BiBo Biopharma Engineering Co. LTD. (BiBo Pharma) is a Contract Development and Manufacturing Organization (CDMO) focus on biologics. We are one of the few organizations in the world with comprehensive experience of construction and operation experience of large-scale biologics production lines, and committed to setting up new CDMO industry standards with our world-leading PanFlex® -Engineering capacity and integrated management system. We offer full-spectrum and one-stop-shop services from R&D to commercial production for multi-platforms, including microbial fermentation, mammalian cell culture, and gene therapy. BiBo’s 30,000L large-scale manufacturing capability, which is the first in China and the 2nd in the world, can provide our client with state-of-the-art service for commercial production. | BiBo Pharma is a full spectrum CDMO covering the entire CMC lifecycle of biologics. BIB has multiple technology platforms, including microbial fermentation, mammalian cell culture, ADC & GMP facility engineering service. Empowered by PanFlex®-Engineering, our specialist team innovated the world’s first and largest 50,000L and 30,000 L stainless steel ultra-large bioreactor for mammalian cell culture production, and 50,000L and 30,000L high cooling capacity fermenters enabling ultra-high-cell-density fermentation. We have bioreactors and fermenters ranging from 50L to 50,000L and can provide high quality, on time drug supply for GLP tox studies through clinical trials and commercial supply. BiBo’s core team members come from world-leading companies in the US, Europe, and China. We have accomplished over 100 biologics projects, including over 30 in clinical and commercial stages. Our CMC service package includes cell line and strain development, process development, analytical development, formulation development, toxicological and GMP production of drug substance and drug product, process characterization, and large-scale production. We are the world leader in the fourth wave of biomanufacturing. Not only have we established the world’s first and largest 50,000L ultra-large mammalian production line, but it has also achieved a 100% success rate on all scale-up projects by applying our innovative “success on the first time” system.
August Bioservices
August Bioservices is a Contract Development and Manufacturing Organization (CDMO) headquartered in Nashville, Tennessee. August Bio offers a full range of pharmaceutical contract development and manufacturing services to pharmaceutical and biotech clients. We focus on sterile injectables, highly-complex formulations, poorly soluble & highly viscous compounds, Uncommon container sizes & fill volumes and offer aseptic and non-aseptic terminally sterilized filling of vials, syringes and flexible IV bags.
Asymchem
Founded in 1999, Asymchem is a global integrated Contract Development and Manufacturing Organization (CDMO) providing drug R&D and manufacturing for leading pharmaceutical and biotech companies. Our mission is to drive smarter, greener and more cost-effective manufacturing to support clinical research and commercialization. Asymchem currently operates eight manufacturing facilities offering solutions ranging from early clinical stage to commercial stage, including R&D, cGMP production of advanced intermediates, APIs, formulations and clinical research services. Our scientists excel in the creation and manufacture of enzymes for use in bio-catalysis, the development of practical continuous flow technologies for commercialization, and innovative research and process development from preclinical research to commercialization for both non-GMP or GMP products. Our work has frequently won us “most valuable partner” and “strategic partner” recognition from major pharma and leading biotech companies. For more information, please visit www.asymchem.com. | Asymchem is a leading global CDMO known for its integrated offerings throughout the entire drug development lifecycle. From early-stage research to commercialization, we provide a tailored suite of services that cater to the specific needs of each project. We are committed to embracing cutting-edge technologies that not only enhance efficiency and safety but also prioritize sustainability in the development and manufacturing process. This translates to smarter, greener, and more cost-effective solutions for our clients, ultimately speeding up the delivery of life-saving medications to patients. | Asymchem (Stock Code: 002821.SZ/6821.HK), a global CDMO leader, has provided one-stop pharmaceutical solutions for over 25 years. With a strong foundation in small molecule services, it has advanced capabilities in TIDES, biologics, drug products, clinical research, synthetic biology, and technology transfer. Supported by over 9,000 professionals—45% in R&D—and facilities in China, the U.S., the U.K., and beyond, Asymchem adheres to top-tier cGMP and EHS standards. Trusted by global pharma and biotech leaders, Asymchem delivers high-quality, cost-effective services, reducing time-to-market for therapies and providing client-centric solutions to meet the diverse needs of global drug development.
Ascendia Pharmaceutical Solutions
Ascendia Pharmaceutical Solutions specializes in complex formulation development and manufacturing of pharmaceutical and biologic products using a suite of novel formulation technologies. We provide formulation, analytical, and manufacturing services to pharmaceutical companies, working collaboratively to provide innovative solutions to challenging drug delivery problems and to create advanced medicines. CREATING FORMULATIONS FOR CHALLENGING MOLECULES Ascendia’s expertise involves finding the most effective method of drug delivery for poorly soluble and/or bioavailable molecules. Our comprehensive range of capabilities enables clients to optimize their drug product formulation prior to initiating expensive clinical development. Ascendia provides practical, customized formulation solutions that enable rapid advancement of compounds from discovery to clinical testing. We create trial formulations suitable for PK and tox studies using our nano-emulsion, amorphous solid dispersion, controlled release, LNP and other nanoparticle engineering approaches. We conduct preformulation testing, formulation approach comparisons, dosage form design, and formulation optimization. By working with Ascendia, our clients can quickly determine the feasibility of multiple technical approaches in parallel, thus improving the probability of formulation success and reducing the time required to make critical early-stage formulation decisions. cGMP MANUFACTURING Following formulation selection and optimization, Ascendia can quickly transition a development program to cGMP manufacturing of first-in-man clinical materials. With both aseptic and non-aseptic manufacturing suites in its New Jersey (USA) facility, the company can handle various dosage forms, including those for oral, topical or parenteral administration. Ascendia offers its manufacturing services to third parties that need a CDMO partner for their formulations advancing from preclinical to clinical stages of development. LIFE-CYCLE MANAGEMENT AND 505(b)(2) PRODUCT DEVELOPMENT Ascendia is dedicated to the solubility, bioavailability and stability enhancement of difficult-to-formulate compounds. Our proprietary product development programs focus on creating novel specialty pharmaceutical products that are improved versions of existing medicines. We develop oral, topical and injectable products for clients via the 505(b)(2) NDA pathway, as well providing formulation development and manufacturing for complex generic (ANDA) products.
ARx
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.
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
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.