ARx leverages over 60 years of expertise in film and adhesive polymer science to develop transdermal, oral, buccal, and sublingual thin films. These films enhance drug release, absorption, and bioavailability, advance pharmacokinetics, and improve patient safety and experience. A pioneer in novel dosing strategies, ARx partners closely with clients to push the boundaries of drug delivery, offering end-to-end solutions from feasibility through FDA-registered manufacturing. With demonstrated success in commercializing branded and generic drug products and by setting higher standards for quality, safety, and efficacy, ARx continues to expand therapeutic potential and redefine what’s possible in modern medicine.
Ardena
Ardena is as a fully integrated Contract Development and Manufacturing Organization (CDMO), with a core focus on bringing molecules to the clinics. Our comprehensive suite of services caters to every stage of pharmaceutical development, ensuring a smooth progression from initial idea to clinical application. From small-molecule API projects, to drug product development, navigating phase-appropriate processes under cGMP conditions, and facilitating clinical packaging and logistics. Furthermore, as experts in nanomedicine development, we offer scalable formulation, process, and analytical development, alongside GMP manufacturing, ensuring our partners meet their clinical schedules effectively. Ardena is also recognized for its expertise in bioanalysis solutions that cater to diverse drug products and biomarkers, spanning small molecules to proteins, including antibodies, ADCs, oligonucleotides, and vaccines. As your trusted CDMO partner connect with our team at the California Pavilion and let us assist you on your journey towards clinical success. | Ardena is a specialist CDMO and bioanalytical CRO advancing precision medicines and other complex therapies from early development through to commercial supply. The company supports biotech and pharmaceutical partners in translating challenging molecules into scalable, robust therapies. Its strength lies in combining complex drug product development and GMP manufacturing, bioanalytical services, and specialized expertise in nanomedicine and conjugates within one integrated framework. This approach reduces complexity, shortens timelines, and supports efficient progression across development stages. Ardena focuses on modalities that demand advanced formulation and analytical precision, including nanoparticles, conjugates, and other complex drug products. In nanomedicine, the company supports lipid-based, polymer-based, and metal-based systems, optimizing formulation, scalability, and manufacturability. Drug product capabilities span formulation development, process scale-up, and GMP manufacturing for clinical and commercial supply. Enabling technologies such as spray drying and hot melt extrusion address solubility, stability, and bioavailability challenges, alongside expertise in highly potent and complex dosage forms. Ardena also supports the development of conjugates, including antibody-drug conjugates (ADCs) and other novel conjugates (XDCs). These programs require tight integration of chemistry, formulation, and analytics, combined with containment and GMP expertise to ensure consistency from early development through to commercial manufacturing. Bioanalytical services are a central pillar, delivering pharmacokinetic, biomarker, and immunogenicity analysis to support clinical development and regulatory submissions. Ardena operates established bioanalytical laboratories in Europe and has expanded into the United States with a new lab in Somerset. Ardena’s international network spans Europe and the US, enabling regional flexibility and continuity from development to commercialization. The Somerset site plays a key role, offering GMP drug product manufacturing for clinical and commercial supply, alongside integrated bioanalytical capabilities. As an FDA-approved facility, it provides a strong foundation for programs targeting the US market, with clear advantages in supply chain efficiency and market access. What differentiates Ardena is the integration of its expertise. Multidisciplinary teams align development, manufacturing, and analysis from the outset, reducing rework and supporting consistent execution. Supporting capabilities in solid-state research and CMC development further strengthen programs and de-risk critical decisions. At this event, Ardena brings practical insight across the full development lifecycle, supporting focused discussions on how to advance complex therapies with speed, control, and confidence. Visit Ardena at booth 3253. Ardena enables progress where complexity defines the challenge.
ARCALIS
ARCALIS leads the world as the most advanced CDMO for mRNA vaccines and therapeutics. ARCALIS is a contract development and manufacturing organization (“CDMO”) for messenger RNA (mRNA) vaccines and therapeutics. The company was jointly established by Axcelead, Inc., the first drug discovery platform company in Japan, and Arcturus Therapeutics, a US-based, global, late-stage clinical mRNA medicines company. mRNA is a new therapeutic and vaccine modality that was only recently commercialized in the wake of the Coronavirus infection, but the challenge toward practical application has been ongoing since the 1990s. Research and development of mRNA have begun targeting not only infectious diseases, but also therapeutics and vaccines for various applications, such as rare diseases, cancer, regenerative medicine, and genome editing.The company provides drug discovery support, CMC development, and manufacturing support services for mRNA therapeutics and vaccines to pharmaceutical and biotech companies. These services are backed by expertise accumulated in Arcturus in the fields of manufacturing technologies.
Andelyn Biosciences
Our Vision: Pioneering Solutions that turn Hope into Reality Our Mission: Accelerating the development and manufacturing of innovative therapies to bring more treatments to more patients Andelyn Biosciences (https://www.andelynbio.com/) is pioneering solutions that turn hope into reality as a cell and gene therapy CDMO. Capabilities span viral vector process and analytical development, small to large scale adherent and suspension based GMP manufacturing up to 2000L. Having 20+ years of experience with viral vector manufacturing, Andelyn offers access to globally recognized thought leaders with troubleshooting/characterization expertise and GMP material produced for 75+ worldwide clinical trials. In addition to producing 400+ cGMP clinical batches, Andelyn provides research and tox grade plasmids with an additional offering of GMP plasmid manufacturing, full quality system/regulatory support and supply chain vertical integration. Its state-of-the-art 185,000 sq ft commercial manufacturing facility will expand capacity across 8+ production suites for customization of new programs and tech transferred programs, offering clinical through commercial-scale capabilities that will help accelerate innovative therapies to bring more treatments to more patients. Gene and cell therapy, AAV viral vector manufacturing, Plasmid Manufacturing, Lentiviral vector Manufacturing, Commercial Manufacturing, CDMO, analytical method development, GMP, fill finish, QC/QA release testing, Process Characterization, Regulatory Affairs, Licensing Andelyn Biosciences is a pioneering cell and gene therapy organization born out of Nationwide Children’s Hospital, where the first FDA-approved systemic gene therapy was discovered. See all our Press Releases at: https://www.andelynbio.com/media-center | Andelyn Biosciences (https://www.andelynbio.com/) is pioneering solutions for Turning Hope into Reality (TM) as a gene therapy CDMO. Capabilities span viral vector process and analytical development, small to large scale adherent and suspension based GMP manufacturing up to 2000L. With 20+ years of experience in viral vector manufacturing, Andelyn offers access to globally recognized thought leaders with troubleshooting and characterization expertise and GMP material produced for 75+ worldwide clinical trials. In addition to producing 450+ cGMP sublots, Andelyn provides research, tox, and GMP grade plasmids Andelyn also has full quality and regulatory support and supply chain vertical integration. Its state-of-the-art 185,000 sq ft commercial manufacturing facility offers capacity across 16 production suites for customization of new programs as well as tech transfer programs, offering clinical through commercial-scale capabilities that will help accelerate innovative therapies to bring more treatments to more patients. Andelyn Biosciences is a pioneering gene therapy CDMO born out of Nationwide Children’s Hospital, where the first FDA-approved systemic gene therapy was discovered. | Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on the development, characterization and production of viral vectors for gene therapy. With more than 20 years of experience, Andelyn’s deep scientific expertise has resulted in the production of cGMP material for more than 450 clinical batches and 75 global clinical trials. Operating out of its development and manufacturing facilities in Columbus, Ohio, Andelyn supports its clients in developing cell and gene therapies from concept through plasmid engineering and manufacturing, process and analytical development, and cGMP clinical and commercial manufacturing. Andelyn can accelerate programs and deliver high quality products by developing and manufacturing processes on its configurable, data-driven AAV CuratorTM Platform, or tech transferring in an established client program. Capabilities include cGMP manufacturing for suspension processes up to a 2,000-liter and adherent processes. A rigorous quality system, regulatory support, and supply chain vertical integration further support clients in bringing their critical therapies to market. For more information, visit andelynbio.com. For Andelyn media inquiries, please contact: media@andelynbiosciences.com
Almac Group
Almac Diagnostic Services We are a precision medicine company specialising in biomarker driven clinical trials. Our global CLIA and CAP accredited laboratories cover UK, Europe, USA and APAC regions. Our cores services: * Multi-Omic Services: We offer a range of genomic & proteomic platform and chemistry options, alongside expert data sciences support & a specialty central lab service. * Clinical Biomarker & CDx Development: Custom Clinical Biomarker & CDx development, validation & delivery service from our CLIA & CAP accredited laboratories in USA, Europe and APAC. * Clinical Testing: Global clinical trial testing service from our clinical laboratories, including a menu of platforms & assays and an integrated specimen collection & logistics service. Find Out More www.almacgroup.com/diagnostics | The Almac Group is an established contract development and manufacturing organization providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Operating from state-of-the-art facilities in the US, Europe, and the UK, Almac Pharma Services is a FDA, HPRA, and MHRA approved CDMO partnering with global pharmaceutical and biotechnology industries. We have over 50 years’ experience in providing a comprehensive range of tailored solutions. Almac possesses a wealth of technical expertise to support the delivery of your complex projects. Our scientists can develop your clinical candidate into an optimum formulation, and solid manufacture oral dose products for all stages of clinical trials. Almac’s integrated pharmaceutical development solutions are tailored to meet your needs. We specialise in the manufacture & primary packaging of solid, oral dosage forms (Tablets, Capsules and Powders). As well as customised secondary packaging for all drug products including ultra-low temperature drug products. Almac works in close partnership with our clients offering unique solutions designed to support the efficient and successful development, and commercialisation of new treatment options. | Operating from state-of-the-art facilities in the US, Europe, and the UK, Almac Pharma Services is a FDA, HPRA, and MHRA approved CDMO partnering with global pharmaceutical and biotechnology industries. We have over 50 years’ experience in providing a comprehensive range of tailored solutions. Providing end-to-end integrated solutions to bring your drug product from development through to commercialisation from a single source. We work with clients to provide pharmaceutical development, manufacturing, product launch, and packaging solutions to fit their unique needs. Our team of experts can support the development of fit-for-purpose formulation for First-in-Human trials, to developing a more robust formulations scaling up for late phase trials, and ultimately commercialisation. Supporting key development and manufacture areas such as paediatrics, potent and highly potent products. We provide primary and secondary packaging for all drug products including ultra-low temperature drug products and specialised kit assembly. Almac was one of the 1st EU CDMOs to support gene therapy product launches, and currently supports 25% of EU approved/pre-registration Gene Therapy solutions. We provide end-to-end management of drug product supply, including distribution, packaging design, and support initial and ongoing global product launch. We provide unique, tailormade solutions designed to support the efficient and successful development, and commercialisation of new treatment options. Partnering with our clients to provide flexible, stable, ongoing supply to meet their product pipeline needs. | The Almac Group is a global leader in providing a range of expert services and support across the drug development lifecycle. A privately owned organisation, under the McClay Foundation, Almac has grown organically over the past five decades, now employing over 7,500 highly skilled individuals across 18 locations in Europe, the US and Asia. Almac Group is comprised of 5 Business Units: • Almac Diagnostic Services • Almac Sciences • Almac Pharma Services • Almac Clinical Services • Almac Clinical Technologies Each Business Unit offers specialist and dedicated solutions at each phase of the product lifecycle providing the ability to select single or multiple, integrated solutions to meet your unique needs. Our unique combination of inspirational people, exceptional innovation and outstanding quality, enables us to provide tailored solutions for your specific requirements – either on a single, standalone project or on a long-term basis as your strategic partner. About Almac Pharma Services: With over 55 years’ experience, Almac Pharma Services is an established, reliable and world leading outsourcing partner to the global pharmaceutical and biotechnology industry. Employing over 1,800 highly skilled individuals across 4 locations in Europe and the US, we provide a range of tailored, quality-led and timely solutions from early and late phase pharmaceutical development, clinical and commercial drug product manufacture, product launch through to commercial packaging and global distribution. Currently supporting client portfolios across more than 70 countries, our fully integrated, end-to-end solutions are tailored to meet the needs of your unique products, and, ultimately, your patients. Pharmaceutical Development Solutions: Spanning both early and late phase development, our teams of expert scientists possess a wealth of experience in developing clinical candidates into optimal formulations and manufacturing high-quality oral dose products for all phases of clinical trials. Operating both non-GMP and GMP facilities we have complementary equipment trains and integrated technical teams to facilitate technology transfer providing a seamless transition between formulation and process development, and clinical trial material manufacturing. Through a range of flexible and fully tailored unit operations including blending, roller compaction, high shear granulation, encapsulation (including Xcelodose) micro encapsulation and fluid bed processing, we offer the following oral dose formulations with batch sizes ranging from grams to tons: • API / powder in hard gelatin capsules or bottles, including micro-dosing • Formulated blends in hard gelatin capsules or bottles • Tablets (coated) • Mini-tablets • Granules • Beads/pellets • Non-sterile liquid in capsules or bottles • Immediate and modified release • Fixed dose combination products • Potent and highly potent products (OEL as low as 0.05 ug/m3/8 hours) • Specialist paediatric drug development expertise Analytical Solutions: We employ over 700 highly skilled analysts working in state-of-the-art, fully certified GMP laboratories across Europe and the US with significant experience in the analysis of both small and large molecules. We support drug substance (API) and drug product (finished product) analytics across all phases of clinical development through to commercial release. We offer a range of tailored services including: • Method development • Method validation • Method transfer • Stability programmes • Release analysis: all lifecycle stages • Spectroscopy services • Investigational analysis • Reference standard management • Microbiological testing • Physical sciences • Bio-pharmaceutical testing • Analytical support for clinical trial supplies Commercial Manufacture Solutions: Scaling up from our oral dose development assets and expertise through registration and launch into commercial supply, or transferring existing commercial products, we support your commercial manufacturing needs with flexibility and expertise. With blend sizes from 10kgs up to 2.5 tons, our range of state-of-the-art processing equipment is designed to enable scalability to the batch size requirements of your product for a range of presentations including: • Tablets • Mini-tablets • Capsules • Powders • Granules • Beads/pellets • Non-sterile liquids • Potent and highly potent products (OEL as low as 0.05 ug/m3/8 hours) • Specialist paediatric drug manufacturing expertise Commercial Packaging Solutions: Our high and low throughput operations provide the flexibility and efficiency necessary to meet your ongoing and fluctuating demand. Our commercial facilities in Europe and the US, combined with our local expertise offers flexible, quality-led commercial pharmaceutical packaging solutions tailored to meet your specific needs. Our range of primary packaging solutions include: • Tablets • Mini-tablets • Capsules • Powders • Granules • Non-sterile liquid • Our secondary packaging, labelling and assembly capabilities include: • Bottles Vials / ampoules • Pre-filled syringes • Wallets / blister cards • Auto-injectors • Cartons • Sachets • Stick packs • Offline blister printing Innovative, specialist packaging solutions including: • Specialist paediatric drug packaging expertise • Expert cell and gene therapy (ATMP) Ultra Low Temperature (ULT) solutions (-20° to -80°) • Complex medical kit assembly solutions via our unique, custom built semi-automated packaging technology Support Solutions: We provide a wide range of tailored support and consultancy services to help guide you through every aspect of your unique development and commercialisation journey. Find out more – www.almacgroup.com
Agilent Advanced Therapeutics, fka BIOVECTRA
Agilent Advanced Therapeutics is Agilent’s contract development and manufacturing organization (CDMO), bringing together BIOVECTRA’s proven expertise in biologics fermentation, complex chemistry, highly potent APIs, and bioreagents, with Agilent’s Nucleic Acid Solutions Division capabilities in oligonucleotides and advanced nucleic acid manufacturing. Together, these complementary strengths create a unified CDMO partner supporting advanced therapeutics from development through commercial supply. Combining white-glove service, deep scientific expertise, and long-term investment, Agilent Advanced Therapeutics delivers customized end-to-end solutions designed around each client’s needs. Backed by rigorous, data-driven processes and Agilent’s global quality systems, our scientists work alongside yours to help move programs forward with confidence. Invested in science, invested in your success.
Afton Scientific
Afton Scientific is a highly-experienced cGMP CMO specializing in sterile injectables. We can Formulate, Aseptically Fill, Label, and Package your small-batch parenterals. Our customers include major global pharmaceutical companies and emerging biotechs. Sterile manufacturing services offered Clinical Trial and Commercial Drug Products Both Small and Large Molecule Inspected by Both CDER and CBER International Standards – FDA, PMDA, MHRA, and EMA Terminal Sterilization Engineering and Formulation Scale-Up Commercial Batch Record Development Technology Transfer Analytical Support Regulatory Filing Assistance Label/Pack/Serialization Our flexibility allows us to get client projects on the schedule as quickly as possible and maintain robust regulatory compliance. Quality assurance and in-house analytical services allow us control over product release timelines to ensure that products hit the market or clinic on time. Our facilities can handle vial sizes from 2mL – 100mL and batch sizes from thousands to tens of thousands making us an ideal fit for small-run commercial drugs and clinical trial materials. | Afton Scientific is a U.S.-based CDMO specializing in aseptic fill-finish for biologics and small molecule products, with more than 20 years of manufacturing excellence. We are early technology adopters, and our newest capability reflects that commitment: a state-of-the-art, Annex 1–compliant isolator-based filling line supporting vials, syringes, and cartridges, purpose-built to meet the highest standards in sterile manufacturing and position our partners for global market access. What sets Afton apart is how we work. Our clients have direct access to experienced leadership and technical teams from day one. We embed ourselves in your program, bring deep technical expertise, and stay close through every stage of development and manufacturing. With available capacity today, a growing facility footprint, and a culture built around solving hard problems, Afton is ready to support your program now and as it scales.
Aenova
The Aenova Group is a leading global contract manufacturer and development services provider for the pharmaceutical and healthcare industry. Our services include end-to-end manufacturing and development of all dosage forms and potency levels (ranging from nutraceuticals to high-potents) out of 15 sites in Europe and the US. Aenova can offer sterile compounding and filling of liquids in Pre-Filled Syringes, either aseptically filled or terminally sterilized, on filling lines equipped with barrier technology (RABS or Isolators). Aenova is the ideal partner for development and production of virtually all types of solid dosage forms and APIs up to OEB 5. Aenova has more than 35 years of experience in the formulation and analytical development and production of soft gelatin capsules. Our production facilities are equipped with state-of-the-art equipment to process any formulation and any capsule design, color and size. With development and manufacturing capacities including high potent active pharmaceutical drugs at our Center of Excellence in Kirchberg/Switzerland also with the ability to manufacture with high potent active pharmaceutical ingredients which can be handled within adequate equipment like gloveboxes for OEB 5 level and closed process tank systems. With our comprehensive know-how, many years of experience, well-trained staff of 4,200 employess, innovative technologies and highest quality standards we are a reliable, long-term partner to pharmaceutical and consumer health care customers around the world, both in the human and veterinary healthcare market. | Aenova is one of the leading contract development and manufacturing organizations (CDMOs) in the global pharmaceutical supply chain. They provide services covering the entire value chain from development to commercialization for all common product groups and dosage forms (solid, semisolid, sterile, and nonsterile liquid). The company supplies drugs up to OEB 5 and food supplements for both human and veterinary use. They are also able to handle differentiated technologies such as HPAPI containment, low-dose, modified release formulations, organic granulation, particulate systems, lipid-based formulas, HME or spray drying for poorly soluble compounds. Aenova offers customers a wide-ranging service portfolio and challenges itself to expedite time to market and facilitate the drug development journey. The one-stop-shop experience stretches from early phase formulation and product development to the purchase of raw materials, analytics, regulatory support, small and full-scale production, market release through to packaging and logistics. Aenova develops, produces and packages across a network of 14 sites in the US, Germany, Switzerland, Italy, Ireland, and Romania, with headquarters near Munich, Germany. The manufacturing sites are complemented by seven specialized Development Competence Centers for various technologies and dosage forms that support clients with tailormade solutions. A highly motivated international team of nearly 4,000 employees from over 50 nations contributes to the group’s strong, long-lasting customer partnerships and continuous development. Excellence & Reliability are anchored in the company culture as core values, benefiting customers in the shape of ample capacities, back-up sourcing within the group, and continued capital investment in capacities and capabilities. In line with a “Customers & Patients first” mentality, a dedicated Business Management team is in place to provide personalized customer service, address needs and solve potential issues efficiently. Aenova’s client base consists of most of the leading global players in pharmaceuticals, consumer healthcare, veterinary health and dietary supplements, as well as many small and mid-size pharma and biotech companies. Surveys show that the majority of the group’s clients consider Aenova their preferred supplier and report a strong overall satisfaction in working with the group. | Aenova Group – CDMO Value Creation Across the Entire Product Lifecycle Aenova is one of the leading contract development and manufacturing organizations (CDMOs) in the global pharmaceutical supply chain. They provide services covering the entire value chain from development to commercialization for all common product groups and dosage forms (solid, semisolid, sterile, and nonsterile liquid). The company supplies drugs up to OEB 5 and food supplements for both human and veterinary use. They are also able to handle differentiated technologies such as HPAPI containment, low-dose, modified release formulations, organic granulation, particulate systems, lipid-based formulas, HME or spray drying for poorly soluble compounds. Aenova offers customers a wide-ranging service portfolio and challenges itself to expedite time to market and facilitate the drug development journey. The one-stop-shop experience stretches from early phase formulation and product development to the purchase of raw materials, analytics, regulatory support, small and full-scale production, market release through to packaging and logistics. Aenova develops, produces and packages across a network of 14 sites in the US, Germany, Switzerland, Italy, Ireland, and Romania, with headquarters near Munich, Germany. The manufacturing sites are complemented by seven specialized Development Competence Centers for various technologies and dosage forms that support clients with tailormade solutions.
3PBIOVIAN
3PBIOVIAN is a globally operating Contract Development and Manufacturing Organization (CDMO), delivering end-to-end services for biotech and pharma companies. Our service offering includes microbial and mammalian protein expression platforms, viral vector production for adenoviruses and adeno-associated viruses, cell therapy, and plasmid DNA production. Additionally, we provide fill and finish services for recombinant proteins and viral vectors. With a combined track record of 40 years in process development and analytical methods development, complemented by our experience in process scale-up, GMP manufacturing, and commercial supply, we are equipped to offer comprehensive manufacturing services at all stages, encompassing Drug Substance and Drug Product. Our manufacturing sites in Pamplona-Noáin, Spain, and Turku, Finland seamlessly support the diverse needs of our clients, covering pre-clinical and clinical supply to full-scale commercial manufacturing. | 3PBIOVIAN is a globally operating Contract Development and Manufacturing Organisation (CDMO), providing unparalleled end-to-end development and manufacturing services for biologics and advanced therapies. Collaboration is at the core of how we work. We partner closely with our clients, adapting to their unique needs and guiding them through every stage: from clinical development and trials to commercial production. Our client-oriented approach ensures seamless project execution and efficient progression. Our service offering spans multiple platforms, including microbial and mammalian expression systems, adenoviruses, adeno-associated viruses (AAV), cell therapy, and plasmids. With a diverse range of bioreactor sizes, we offer flexible production scaling to meet the needs of biopharmaceutical companies worldwide. Leveraging decades of expertise and extensive capabilities, we position ourselves as a leading pan-European independent biologics CDMO, dedicated to advancing therapies that address patients’ unmet clinical needs, making advanced biologics and tomorrow’s life transforming therapies. GMP certified 3PBIOVIAN offers GMP manufacturing services for microbial and mammalian protein expression platforms, viral vector production for adenoviruses and AAVs, cell therapy, and plasmid DNA production. Summary of services › Plasmid DNA production › Cell line development › GMP cell banking and Virus Seed Stock production › Process development and optimisation › Technology transfer › Analytical methods development, qualification, and validation › Scale-up and cGMP manufacturing › Formulation development › Fill and Finish › Quality Assurance (QA) and Quality Control (QC) › Drug Substance (DS) & Drug Product (DP) release GMP manufacturing capacities › Mammalian, single use bioreactors: 50L, 200L, 400L, 2000L › Microbial, stainless-steel bioreactors: 10L, 100L, 200L, 500L, 1000L › Viral Vector manufacturing: • Adherent: Up to 500 m2 • Suspension: 10L, 25L, 50L, 200L › Plasmid DNA, stainless steel bioreactors: 25L, 40L, 200L