day, shaping decisions and guiding continuous improvement across the company. “Discovering enzymes is only part of the challenge; the real test is scaling them reliably, efficiently, and on schedule,” said Dr. Ester Masllorens, SVP Global R&D at Olon. “By integrating Zymvol’s predictive enzyme design capabilities with our fermentation, process development, and large-scale manufacturing expertise, we can help customers move from early concepts to ton-scale production with far greater confidence, while applying green chemistry principles to enable more sustainable, low-impact manufacturing processes. This collaboration reinforces Olon’s role as a partner of choice in advanced biomanufacturing”. The partnership also builds on Olon’s long-standing industrial expertise, including more than 60 years in microbial fermentation, over 30 years in recombinant protein production, and 20 years of know-how in mammalian cell culture. With a total fermentation capacity of approximately 5,000 m³ across a wide range of fermenter sizes, Olon is one of Europe’s largest third-party fermentation providers. Olon operates a robust European biomanufacturing network, anchored by two major bio-hubs in Italy and strengthened by the addition of two French sites acquired in 2024, enhancing its ability to support large-scale biocatalytic manufacturing across Europe. Together, Zymvol and Olon aim to make enzyme-based manufacturing routes faster to develop, lower risk to scale, and commercially viable as a repeatable solution for pharmaceutical and specialty chemical producers facing increasing pressure on efficiency, sustainability, and supply-chain resilience. Olon and Zymvol remove key barriers to industrial-scale biocatalysis in pharmaceutical manufacturing
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10 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026 The Flamma Group (“Flamma”), a global, fully integrated, Contract Development and Manufacturing Organization (CDMO) of New Chemical Entities (NCEs) and late stage intermediates for Innovator Companies, announces that its Flamma USA site, located in Malvern, PA, has successfully passed its first US Food and Drug Administration (FDA) inspection. The pre-approval inspection (PAI) took place over the course of four days for an API that the Flamma USA site will manufacture for a global pharmaceutical company. The inspection covered the entire facility including the manufacturing equipment and quality system, and the site was found to be compliant with all FDA GMP requirements. The Malvern, PA site was acquired by Flamma in late 2019. Since the acquisition, the site has seen investments over $3M in order to align it with Flamma’s manufacturing and quality standards. The site is focused on early-stage small molecule drug development and manufacture of APIs whether they be small volume, orphan and niche indication APIs. “This is a tremendous achievement for Flamma USA. Since day one, the site’s goal has been to help customers move their molecules into the clinic for Ph. I studies and onward as quickly as possible,” states Gianmarco Negrisoli, President of Flamma USA. “Our team has worked very hard to bring the site to this level. This milestone serves as a testament to our enduring commitment to the highest standards of quality and regulatory compliance. It affirms our continued capability to strengthen our global presence as a trusted, stable, and dependable partner.” The Flamma USA site consists of 5 GMP kilo-labs, GMP HPAPI suite, GMP pilot plant, GMP clean room along with an R&D lab with 16 hoods. The site allows our team to work efficiently and effectively for customers looking to leverage the entire Flamma global network. Flamma recently hired Craig Dixon as its Site Director. With over 25 years of experience in the industry, Craig brings extensive understanding of the CDMO marketplace, across development, commercial and operations. NEWS Flamma USA successfully passes FDA inspection JOIN THE EXTRAORDINARY REVOLUTION. WE ARE EXTRA-ORDINARY!
11 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026 NEWS Grifols is strengthening its medical plastics proposition by leveraging the Murcia plant (located in Spain) available capacity and proven expertise in manufacturing medical plastic components, medical devices, and empty bags for healthcare applications. With strong quality and regulatory framework, the Murcia site is positioned to support new medical plastic projects and partnerships, offering customers scalability, flexibility, and certified quality. What we can offer Murcia’s medical plastics scope includes 2 core technology platforms: - Injection components (e.g., connectors, adapters, functional parts) - Bag welding (e.g., IV solution bags, anticoagulant bags) Product types we can support Using these technologies, Grifols can provide a broad range of medical plastic solutions, including: - Empty bags: in different types of materials and formats - Medical device instruments and sub-assemblies: including device aggregations and instrument components (e.g., robotic-arm related parts) - Consumable components: MTUs, twist-off systems, connectors, adapters, holders, IVD plastic parts, pipette tips, racks, and related items Grifols can also adapt products to customer requirements, supported by existing molds and adaptable machinery, and in-house engineering expertise to design specialized equipment when needed. Materials and technical scope Our facility works with a broad set of medical-grade polymers, including polypropylene (PP), acrylonitrile butadiene styrene (ABS), polyoxymethylene (POM), polycarbonate (PC), polyethylene terephthalate (PET), polyethylene (PE), polyamide (PA), polystyrene (PS) and polyvinyl chloride (PVC) enabling support across multiple customer specifications and use cases. Other films like, PP/EVOH, aluminium foil, PET/SiOx are also used for parenteral bags. Trusted quality and regulatory compliance Murcia operates under Grifols robust quality systems and certifications, including ISO 13485:2016 & CE Mark, GMP, MDSAP, ISO 14001, ISO 45001, and Spanish Health Authorities licenses, as well as an FDA Establishment Identifier. Proven partner experience The site already supports global external customers demonstrating readiness for contract manufacturing and partnerships. Interested in tailored medical plastic components or empty bag solutions? Grifols expands its CDMO Parenteral business by offering the manufacturing of medical plastic components GNL-CM-2600015
12 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026 NEWS Sartorius is addressing the increasing demand for faster and more efficient cell line development (CLD) by launching a new genetically engineered CHO host cell line that improves productivity and efficiency. The team leveraged proteomic profiling and targeted genome editing to generate the rationaldesign host cell line, which multiplies productivity by up to three-fold. Sartorius tested the new CHO host cell line across multiple CLD campaigns from DNA to lead clone expressing a range of different therapeutic proteins. At five-liter bioreactor scale, the new host demonstrated up to a two-fold increase in expression titers, and up to a three-fold increase in productivity when directly compared against lead clones derived from the original wild-type CHO host in traditional fed-batch processes. The cell line enabled this productivity increase while maintaining high product quality. This robust performance has shown to be consistent across IgG1, IgG4, Fc-fusion, and bispecifics, making it well-suited for a wide range of biotherapeutic modalities. In intensified bioprocessing, the engineered host also supports higher titers and long culture duration in continuous perfusion. For a selected clone expressing a monoclonal antibody, Sartorius observed a twofold increase in titer per day along with maintained high cell density and viability (more than 80 percent) for a culture duration of up to 28 days. The data demonstrate that the host’s productivity gains make it ideal for supporting next-generation costeffective biomanufacturing processes, including the growing biosimilars market. The cell line is designed for reliability, with more than 90 percent of evaluated clones demonstrating continuous protein expression and maintaining low gene copy number over more than 70 generations, ultimately supporting long-term manufacturing consistency along with regulatory confidence. “To the best of our knowledge, this is the first engineered CHO host cell line to deliver performance at this exceptional level in the CLD market,” said Oscar Reif, Head of Corporate Research and CTO at Sartorius. “Its development was made possible only through the combined strengths of our expertise in data science, gene editing, and bioprocessing, reinforcing our position as a leader in innovative CLD technologies. This achievement only marks the beginning — our data scientists and cell engineers are already advancing the next generation of cell lines to push these innovations even further.” Combining this new host with a true data-driven workflow strengthens the Sartorius cell line development platform and delivers higher productivity and greater stability in as little as nine weeks, helping developers reduce risk and improve overall manufacturing efficiency and cost per dose. Sartorius has extensive experience in CLD. The company has completed more than 330 projects and has a strong regulatory track record, with more than 85 molecules in clinics with 10 achieving market approval. Sartorius launches rational-design CHO host cell line with up to three-fold increase in productivity GSK and Alfasigma announce agreement on worldwide rights for linerixibat GSK plc and Alfasigma S.p.A. announced a licence agreement under which Alfasigma will acquire worldwide exclusive rights to develop, manufacture and commercialise linerixibat, an investigational ileal bile acid transporter (IBAT) inhibitor being developed for cholestatic pruritus in primary biliary cholangitis (PBC). Alfasigma is a global pharmaceutical company with established capabilities in specialty care and rare diseases. The company has significant experience in developing and commercialising therapies for serious liver diseases, including PBC, and has products in more than 100 markets worldwide. Tony Wood, Chief Scientific Officer, GSK said: “We’re proud of the role GSK has played discovering and developing linerixibat to advance treatment in this rare disease with high unmet need. We believe Alfasigma, given their expertise in PBC, is the right partner to take this medicine forward for patients. This agreement sharpens GSK’s focus to deliver our next wave of liver disease innovation, including potential treatments for chronic hepatitis B, MASH and ALD, which account for two million deaths annually and have a major impact on healthcare utilisation.”
13 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026 Ardena appoints Paul Edwards as Chief People Officer Ardena, a specialist pharmaceutical CDMO and bioanalytical CRO advancing precision medicines, today announces the appointment of Paul Edwards as Chief People Officer. He will lead Ardena’s global people strategy, strengthening organizational capability and supporting the company’s continued international growth. Paul brings over 30 years of Human Resources leadership experience in complex, science-driven organizations. He joins Ardena after 16 years at Catalent Pharma Solutions, where he most recently served as Vice President, Human Resources. In that role, he led international HR teams across multiple business units and geographies, shaping people strategies aligned with operational expansion, organizational design and leadership development. At Ardena, Paul will focus on strengthening leadership capability, building a high-performance culture and ensuring the organization is structured to support productivity, speed and scalability. His mandate includes simplifying structures, clarifying accountability and developing the talent and engagement frameworks required to enable efficient execution across the business. Jeremie Trochu, Chief Executive Officer of Ardena, commented: “I’m delighted to welcome Paul onto our team. His track record in leading global HR organizations within the biopharma services sector makes him a very strong addition to our executive team. As Ardena continues to expand its capabilities and footprint internationally, investing in our people, leadership and culture is essential to delivering for our customers. Paul will play a key role in ensuring our organization evolves in line with our strategic ambitions.” Paul Edwards added: “Ardena has a clear strategy and very strong scientific and technical foundations. I look forward to working with my new colleagues across the organization to further develop our leadership capability, support talent development and foster a high-performance culture that enables sustainable growth.” Paul holds a joint honours degree in Law and Politics from Durham University in the United Kingdom and is based in New Jersey, USA. NEWS Linerixibat has been granted Orphan Drug Designation in the US, EU and Japan, and priority review in China, for the treatment of cholestatic pruritus in patients with PBC. Marketing applications for linerixibat are currently under regulatory review in the US, EU, UK, China and Canada, based on positive data from the GLISTEN phase III trial. GLISTEN met primary and key secondary endpoints, demonstrating a rapid, significant and sustained improvement in cholestatic pruritus and itch-related sleep interference versus placebo. The safety profile of linerixibat was consistent with previous studies and the mechanism of IBAT inhibition. Linerixibat is not currently approved anywhere in the world. Francesco Balestrieri, Chief Executive Officer, Alfasigma, said: “Alfasigma is committed to advancing rare and specialty care by developing and delivering innovative solutions that address some of the most complex healthcare challenges. With our deep hepatology expertise and strong global footprint, we are uniquely positioned to lead the worldwide commercialization of linerixibat. This agreement underscores our strategic focus on bringing meaningful new treatments to patients and improving outcomes for communities around the world.” Financial considerations Under the terms of the agreement, GSK will receive an upfront payment of $300 million, plus $100 million upon US FDA approval (expected prior to transaction closing, based on current PDUFA target approval date of 24 March 2026). Additionally, GSK is eligible to receive $20 million upon EU and UK approval, and up to $270 million in sales-based milestone payments. GSK will also earn tiered double-digit royalties on net sales worldwide. This transaction is subject to customary conditions, including applicable regulatory agency clearances such as under the HartScott-Rodino Act in the US.
Neuland Laboratories will open its new commercial peptide facility in the summer of 2026 at its 17-acre Bonthapally manufacturing campus, with further capacity expansions planned as client demand increases. The first of four planned modules is expected to be operational by the summer of this year, adding commercial-scale capabilities to Neuland’s existing clinical-stage S-Block facilities. Module One has seen $30million already committed, with the total investment potentially rising to $80million Once open, Module One will provide 6,500 L of SPPS [solid phase peptide synthesis] and LPPS [liquid phase peptide synthesis] reactor capacity – for sizes of 250 L to 3000 L in LPPS, as well as SPPS reactors up to the 500 L scale. Construction of the facility began last year and will enable client execution from small scale to multi ton commercial volumes, while also providing the flexibility needed for complex and long chain peptide programs. With GLP-1 manufacturing consuming a growing share of global peptide capacity, Neuland is targeting innovator and emerging biotech programs facing tightening access to clinical and commercial manufacturing across a broad range of indications. Saharsh Davuluri, Vice Chairman and MD at Neuland Labs, added: “The site has been designed for ongoing expansion, with space to accommodate additional SPPS synthesizers of 2000 L and multiple 5000 L [LPPS] reactors as future modules come online. This allows us to scale responsibly and in line with customer needs.” R&D headcount is also expected to grow at a double‑digit rate this year, and the manufacturing team will more than double to support the ramp‑up. This complements Neuland’s existing 1,174,000 L of API manufacturing capacity across three US FDA– approved facilities, which are supported by a large, dedicated R&D Centre located in close proximity. This integrated setup enables seamless scale up, rapid tech transfer, and highly efficient development-tocommercial execution. “Building on the strength of our reputation among innovator and biotech customers for complex API capabilities, this new facility marks our strategic entry into commercialscale peptide manufacturing”, added Davuluri. “A key part of our strategy will be to first support innovator and emerging biotech companies across all areas of novel peptide development, as well as the ongoing demand for GLP-1 manufacturing. We see commercial peptide production as a key growth driver for the business over the coming years. So we are now scaling rapidly and expect to rollout all modules of the new peptide facility in line with customer demand .” This latest news follows on from an impressive few years for the CDMO, as multiple NDAs have been filed on behalf of customers recently, with several more filings expected over the next two years, reinforcing its strong regulatory track record in supporting commercial supply. Additionally, Neuland’s LPPS capabilities provide secure supply of peptide building blocks, fragments, intermediates, and hybrid constructs—strengthening supply‑chain resilience for complex peptides. The newly completed plants will feature advanced digital operation systems – controlled through DCS-based automation with eBMR integration – and scalable peptide technologies across synthesis, purification and drying. The facility includes expanded downstream capabilities: multi‑column prep‑HPLC systems, lyophilizers and dryers sized for commercial campaigns, enhanced solvent‑handling and tank‑farm infrastructure, dedicated warehouses, and upgraded waste‑management systems supporting high‑volume operations. The systems are designed to support data-rich process development, reduced batch variability and improved cycle times. Reference 1. Upto INR 500 crore will be spent depending on customer demand. Neuland to open commercial peptide facility as part of planned phased expansion The CDMO’s Module 1 commercial production facility to be operational by summer 2026 NEWS
15 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026 NEWS Shilpa Biologicals and mAbTree Biologics secure orphan drug designation from U.S. FDA Marks significant milestone for breakthrough biologic to treat rare blood cancers Shilpa Biologicals, part of the Shilpa Medicare Group, together with mAbTree Biologics AG, announce a major regulatory milestone as the U.S. Food and Drug Administration (FDA) grants Orphan Drug Designation (ODD) to their flagship breakthrough biologic, an investigational monoclonal antibody being developed for the treatment of Essential Thrombocythemia (ET) and Polycythemia Vera (PV) – rare, chronic blood cancers with significant unmet medical need. This novel checkpoint inhibitor may also have potential in additional cancer indications, including lung cancer and head and neck squamous cell carcinoma. Securing Orphan Drug Designation recognizes both the seriousness of ET and PV and the potential of this first-in-class, immunology-driven biologic to modify disease progression rather than only managing symptoms. It also provides regulatory and commercial incentives, including development support, tax credits, and market exclusivity upon approval. “This milestone marks a defining moment for Shilpa’s biologics journey and validates the strength of our collaboration with mAbTree Biologics,” said Dr. Sridevi, Chief Executive Officer of Shilpa Biologics Pvt. Ltd. “The FDA’s recognition of our flagship biologic underscores the quality of the science and our ability to translate innovation into globally relevant clinical programs. We are advancing rapidly toward clinical development and see strong potential beyond rare blood cancers.” Patients with ET and PV often require lifelong treatment. Existing therapies—including aspirin, interferon-alpha, hydroxyurea, and JAK inhibitors—have improved disease management; however, a significant proportion of patients become refractory or intolerant over time, reinforcing the need for therapies that directly address disease biology. “Receiving Orphan Drug Designation from the FDA is a strong validation of the differentiated mechanism behind this program,” said Raj Andhuvan, Chief Executive Officer of mAbTree Biologics AG. “By targeting immune dysregulation—now recognized as a central driver of disease persistence in myeloproliferative neoplasms— this biologic has the potential to establish a new therapeutic paradigm in rare blood cancers.” The investigational biologic targets a previously underexplored immuneevasion pathway implicated in Myeloproliferative neoplasms biology, offering the potential for durable disease control and a clearly differentiated clinical profile.Following this regulatory milestone, Shilpa Biologicals Pvt Ltd and mAbTree Biologics AG will advance the program through IND-enabling studies, with the objective of initiating first-inhuman clinical trials in patients with ET and PV. Shilpa Biologicals will attend BIO-Europe Spring 2026 in Lisbon from 23–25 March, where the company is expected to see strong interest from emerging biotech firms in its CDMO services, as it continues to expand its partner base across biologics discovery and development.
16 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026 WuXi XDC, a CRDMO specializing in antibody-drug conjugates (ADCs) and other bioconjugates, and Earendil Labs, a biotech company advancing biologics for the treatment of autoimmune diseases, cancer, and other conditions with unmet medical needs, announced a strategic collaboration on February 27th, 2026. The deal grants Earendil an exclusive global license to the WuXiTecan-2 payload-linker technology platform for use in its drug development program. In return, WuXi XDC will be eligible for up to approximately $885 million in upfront and milestone payments, as well as tiered royalties on net sales of any resulting products. According to a company press release, Earendil will use WuXi’s technology to conjugate antibodies and bispecific antibodies for multiple specific targets discovered through its AI platform. Additionally, WuXi XDC will support the CMC development and manufacturing of the ADC components within the collaboration, while Earendil will focus on subsequent product development, global regulatory submissions, and commercialization. “We are very pleased to establish this strategic partnership with Earendil Labs. This collaboration not only fully demonstrates the value of our WuXiTecan-2 payload-linker technology platform but also marks another significant milestone for WuXi XDC in empowering cutting-edge innovation alongside our partners,” said Jimmy Li, PhD, CEO, WuXi XDC, in the release. “Earendil Labs has generated bispecific antibodies with differentiated advantages using its unique AI platform. Combining these with our WuXiTecan-2 technology helps develop more effective and safer next-generation ADCs. We look forward to supporting Earendil Labs in accelerating the R&D and commercialization of their ADCs through our integrated, end-to-end CRDMO service platform, ultimately benefiting patients worldwide.” “Partnering with WuXi XDC represents a critical step in our mission to transform biopharmaceutical R&D through AI. WuXi XDC possesses a globally recognized and validated ADC technology platform and end-toend manufacturing capabilities,” said Jian Peng, PhD, CEO, Earendil Labs, in the release. “This collaboration is a powerful alliance between frontier AI exploration and WuXi XDC’s integrated CRDMO services. We eagerly anticipate working closely with WuXi XDC to drive innovative breakthroughs through technological integration, empowering high-quality development in the global biopharma industry and contributing to the health of patients globally.” “ADCs are emerging as a promising class of therapeutics in the treatment of cancer and many other human diseases,” said Zhenping Zhu, MD, PhD, President & co-CEO of Earendil Labs, in the release. “At Earendil Labs, we are developing a rich pipeline of bispecific / multispecific ADCs utilizing our cuttingedge AI and high-throughput biology [platforms]. We believe WuXiTecan-2 payload-linker technology will significantly enhance the success rate and speed of our novel ADC development, ultimately bringing these potentially life-transforming treatments to patients worldwide as soon as possible.” WuXi XDC strikes $885 million ADC deal with Earendil Labs NEWS Argo Biopharma appoints Dr. Gena Wang as CFO and CSO Argo Biopharma, a clinical-stage biotechnology company advancing next-generation siRNA therapies, announced the appointment of Dr. Gena Wang as Chief Financial Officer and Chief Strategy Officer on March 2nd, 2026. Dr. Wang joins Argo from Barclays, where she served as Managing Director,
17 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026 senior research analyst of Small and Mid-Cap Biotechnology. According to a company press release, Dr. Wang’s speciality lies in RNA therapies, cell and gene therapies, and emerging modalities in rare diseases and oncology. In addition to her eight-year stint with Barclays, Dr. Wang has also worked as a sell-side analyst at investment banks like Jefferies and Leerink Partners. She received her Ph.D in Molecular Biology from the State University of New York and conducted her postdoctoral training at the Rockefeller University; both programs focused on RNA research. “I am thrilled to join Argo Biopharma at such an important stage of its development,” said Dr. Wang in the release. “I have followed the evolution of RNA therapies for decades, and I believe Argo has developed a compelling, innovative siRNA platform to support potentially differentiated best-in-class assets across a wide range of important indications. I look forward to partnering with the management team to help Argo Biopharma achieve its long-term goals of delivering transformative therapeutics to patients while creating value for shareholders.” “We are excited to welcome Dr. Wang to our management team,” said Dr. Dongxu Shu, co-founder, Chairman of the Board, and CEO, Argo Biopharma, in the release. “Her deep knowledge of the genetic medicines landscape, expertise in biotechnology capital markets, and her reputation and strong relationships within the financial community and healthcare industry make her an invaluable addition as we continue advancing our pipeline and entering our next phase of growth. I look forward to working closely with Dr. Wang in her new role.” NEWS Teva Pharmaceuticals and Blackstone Life Sciences announce $400 million funding agreement for IBS candidate Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, and Blackstone Life Sciences (BXLS), a private life sciences investment company, announced a $400 million strategic funding agreement on March 3rd, 2026. Spread across the next four years, the funding agreement will support the continued clinical development of duvakitug, a monoclonal antibody Teva is developing as a potential treatment for ulcerative colitis (UC) and Crohn’s disease (CD), two of the most common forms of inflammatory bowel disease (IBD). According to a company press release, BXLS will be eligible for regulatory and commercial milestone payments concerning duvakitug, as well as low single-digit royalties on worldwide product sales. Duvakitug is a human monoclonal antibody designed to target TL1A, which investigators believe may play a role in amplifying inflammation and driving fibrosis associated with IBD. Phase IIb data evaluating duvakitug in UC and CD demonstrated clinically meaningful durable efficacy, according to the release, and the candidate is now being evaluated in a Phase III clinical trial. Teva is co-developing and co-commercializing duvakitug with Sanofi as part of a separate development agreement. “Today’s announcement highlights how we are turning strategy into action under Pivot to Growth,” said Evan Lippman, Executive Vice President, Business Development, Teva, in the release. “By pursuing disciplined, capital-efficient partnerships, we are accelerating pipeline advancement while maintaining financial strength. This is the model we will continue using to build a more innovative, resilient, and growth-oriented Teva.” “We are excited to partner with Teva and support their innovation priorities as they advance a critical new product to patients who have significant unmet need,” said Dr. Nicholas Galakatos, Global Head, Blackstone Life Sciences, in the release. “This transaction further demonstrates our focus on partnering with leading biopharmaceutical companies to execute their growth initiatives.” “Duvakitug has the potential to be a best-in-class therapy in a large and growing space, and the Teva and Sanofi teams are well positioned to develop and commercialize this important medicine,” said Paris Panayiotopoulos, Senior Managing Director, Blackstone Life Sciences, in the release. “In line with our mission, we are delighted to partner with Teva on their Pivot to Growth strategy and to help bring duvakitug to patients as soon as possible.”
18 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026 NEWS Axplora, a global leader in complex active pharmaceutical ingredient (API) manufacturing, today announced a major milestone in its $60 million investment programme at its Farmabios site in Gropello Cairoli. The latest phase includes construction of a new 4,500 m², three-storey R&D and laboratory hub, designed to accelerate development, expand execution capacity and deliver cost-efficient high-potency manufacturing at scale. The investment builds on recent expansions across the Axplora network, including the multi-millioneuro lyophilization expansion in Le Mans, France, strengthening the Group’s integrated ADC manufacturing platform. Once operational, the new facility will increase development and analytical throughput, reduce technology transfer complexity and compress timelines from early development to commercial production. HPAPI molecules now make up over 30 % of the global drug development pipeline, with over 1,000 highly potent small mole¬cules in development. The new facility will house state-ofthe-art R&D laboratories, Quality Control laboratories, Microbiology laboratories, and integrated support areas, directly connected to existing manufacturing operations. Colocating development, analytics and large-scale HPAPI production within a single specialised site eliminates multi-site delays, improves scaleup efficiency and enhances overall programme economics. Farmabios already operates one of Europe’s largest HPAPI manufacturing workshops, built to an OEB 5 containment strategy. The site has five independent manufacturing lines and 105 m³ of installed capacity, supporting batch sizes from 0.5 – 300 kilograms. This platform is fully operational today, enabling immediate execution of high-volume, high-potency programmes. Martin Meeson, Chief Executive Officer of Axplora, said: “This investment is about enabling our customers to quicker at scale to and through the clinic, to help them bring their products to patients sooner. As pharma pipelines consist of molecules of higher potency and additional complexity, customers are looking to avoid delays through fragmented supply chains. By expanding R&D, analytical and quality capabilities alongside large-scale HPAPI production, we are shortening development cycles and helping them control cost while accelerating time to market.” He added: “Axplora already manufactures 6 of the 14 FDAapproved commercial ADCs, and we continue to see strong momentum across ADC and other high-potency programmes. This expansion ensures we remain ahead of demand and fully aligned with the needs of innovators bringing next-generation therapies to patients.” Mario Di Giacomo, Managing Director of Farmabios, commented: “Our customers are increasingly looking to move quickly without compromising quality. This new R&D hub strengthens our ability to deliver integrated, endto-end programmes within a single site. By reducing complexity and avoiding unnecessary transfers, we improve both timeline predictability and overall programme costs.” Construction is underway, with completion targeted for February 2027. The underlying HPAPI manufacturing capacity supporting this growth is qualified and operational, with first projects under way. Biopharma’s growing emphasis on highly potent drugs drives Axplora manufacturing expansion Esperion Therapeutics inks $255 million deal to acquire Corstasis Therapeutics Esperion Therapeutics, a commercial-stage biopharmaceutical company advancing cardiometabolic and rare disease therapies, announced plans to acquire Corstasis Therapeutics, a company advancing treatments for heart failure, liver disease, and kidney disease, on March 3rd, 2026. Corstasis’ portfolio includes the recently FDA-approved Enbumsyt (bumetanide nasal spray), a nasal spray diuretic approved by FDA in September 2025 as a treatment for edema associated with congestive heart failure, as well as hepatic and renal disease, including nephrotic syndrome, in adults.
19 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026 According to a company press release, Costasis shareholders will receive an upfront payment of $75 million, as well as an additional $180 million in various regulatory and commercial milestones. Corstasis shareholders will also be eligible for low double-digit royalties on sales of Enbumsyt and follow-on products. The transaction is expected to close in Q2 2026. “This acquisition represents a compelling and strategically aligned opportunity that accelerates Esperion’s momentum and advances our long-term Vision 2040. Enbumyst brings meaningful innovation to millions of patients who continue to struggle with the daily burden of diuretic therapy. Enbumsyt’s novel intranasal delivery, established regulatory approval, and expanding clinical footprint make it a natural fit for our cardiovascular franchise,” said Sheldon Koenig, President and CEO, Esperion, in the release. “We expect that by integrating Enbumyst into our proven commercial platform, we will drive sustained double-digit growth, strengthen our leadership in cardiovascular care, and create durable value for all of our stakeholders - from patients and providers to employees and shareholders.” “Enbumyst was purpose-built in partnership with the cardiology community to address a clear unmet need. Today’s acquisition validates our team’s vision and approach,” said Ben Esque, CEO, Corstasis Therapeutics, in the release. “We are excited about the future of Enbumyst in Esperion’s hands and its ability to intervene in the patient setting to treat worsening heart failure at home.” NEWS Glenmark Generic inhaler receives FDA nod Glenmark Pharmaceuticals, a global pharmaceutical company focused on innovation and accessibility, announced FDA approval for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation, on March 4th, 2026. According to a company press release, FDA granted the treatment a Competitive Generic Therapy (CGT) designation, meaning the agency considers it to be bioequivalent and therapeutically equivalent to GSK’s FloVent. According to IQVIA sales data cited in the release, FloVent achieved annual sales of approximately $520.1 million for the 12-month period ending in January 2026. Due to its CGT designation, Fluticasone will receive 180 days of CGT exclusivity upon commercialization. The company expects to begin U.S. distribution later this month. “Receiving approval for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation marks an important milestone in strengthening our respiratory portfolio in the U.S. The CGT designation and first approved applicant status reflect the technical expertise and dedication of our teams in bringing complex inhalation therapies to market,” said Marc Kikuchi, President & Business Head, North America, Glenmark Pharmaceuticals, in the release. “We remain committed to improving access to quality and affordable respiratory treatments for patients and healthcare providers.” SUBSCRIBE TO OUR: NEWSLETTER PRINT MAGAZINE DIGITAL MAGAZINE
NEWS Johnson & Johnson announced FDA approval of Tecvayli (teclistimab-cqyv) plus Darzalex Faspro (daratumumab and haluronidase-fihj) as a treatment for relapsed or refractory multiple myeloma (RRMM) on March 5th, 2026. The treatment is indicated for patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, according to a company press release. FDA approval was based on results from MajesTEC-3, a Phase III clinical trial evaluating teclistamab plus daratumumab versus investigator’s choice of daratumumab and dexamethasone with either pomalidomide or bortezomib in patients with RRMM who have received at least one prior line of therapy. The study found that patients treated with teclistamab plus daratumumab had an 83% reduction in the risk of disease progression or death compared to the cohort given the traditional standard of care. Significant improvements were also observed in secondary endpoints like treatment response rates, minimal residual disease-negativity, overall survival, and time to worsening of symptoms, according to the release. “This new treatment option can redefine how we approach RRMM treatment by giving healthcare providers a regimen with improvement in PFS and OS and a well-characterized safety profile,” said Dr. Luciano J. Costa, Professor of Multiple Myeloma and Director of the Multiple Myeloma Research and Treatment Program, University of Alabama at Birmingham, and Primary Investigator of MajesTEC-3, in the release. “The option to use this regimen as early as second line is particularly important because patients with RRMM often experience multiple relapses and reduced responsiveness to therapy over time, which makes earlier treatment with the most effective therapies critical. In addition, the steroid-sparing approach may reduce toxicity and improve tolerability.” “As the leader in hematology, we have a proud history of transforming the treatment landscape for multiple myeloma. This approval represents another pivotal milestone in improving outcomes for patients living with this disease, with a unique regimen accessible to patients across all practice settings,” said Imran Khan, M.D., Ph.D., Vice President, U.S. Hematology Medical Affairs, Johnson & Johnson. “The FDA approval of [teclistamab plus daratumumab] adds a powerful new treatment option to our multiple myeloma portfolio, moving us closer to our ambition of one day curing this disease.” Teclastamab is a first-in-class, bispecific T-cell engager antibody therapy designed to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. Prior to this approval, it received accelerated approval from FDA in October 2022 as an off-the-shelf treatment for patients with RRMM who received at least four prior lines of therapy, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody. FDA approves Johnson & Johnson second-line multiple myeloma treatment REDEFINING PUBLISHING STANDARDS. WE ARE EXTRA-ORDINARY
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