1 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 WELCOME ELLIE BRUNI Publishing Director TWENTYFOURSEVENBIOPHARMA When I meet with industry colleagues at the various conferences that fill the schedule, there is a question I often pose: in 2025, what is the story of life sciences? Today, I want to share some of the responses I get, which tend to fall into one of three buckets. First are the market-minded folks, who tend to point to investor uncertainty within the life sciences market. The trajectory of the biggest deals is illustrative of their anxieties; at the time of writing, Johnson & Johnson’s $14 billion acquisition of Intra-Cellular Therapies headlines this year, but fails to surpass any deal from the prior three years. ($16.5 billion in 2024, $43 billion in 2023, and $27.8 billion in 2022.) While the scale of the industry’s largest deals is not necessarily indicative of its overall health, it does speak to the broader concerns surrounding bio/pharma asset evaluations and an undercurrent of uncertainty in the global markets. In a somewhat similar vein, others think of the life sciences industry in relation to current geopolitics, pointing to the reshifting of the industry amid U.S. tariffs, demands for drug pricing reform, and a looming trade war with China. The United States has recently dabbled in pricing reform with the Inflation Reduction Act, but the current administration is threatening additional trade barriers to companies that refuse to lower prices in the country. For many companies, retaining access to the lucrative U.S. market will require some combination of reshoring, raising prices, and/or accepting a hit to profit margins. Pfizer’s recent deal is one such example, exempting them from three years of tariffs in exchange for lower prices and promised manufacturing investment in the U.S. The last mindset focuses on advances in the sciences. GLP-1s come up often, which is natural given that the market is expected to grow to $471.10 billion by 2032. Strides in oncology also continue to be made, including double-digit approvals from FDA for novel cancer treatments. And while many are beginning to grow wary of a speculative bubble, AI/ML is showing promise in both R&D and as a preliminary diagnostics tool for patients. Allow me to pose the question once more, this time to you, dear reader. In 2025, what is the story of life sciences? 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 2025. 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 3 / October 2025 SUNRESIN 54 Innovation in SPPS: A new MBH Br resin for manufacturing C-terminal acid peptides, an alternative to Wang and CTC resins SYNGENE 58 Translational and clinical integration is reshaping early-phase drug development HAS-CERBIOS 60 Inside HAS-Cerbios: Building a unique CDMO FLAMMA 64 Why innovator companies need to take control of their supply chains CONTENTS 1 WELCOME NEWS 4 VERANOVA 34 Realizing the potential of ADCs DIGITALISATION 38 Resilient, digital, diversified: The pharma supply chain of 2030 GRIFOLS 42 Interview LONZA 46 Data-driven drug development: Accelerating small molecule success in early phase AXPLORA 50 Mastering complexity - Innovative strategies for efficient ADC payload manufacturing and bioconjugation MARTA SERRA Quality & Regulatory Director GRIFOLS GRIFOLS Interview 42
3 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 CONTENTS PROCOS SpA 66 Interview CPHI FRANKFURT 70 CPHI personal stories roundtable PHARMATECH ASSOCIATES 76 Predictive modelling: the new imperative for pharmaceutical innovation SONIA RASI Financial Director 66 PROCOS SpA Interview PATRICIA LUHRS Client Services & Account Manager CLARA USANNA Senior Sales Manager – Europe, Latam, Africa, India & Oceania ADRAGOS PHARMA 82 The importance of ioequivalence studies for successful new generics BIOTECH 86 Military sponsored trials rowth is picking up the slack of weak VC funding – with non-military applications quickly emerging
4 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 NEWS Almac Group has completed a multi-million-pound expansion of its bioavailability enhancement capabilities at its facility in Charnwood, UK. The significant investment by Almac Pharma Services, will address ongoing industry challenges around solubility and growing global demand for advanced formulation solutions. The investment includes the installation of Buchi S300 and GEA PSD1 closed-loop spray drying technology and extensive expansion of the facility’s analytical laboratories. This new technology, coupled with existing liquid capsule filling and non-sterile oral liquid formulation solutions at the facility, widens Almac’s bioavailability enhancement capability. The new technologies’ containment capabilities also complement existing potenthandling capabilities at the site. This latest clinical investment expands on Almac’s longstanding pre-clinical expertise in bioavailability and amorphous solid dispersion development using a range of technologies including spray drying and melt extrusion. Almac also offers advanced particle engineering technologies and supporting analytical capabilities. This expansion of market-leading technologies and expertise across Almac’s scientific teams now bridges the gap between pre-clinical and clinical drug development and gives clients even greater access to a range of advanced formulation approaches. This results in delivering a faster route to market for our clients, improved therapeutic performance and ultimately better patient outcomes. James Hurst, VP Operations and Charnwood Site Head, Almac Pharma Services said: “This investment is a direct response to the growing demand for sophisticated formulation solutions. Spray drying is a cornerstone technology for enabling next-generation therapeutics, and our expanded capabilities ensure we remain at the forefront of pharmaceutical innovation. Our clients trust us to deliver precision, speed, and scientific excellence – this investment reflects our ongoing commitment to supporting clients with advanced technologies and expertise that drive success.” This latest announcement builds upon the Group’s £11m investment in global analytical capabilities and comes just months after Almac Pharma Services officially opened its 100,000 square foot commercial manufacturing facility at its global headquarters in Craigavon, Northern Ireland. The £65 million facility further strengthens Almac’s end-to-end service offering, reinforcing the company’s ongoing commitment to expanding capacity, advancing technological innovation, and supporting clients worldwide with industry-leading pharmaceutical development and manufacturing solutions. Almac Group expands bioavailability enhancement capabilities Addressing a critical need in drug development Symeres, a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announces the acquisition of DGr Pharma, a drug development-focused consultancy, to expand its integrated earlystage drug development services and accelerate IND-enabling capabilities for biopharma clients. The acquisition is supported by Keensight Capital (“Keensight”), one of the leading private equity managers dedicated to pan-European Growth Buyout investments. Founded in 2018 and based in the Netherlands, DGr Pharma specialises in pre-clinical and Symeres acquires DGr Pharma to enhance regulatory expertise and broaden its biopharma capabilities
5 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 clinical regulatory strategy and consultancy for biotech and pharmaceutical partners working in early drug development. Its core services include chemicalpharmaceutical, non-clinical and clinical development planning, quality assurance, and regulatory submissions. DGr Pharma has deep expertise in small and large molecules including antibodies, ADCs and oligonucleotides. With a reputation for scientific rigor, DGr Pharma adds significant regulatory depth to the Symeres portfolio enabling it to deliver a more integrated solution across the full spectrum of drug discovery and development. DGr Pharma’s pharmacokinetic data analysis services operate under Good Clinical Pratice (GCP) and Good Laboratory Practice (GLP), expertise that aligns with Symeres’ integrated offering, including ADME. The GLP status enhances data quality and regulatory readiness, giving Symeres’ clients a more efficient and reliable path to IND submission. Guillaume Jetten, CEO of Symeres, commented: “This acquisition strengthens our ability to offer truly integrated solutions across the drug discovery and development spectrum. The company enhances our scientific capabilities, allowing us to better support our clients’ evolving needs and reinforce Symeres’ position as a partner of choice in the global biopharma market.” Kees Groen, Founder and CEO of DGr Pharma, added: “This is an exciting new chapter for DGr Pharma. Joining Symeres provides us with the opportunity to grow our reach and expand the value we bring to clients, particularly in early-stage development. We share Symeres’ commitment to high-quality science, long-term relationships and entrepreneurial ambition and we look forward to being part of the next phase of growth.” Amit Karna, Partner at Keensight Capital, concluded: “We are proud to support Symeres with this specialized acquisition, which will extend the company’s capabilities into highly complementary services and attractive drug classes. We look forward to continuing to support the Symeres team as they selectively broaden the Company’s offering for their blue-chip biopharma clients.” NEWS
6 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 Chrysalis, a leading GMP cleanroom hosting and support services partner for advanced therapy and biopharma innovators, is pleased to announce the appointment of Adam Bartley as its Chief Operating Officer (COO). In this role, Bartley will lead day-today operations and growth across Chrysalis’ cleanroom infrastructure, environmental monitoring, and support service teams. He joins the executive team as Chrysalis strengthens its operational capabilities to support an expanding portfolio of advanced therapy clients. Bartley brings over 24 years of leadership experience in biopharmaceutical operations. Over the course of his career, Adam has contributed to the success of globally NEWS FUJIFILM Biosciences, a global leader in the innovation and manufacture of cell culture solutions for the Life Science market, today announced the commercial launch of BalanCD HEK293 Perfusion A. Designed to expand and augment the company’s portfolio of gene therapy application solutions, BalanCD HEK293 Perfusion A uses suspension HEK293 cells and perfusion technology to provide reliable, efficient, and scalable production of viral vectors for development of gene therapies. HEK293 cells are well established for gene therapy applications in upstream bioprocessing, offering reliable growth rates, high transfection success and expression of cellular factors needed for virus replication. BalanCD HEK293 Perfusion A further enables process optimization by maximizing cell growth, viability, and productivity, and supporting a wide range of applications including viral vector production, transient protein expression, and recombinant protein production. This medium is designed for high density perfusion culture with demonstrated compatibility across a variety of cell retention devices giving it broad versatility across workflows, and is available in a variety of media package options for continuous processing and optimal performance. The BalanCD HEK293 Perfusion A medium is compatible with different types of transfection methods, and suited for both steady-state and intensified perfusion processes. The new product harnesses the benefits of perfusion technology to enable a reduction in overall capital expenditures associated with AAV and LV production - key virus types for in vivo and in vitro gene transfer. Together, it can help maximize resources for consistency and scalability while providing clinicalquality, high-performing media that can support large-scale commercial batch sizes for advanced therapy development. “FUJIFILM Biosciences is committed to helping our partners bring innovative new treatments and therapies to more patients than ever before. With BalanCD HEK293 Perfusion A medium, we have introduced a new way to advance gene therapies, building on a family of purposely-designed, high performing HEK293 products to provide more consistent, high-quality resources across the treatment spectrum,” said Erik Vaessen, Chief Business Officer, FUJIFILM Biosciences. “This innovative approach is another example on how we are customizing services, products, and systems to help all who bring therapeutics to more patients, as we continue to work on this mission together.” FUJIFILM Biosciences introduces BalanCD HEK293 Perfusion A Medium to enable gene therapy production Chrysalis appoints Adam Bartley as Chief Operating Officer
7 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 recognized companies including Wyeth, Shire, and Sanofi, where he gained deep expertise in advancing innovative therapies and supporting organizational growth. Most notably, he joins Chrysalis not just as an industry veteran, but as a former client, having previously partnered with the company to launch and operate cleanroom-based manufacturing operations at Editas Medicine. “Adam’s deep operational and leadership experience is only strengthened by his unique understanding of our Chrysalis operating model,” said Sarah Stevens, CEO of Chrysalis. “He’s lived our customer experience first-hand, and brings a pragmatic, continuous improvement mindset that complements our ability to enable speed, quality, and flexibility for our customers.” As a former Senior Vice President of Business Operations at Editas Medicine, Bartley led programs through tech transfer and facility startup, while leveraging the Chrysalis’ cleanroom and support infrastructure. His experience as a customer will further strengthen our service delivery and growth. “As a client, I saw the value Chrysalis brings to growing biotechs – cutting out complexity and significant capital expenditure so teams can focus on science and execution,” said Bartley. “I’m excited to now be on the inside, helping scale that model and push operational boundaries to support even more clients.” Bartley’s appointment reflects Chrysalis’ continued investment in people and operational excellence as it expands its support of biopharma clients from development through GMP clinical and commercial production. Quotient Sciences, a leading global drug development and manufacturing accelerator, and UK technology innovation centre, CPI, have signed a memorandum of understanding (MoU) to form a Joint Venture (JV) aimed at accelerating the development of RNA-based therapies. The JV will combine Quotient Sciences’ Translational Pharmaceutics® platform with CPI’s expertise in small scale manufacture of RNA and LNP encapsulation to deliver a firstof-its-kind, integrated offering for the development of mRNA drug products. The JV will address the growing industry demand for agile solutions that bring new RNA therapeutics to patients with greater speed and confidence. “This is a pivotal moment for RNA drug development,” said Thierry Van Nieuwenhove, CEO at Quotient Sciences. “The combined innovation and deep technical expertise of Quotient and CPI will enable developers to benefit from a vastly accelerated supply chain, with clinical batches going from plasmid to clinical dose in as little as two months. This offers a highly streamlined pathway to early-phase clinical trials for mRNA drug candidates”. The JV will integrate mRNA synthesis, LNP formulation development, clinical manufacturing, and early-phase clinical testing, all under one collaborative framework. The ability to quickly transition from DNA to RNA and into clinical trials will not only shorten timelines but also greatly increase the chances of clinical success, by affording drug developers the ability to adjust dose and formulation parameters based real-time clinical data from healthy human volunteers. This approach offers clear advantages in modalities where drug delivery is key to efficacy. Frank Millar, CEO at CPI, added: “We’re proud to be partnering with Quotient Sciences on this initiative which represents a bold step forward for the RNA ecosystem. Our shared vision is to enable scalable and sustainable development pathways for mRNA therapies that meet global health challenges head-on.” Translational Pharmaceutics® has been used globally by biotech and large pharma on over 500 programs with small molecule and peptide drug candidates. This JV extends the application of Translational Pharmaceutics into mRNA-based therapeutics. Details of the joint venture including name, branding, and operational roadmap will be announced as the collaboration progresses. Quotient Sciences and CPI to accelerate RNA drug development with joint venture NEWS
8 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 NEWS Abzena, the leading end-to-end integrated CDMO for complex biologics and bioconjugates, announced the expansion of its AbZelectPRO™ cell line development (CLD) platform with the launch of two next-generation Glutamine Synthetase (“GS”) knockout CHO-K1 expression systems, including a double knockout ADCC+ platform for afucosylated proteins. The addition of the new GS knockout cell lines will further enhance speed, scalability, and flexibility for biopharma customers. Named AbZelectPRO™-KO and AbZelectPRO™-KO+, the new GS knockout platforms are available as a standalone CLD offering or as a fully integrated GMP program, with fully transparent pricing to IND with no royalty fees. This flexible offering will enable customers to select a CLD strategy that aligns with their projectspecific goals, timeline, and budget. Campbell Bunce, CSO of Abzena, said, “At Abzena, we consistently strive to build stronger partnerships with our customers by offering them innovative solutions and technologies that meet their needs across the drug development supply chain. The addition of these new GS knockout cell lines to our AbZelectPRO™ CLD platform is a powerful combination that truly sets a new standard of excellence. We are thrilled to offer such a robust, scalable, and state-of-the-art offering to support our customers’ therapeutic antibodies and difficult-to-express proteins.” Licensed from Revvity, both GS knockout CHOSOURCE™ expression systems have been integrated into the AbZelectPRO™ CLD workflow and paired with ProteoNic Bioscience’s 2G UNic® next-generation vector technology. This unified approach has been proven to significantly enhance productivity and flexibility, enabling biopharma customers to quickly transition from DNA to research cell banks (RCB) in 10 weeks, with highperforming titers of up to 10g/L. “We are proud that our 2G UNic® vector technology continues to deliver premium performance within Abzena’s AbZelectPRO™ platform. ProteoNic’s technology boosts productivity in CHOSOURCE™ and other cell lines and strengthens the value of this offering for biopharma customers,” said Frank Pieper, CEO of ProteoNic. Bryan Kipp, SVP Technology & Licensing, Revvity said, “At Revvity, we tell customers that when they work with us, they should expect more — more collaboration, more breakthroughs, and more impact. What excites me most about Abzena’s new expanded cell line development platform, inclusive of Revvity’s well-established CHOSOURCETM cell lines, is that it directly targets ongoing major challenges for customers, enhancing productivity and flexibility. Ultimately, Abzena’s approach will lead to a greater impact for customers, which is a common passion we share and support.” Revvity’s proprietary CHOSOURCE™ Glutamine Synthetase (GS) knockout cell line is an industry standard, cGMPmanufactured CHO-K1-derived suspension cell line. It has been referenced in over 90 IND filings and is currently featured in four approved drugs on the market. Revvity’s CHOSOURCE™ ADCC+ (Antibody Dependent Cellular Cytotoxicity) cell line is a double knockout of both the glutamine synthetase (GS) & fucosyltransferase genes. Abzena enhances AbZelectPRO™ cell line offering with new GS knockout platforms Symbiosis Pharmaceutical Services (Symbiosis), a global contract manufacturing organisation (CMO) specialising in the sterile manufacture of injectable drug products, has appointed Wendy Cook as a Qualified Person (QP) to further strengthen its regulatory and quality leadership team. Wendy brings more than 20 years of pharmaceutical quality assurance experience across GLP, GCP and GMP environments, with experience in sterile manufacturing and clinical trial supply chains. Since qualifying as a QP in 2018, she has held roles at both CDMOs and global CMOs, where she oversaw batch certification, regulatory submissions and quality oversight across multiple dosage forms including sterile injectables. Commenting on her appointment, Wendy said: “Symbiosis has built Symbiosis expands quality leadership with new qualified person appointment
9 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 Inizio appoints Ryan Quigley as its new Chief Executive Officer to lead its next phase of growth The board of Inizio, a leading commercialization partner to health and life sciences companies globally, has announced today the appointment of Ryan Quigley as Chief Executive Officer, effective 9 September 2025. Ryan succeeds Paul Taaffe, who will continue to work with Ryan to support the transition until the end of the year. Ryan has served as Inizio’s Chief Operating Officer since 2021, driving the company’s commercial strategy, innovation agenda, and investment roadmap, as well as playing a pivotal role in developing Inizio into the leading commercialization partner to health and life sciences companies globally. With $1.6bn in revenue and more than 10,500 employees across five connected business units, Medical, Advisory, Evoke, Engage and Biotech, Inizio partners at scale with more than 700 large pharma and biotech clients globally to support their clinical development and commercialization journeys, improving patient access and experience. Inizio brings a fully connected suite of technologyenabled capabilities, combined with specialized scientific expertise across all therapeutic areas, to support clients through every pivotal moment of their asset’s lifecycle, maximizing asset potential and impact, and enhancing treatment outcomes. Prior to being appointed to his current role, Ryan’s 25-year career spanned some of the world’s largest healthcare and pharmaceutical companies. Most notably, he held senior leadership roles at Abbott and AbbVie, where he was responsible for launching blockbuster brands across major markets. Ryan said: “This is an exciting time to lead Inizio as we continue to grow and help biopharma clients with integrated solutions to bring highly complex new drugs to market. At Inizio, it’s the combination of our people and our expertise that makes the difference: we connect talent from across the organization to create innovative solutions that make a meaningful difference for our clients and patients. Together, we will continue to unlock new opportunities, reimagine how healthcare engages with patients, professionals and society, and build on the momentum we have achieved over the last few years.” Liam FitzGerald, Chairman of the Board, said: “Ryan has an exceptional track record as a leader who combines strategic vision with deep operational expertise. He embodies the values of Inizio and has the energy, ambition and client focus to lead the business into its next chapter of growth and success.” “I would like to thank Paul personally and on behalf of the Board of Directors for his contribution to the successful development of Inizio as its CEO. He oversaw the creation of the company and built a market leader well positioned for sustained growth. Paul will remain closely involved with Inizio as a board member going forward.” NEWS a reputation for excellence in sterile manufacturing and regulatory compliance. I look forward to supporting clients in bringing their innovative therapies to patients quickly, safely and in full compliance with GMP.” The appointment follows Symbiosis’ successful MHRA inspection of its new 20,000 sq ft GMP facility, which recently added a state-ofthe-art automated sterile fill/finish line to the company’s commercial capabilities. This latest regulatory milestone reinforces Symbiosis’ robust compliance track record with both the MHRA and FDA. Nicola Paterson, Lead QP at Symbiosis, said: “Wendy’s appointment strengthens our QP team at a pivotal time for Symbiosis. Her knowledge of GMP, regulatory expectations and sterile manufacturing adds significant expertise to our quality leadership. Combined with our recent regulatory approvals, Wendy’s arrival underlines our commitment to delivering world-class regulatory support and compliant, flexible access to sterile manufacturing capacity for our clients. By expanding its QP and quality leadership team, Symbiosis continues to enhance its ability to help global biopharmaceutical companies navigate complex regulatory requirements while ensuring the reliable, timely delivery of life-saving injectable therapies.
10 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 NEWS Novo Nordisk today announced a company-wide transformation to simplify its organisation, improve the speed of decision-making, and reallocate resources towards the company’s growth opportunities in diabetes and obesity. As part of the transformation, Novo Nordisk intends to reduce the global workforce by approximately 9,000 of the 78,400 positions in the company, with around 5,000 reductions expected in Denmark. The transformation reflects the Company’s commitment to meet rising global demand while also competing in a more dynamic and consumer-driven obesity market, as evidenced by the recent slowdown in growth. Over the past years, Novo Nordisk’s rapid scaling has increased organisational complexity and costs. The transformation aims at addressing that complexity, so Novo Nordisk can invest more behind its science, commercial capabilities and manufacturing ramp-up – aiming to reach the millions of people who remain untreated. Mike Doustdar, Novo Nordisk president and CEO, said: “As the global leader in obesity and diabetes, Novo Nordisk delivers life-changing products for patients worldwide. But our markets are evolving, particularly in obesity, as it has become more competitive and consumer-driven. Our company must evolve as well. This means instilling an increased performance-based culture, deploying our resources ever more effectively, and prioritising investment where it will have the most impact – behind our leading therapy areas.” Investment priorities, timing and further initiatives The workforce reduction is expected across the Company, including staff areas and headquarters functions, and is expected to deliver total annualised savings of around DKK 8 billion by the end of 2026. The savings will be redirected to growth opportunities in diabetes and obesity, including commercial execution initiatives and R&D programmes. The implementation will begin immediately, and the Company expects to communicate with affected employees over the next few months, pending negotiations as per local legal labour market requirements. Further, additional initiatives are to be implemented to enhance organisational focus, performance culture and speed of decision-making as well as cost efficiencies. Novo Nordisk President and CEO Mike Doustdar added: “It is always difficult to see talented and valued colleagues go, but we are convinced that this is the right thing to do for the long-term success of Novo Nordisk. We need a shift in our mindset and approach so we can be faster and more agile. Our transformation plan is designed to deliver this. By realigning our resources now, we will be able to prioritise investments to drive sustainable growth and future innovation for the millions of patients with chronic diseases globally, particularly in diabetes and obesity.” One-off financial implications The company-wide transformation comes with an expected DKK 8 billion in net one-off restructuring costs, including impairment charges. Restructuring costs of around DKK 9 billion will be incurred in the third quarter of 2025, countered by savings of around DKK 1 billion in the fourth quarter. Consequently, Novo Nordisk expects an estimated one-off negative impact of around 6 percentage points on full-year operating profit growth at CER in 2025 compared to the operating profit outlook issued 6 August. This change in expectations for 2025 only factors in the one-off restructuring costs described above. The forward-looking statements section on page 26 in the Financial report for the first six months of 2025 (Company Announcement No 20/2025) also apply to this company announcement. Novo Nordisk’s disclosure of the financial results for the first nine months of 2025 and financial outlook for 2025 will be published on 5 November. Novo Nordisk to streamline operations and reinvest for growth
11 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 CONTENTS
12 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 FUJIFILM Biotechnologies, a worldleading contract development and manufacturing organization for biologics, vaccines, and advanced therapies, announced a significant expansion of its global partnership with argenx SE, a global immunology company. As part of the expanded agreement, FUJIFILM Biotechnologies will initiate manufacturing of argenx’ drug substance for efgartigimod at the Holly Springs, North Carolina, site in 2028. argenx is the first announced tenant in FUJIFILM Biotechnologies’ Phase II expansion in Holly Springs, which will add 8 x 20,000-liter (L) mammalian cell culture bioreactors to the site’s existing 8 x 20,000 reactors. Efgartigimod is a monoclonal antibody (mAb) fragment that targets the neonatal Fc receptor (FcRn) in patients with severe autoimmune disease. It is approved globally (as VYVGART® and VYVGART® Hytrulo) for the treatment of adults with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) – both chronic autoimmune neuromuscular diseases characterized by significant muscle weakness. With the expanded global manufacturing agreement, argenx will benefit from FUJIFILM Biotechnologies’ global kojoX™ network, which provides local-forlocal supply, manufacturing in close proximity to patients. Through kojoX, the industry’s largest interconnected modular network, FUJIFILM Biotechnologies offers flexible capacity at clinical and commercial scales from its manufacturing sites in United States, United Kingdom, Denmark, and FUJIFILM Group’s site in Japan. “This partnership with argenx marks our first global end-to-end program in support of a customer utilizing our kojoX modular network of facilities. By expanding manufacturing in the United States, we will help to meet argenx’ global supply chain needs for efgartigimod,” said Lars Petersen, president and chief executive officer, FUJIFILM Biotechnologies. “We are honored to support the manufacturing of this lifeimpacting therapy to supply to patients in need.” “Our expanded partnership with FUJIFILM Biotechnologies at its Holly Springs site adds to our existing U.S. manufacturing footprint and further strengthens our global supply chain,” said Filip Borgions, chief technology innovation officer, argenx. “The kojoX concept enables consistent capabilities across the U.S. and Europe, allowing us to manufacture medicines in the U.S. for American patients while supporting our broader global reach. We’re excited to partner with the FUJIFILM Biotechnologies team to unlock the full potential of the kojoX platform.” “Our kojoX manufacturing approach provides our global biopharmaceutical partners with the flexibility and agility to strengthen supply chain resilience, supporting a seamless delivery of critical therapies to patients worldwide,” added Petersen. FUJIFILM Biotechnologies expands strategic partnership with argenx to include U.S. manufacturing operations NEWS
Avid Bioservices, Inc., a leading biologics contract development and manufacturing organization (CDMO), today announced the appointment of Kenneth Bilenberg as its new Chief Executive Officer (CEO). A seasoned industry executive with more than 20 years of experience, Bilenberg most recently served as Chief Operating Officer of Fujifilm Biotechnologies, leading global operations across modalities and scale, and prior to that held senior leadership roles at Novo Nordisk. He is currently based in Denmark and will be relocating to California when possible. He succeeds Nick Green, who is stepping down for health reasons after guiding Avid through a period of strong growth. “Throughout this process, it was important to me to help identify the right leader to advance Avid into its next chapter,” said Green. “In Kenneth, we found someone with key industry experience as well as a strong vision and a true appreciation for Avid’s culture. I am confident the company is in excellent hands.” “The board of directors is delighted to welcome Kenneth Bilenberg as our new CEO,” the board said in a statement to staff. “Kenneth brings deep expertise in scaling organizations and delivering complex programs across international markets, which makes him an ideal choice to lead Avid into the future. We also extend our deepest gratitude to Nick Green for his visionary leadership, which has enabled significant growth, advanced capabilities, and a culture of excellence that will endure.” “Few companies stand out the way Avid does for its quality, regulatory track record, and delivery performance — always keeping patients, clients, and people at the center,” said Kenneth Bilenberg. “It is an honor to join Avid and to contribute to its vision of becoming a global leader in biomanufacturing solutions. Whether enabling predictable pathways from DNA to IND, advancing to BLA and commercial readiness, or supplying therapies at scale, Avid is well positioned to deliver for clients worldwide.” “Together with the Avid team, we will build on this strong foundation with a focus on predictability, trust, and exceeding client expectations. My nearterm priorities include: - Continuing predictable and strong delivery for existing clients - Supporting global biopharma reshoring and regional supply strategies - Expanding Avid’s capacity to meet growing worldwide demand Longer term, Avid’s foundation — supported by GHO and Ampersand’s life sciences portfolio — makes this one of the most exciting opportunities in the industry. From concept to commercialization, we are committed to helping our customers bring the most complex biologic therapies to patients across the globe.” Under Bilenberg’s leadership, Avid is poised to build on its foundation, expand its capabilities, and thrive as a trusted partner in advancing biologics to patients worldwide. Avid Bioservices welcomes Kenneth Bilenberg as new CEO NEWS
NEWS AGC Pharma Chemicals, a global CDMO specializing in Active Pharmaceutical Ingredients (APIs) and intermediates, with facilities in Spain (Barcelona) and Japan, today inaugurated its new state-of-the-art manufacturing plant in Malgrat de Mar, Barcelona, representing an investment of over 100 million euros. The new facility marks a key milestone in the company’s growth strategy and its long-term commitment to developing life-saving therapies, especially in oncology and other high-potency therapeutic areas. It represents a 30% increase in the company’s production capacity and introduces a segment dedicated to highly potent active ingredients (HPAPI). This strategic expansion strengthens the company’s long-term commitment to innovation, sustainability, and research, and will serve as a catalyst for the socioeconomic development of Catalonia by creating qualified job opportunities and attracting scientific and industrial talent. It also reinforces Catalonia’s position as a global leader in the pharmaceutical and healthcare sectors. The official opening ceremony took place this morning and featured speeches from AGC Pharma Chemicals CEO Jun Kurihara and AGC Inc. CTO Hideyuki Kurata, along with distinguished guests such as Akiko Shikata, Consul General of Japan in Barcelona; Sonia Viñolas, Mayor of Malgrat de Mar; and Miquel Samper, Minister of Business and Employment of the Government of Catalonia. In his inaugural speech, CEO Jun Kurihara highlighted the importance of the new plant: “This facility is more than a building: it is a symbol of our commitment to health, innovation, and sustainability. With this expansion, we increase our production capacity and reinforce our mission to improve people’s lives through the highest quality pharmaceutical manufacturing. We are deeply grateful for the support of institutions and our team, and proud to do this here in Catalonia.” Mayor Sonia Viñolas emphasized: “The expansion of this chemical plant is not only an industrial milestone, but a testament to the talent, effort, and passion of all the people who believed in it.” Minister Miquel Samper added: “The Government celebrates the inauguration of AGC’s new plant and its commitment to our region. This high-value project in such a crucial sector for the Catalan economy, the chemical-pharmaceutical sector, will contribute to the creation of highly qualified jobs.” A strategic investment in innovation and sustainability The 7,500 m² expansion represents a 30% increase in production capacity and introduces the manufacture of HPAPI (Highly Potent Active Pharmaceutical Ingredients) at OEB5 level, enabling AGC to meet growing demand from clinical development to commercial supply. Designed to handle volumes from grams to tons, the plant covers the entire drug development lifecycle: from initial R&D to commercial manufacturing. Its infrastructure incorporates cutting-edge technologies to safely and efficiently manage OEB5-level HPAPI, including advanced reactors ranging from 1.5 to 7.4 m³ and specific containment areas for HPAPI. The plant’s horizontal layout was conceived to optimize operational control, space utilization, and longterm scalability. It is equipped with systems that meet the highest global standards of safety and quality. Additionally, its modular design allows for seamless integration of future technologies and expansion of its highcontainment capabilities. A comprehensive HPAPI ecosystem Highly Potent Active Pharmaceutical Ingredients (HPAPI) represent the forefront of targeted therapies, enabling treatments capable of combating complex diseases with unprecedented precision. Global demand for HPAPI continues to rise, although their manufacture presents unique challenges, such as containment risks, scalability, and regulatory complexity. AGC Pharma Chemicals has all the facilities ready to scale HPAPI manufacturing: 1. R&D Center 2. Kilo laboratory 3. Quality control laboratories 4. Manufacturing plant With over 20 years of operations without FDA 483 observations and a strong commitment to sustainable innovation, AGC offers comprehensive solutions from discovery to commercialization, setting the industry standard in safety, quality, and flexibility. AGC’s leadership in high-potency manufacturing was recently recognized by the industry with the 2025 CDMO Leadership Awards in the Best Manufacturing Capability category. AGC Pharma Chemicals inaugurates a new advanced manufacturing plant in Malgrat de Mar (Barcelona), with an investment of over 100 million euros
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18 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 NEWS OptymEdge has hired Amy Del Medico as Senior Director, Project Delivery & Transformation, to lead the scale-up and global rollout of ACUVERA — an integrated, AI-powered suite of technology solutions purpose-built for ophthalmology clinical trials. The platform will be soft-launched at next month’s American Academy of Ophthalmology (AAO) event in Orlando. Del Medico brings more than 20 years of clinical trial experience across CROs and biopharma innovators. She spent 17 years at IQVIA, where she served as Director of the Center of Excellence for Ophthalmology, and most recently was Head of Clinical Operations at Vial. Ophthalmology clinical trials are entering a new era of digital transformation, and OptymEdge is leading the industry in the adoption and integration of Visual Function Data Capture Solutions with advanced imaging, AI and analytics. Significantly, ACUVERA will seamlessly connect sites, sponsors, and CROs. By standardizing workflows and enabling real-time access to imaging and clinical data, it ensures more consistent results, allowing faster decision making. “It’s a really exciting time for the business as we lead the digital transformation of ophthalmology clinical trials,” said Del Medico. “My focus will be on driving the global roll-out and adoption of the ACUVERA suite, which includes digital solutions for certification, data capture and ophthalmic image reading. Together, these new tools will enhance data quality and trial efficiency, and my goal is to ensure our delivery team can apply these new technologies and tools while bringing measurable impact to our customers and patients.” ACUVERA has been designed from the ground up as a bespoke solution. Unlike broad eClinical platforms, it combines deep therapeutic expertise with automation, RBQM insights, and endpoint-specific intelligence to deliver best-in-class Visual Function data capture, imaging, and certification. Del Medico added, “By unifying these critical workflows within a single, secure platform, sponsors and CROs can reduce operational complexity, improve endpoint quality, and accelerate study timelines. With many trials now looking to Asia and its large recruitment base, the key challenge is integrating processes across regions - particularly given the diversity of sites and evolving regulatory landscapes. ACUVERA will play a crucial role in harmonizing data, ensuring compliance, and enabling seamless collaboration across regions.” OptymEdge hires Senior Director to drive global roll-out of ACUVERA platform
20 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 NEWS Kindeva, a global CDMO and drug delivery expert, has officially opened its new UK headquarters at Charnwood Campus Science Innovation and Technology Park, Loughborough. The facility represents a significant expansion in Kindeva’s MDI services and will develop and test next-generation propellants (NGP) as the industry prepares to move to more environmentally friendly products. Nestled in the heart of Loughborough’s Technology Park, the 150,000 sq. ft. site offers a range of services across drug development, from early-stage viability, analytical method development, to commercial analysis. Boasting a Chemistry, Manufacturing and Controls (CMC) strategy and regulatory department to guide customers through complex compliance hurdles, the facility will support customers at every stage of the drug development journey. The official opening will be marked with a launch event hosted by the CEO of Kindeva, Milton Boyer and David Northage, Mayor of Charnwood. A ribbon-cutting ceremony will be followed by a site tour, where Kindeva will unveil its investment and recruitment strategy for the future. Commenting on the new site, Milton Boyer said: “The opening of our Loughborough Headquarters marks a significant milestone in Kindeva’s growth strategy as we continue to innovate, scale, and expand our global footprint.” The Loughborough HQ will be responsible for developing and analysing NGPs as the industry faces significant legislation aimed at reducing the environmental impact of the propellants currently used in pressurized metered-dose inhalers (pMDIs). Boyer continued: “Research estimates that inhalers contribute to 0.03% of total global greenhouse gas emissions, and represent 3% of the U.K. National Health Service (NHS) carbon footprint. Investment in our Loughborough site, new technologies and people, will allow Kindeva to become the leading force in the industry for sustainability and assuring supply continuity as the industry transitions to low Global Warming Potential (GWP) propellants.” Kindeva opens new UK HQ and manufacturing site for the development of next-generation propellants
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22 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 NEWS Ncardia, a leader in stem cell– based solutions for drug discovery and safety assessment, today announced the launch of Ncyte® NHP-C vCardiomyocytes, the first commercially available ventricular-like cardiomyocytes derived from induced pluripotent stem cells (iPSCs) of cynomolgus monkeys. New Ncyte® NHP-C vCardiomyocytes provide a scalable, ethical and translational tool for cross-species cardiac studies. The innovation addresses a growing need for physiologically relevant, non-human primate (NHP) in vitro models that reduce reliance on live animals in preclinical research. With the launch of Ncyte® NHP-C vCardiomyocytes, Ncardia empowers the scientific community to conduct crossspecies mechanistic studies, improve predictive modeling of cardiotoxicity and lower risk in drug development — all while advancing more ethical preclinical practices in alignment with the FDA recent animal testing guidance. Ncyte® NHP-C vCardiomyocytes offer a high-purity, functional alternative that closely mimics human cardiac electrophysiology and pharmacology. The cells enable more predictive, scalable and ethical safety screening across species, supporting pharmaceutical and biotech companies in advancing safer therapies. “As the only iPSC-derived NHP ventricular cardiomyocytes on the market, Ncyte® NHP-C vCardiomyocytes set a new standard for translational cardiovascular research,” said Jeroen de Groot, divisional chief executive of Ncardia. “They give researchers the ability to perform direct crossspecies comparisons in vitro, improve cardiotoxicity risk assessment and meet the FDA’s evolving expectations around reducing the use of live nonhuman primates in safety testing.” Ncardia launches first-of-its-Kind iPSC-derived non-human primate cardiomyocytes to advance cardiac safety research At this year’s CPHI Europe in Frankfurt (28–30 October), BENEO will showcase the latest advancements in granulation with its pharmaceutical-grade isomalt excipient: galenIQ™. Visitors are invited to connect with the BENEO team at Stand 8.0L70, where experts will present new data, application samples, and formulation insights for oral dosage forms. As continuous manufacturing becomes increasingly prominent in the pharmaceutical industry, BENEO’s galenIQ™ offers a compelling binder solution. Its unique performance profile includes fast preparation, robust granule formation, excellent flowability, and rapid dissolution – key factors for success in both twin screw and high-shear granulation. Designed to meet the dual requirements of efficient manufacturing and enhanced patient compliance, galenIQ™ combines technical performance with sensory appeal. Thanks to its pleasant, sweet taste and plant-based origin, it supports the development of more palatable and patient-friendly dosage forms. Produced from CPHI 2025: BENEO to present galenIQ™ as the granulation binder of choice
23 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 NEWS beet sugar, BENEO’s filler-binder is non-synthetic and peroxidefree. In addition to aligning with modern consumer needs, it also provides formulators with a stable, consistent, and reliable excipient solution. Proven performance in modern granulation In recent internal trials, galenIQ™ delivered impressive results across key metrics for twin screw granulation (TSG). It showed excellent compactability and produced high-strength tablets (>1.8 MPa) while maintaining rapid disintegration – a desired combination in continuous manufacturing. These attributes make galenIQ™ a particularly strong performer for TSG lines when stability, throughput, and formulation flexibility are essential. “galenIQ™ sets a new benchmark in excipient functionality. Unlike traditional binders, the isomaltbased excipient showed lower sensitivity to concentration levels. Formulators benefit from greater process control and more consistent product quality. This combination of reliability and performance makes galenIQ™ a strong choice for manufacturers seeking both efficiency in production and confidence in regulatory compliance,” says Dr Maj-Britt Cepok, Head of Pharma at BENEO. Discover galenIQ™ at Stand 8.0L70 Meet the BENEO team during the show and discover why galenIQ™ is the granulation binder of choice for modern manufacturing. Experience new data, application samples, and expert insights that show how this excipient performs in granulation processes – all while enhancing patient compliance. Don’t miss the chance to see how galenIQ™ can elevate your formulations and streamline your processes. Hovione, an international integrated pharmaceutical development and manufacturing organization, and Microinnova Engineering, a recognized leader in continuous process intensification, today announced a partnership to advance the development of multipurpose, plug-and-play modular equipment for flow chemistry. The companies will work together to test Microinnova’s modular manufacturing equipment in an industrial setting. The Microinnova equipment is designed to offer greater flexibility, easier scalability, enhanced efficiency and sustainable practices in active ingredient production. Together, the companies are aiming at faster process development, simple transition from lab to large-scale manufacturing, and ultimately decreased time to market for pharmaceutical customers. “This collaboration with Microinnova underscores Hovione’s commitment to innovation in pharmaceutical manufacturing, with flow chemistry playing an important role in our long-term drug substance strategy,” said Dr. Jean-Luc Herbeaux, CEO of Hovione. “This partnership will allow us to shape and validate emerging continuous manufacturing technologies, which can potentially accelerate drug development and production.” Dr. Dirk Kirschneck, Founder and Strategic Director at Microinnova. “This partnership reflects our shared vision to deliver modular manufacturing technologies that support pharmaceutical innovation and manufacturing excellence. We are proud to join forces with Hovione to showcase the capabilities of our next-generation modular equipment in a dynamic CDMO environment, demonstrating its versatility for multipurpose manufacturing.” Hovione and Microinnova partner to advance modular flow chemistry for multi-purpose manufacturing
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