Vision. Expertise. Success. AbbVie Contract Manufacturing partners with companies across the globe to develop, scale and manufacture pharmaceutical products and bring them successfully to market.
Drawing on more than four decades of success as the manufacturing division of AbbVie, we have the depth of experience and the technical knowledge to navigate issues and deliver the innovative solutions customers need. We are much more than a CMO – we are your partner for success.
With foresight, scientific expertise, and passion we anticipate the technical and compliance challenges along the entire pharmaceutical development journey through to commercialization. We see the complete picture to deliver our customer's vision.
With full access to global state-of the-art facilities and world-class talent, our customers have come to depend on our service and quality to deliver real-world results.
Visit abbviecontractmfg.com for more information.
Aprecia is the biopharmaceutical leader in advanced additive manufacturing technologies. As a specialty CDMO,we help you overcome formulation challenges. Through novel oral dosage forms, we are reimagining medicine so patients and caregivers can live their best lives.
We are Ardena, a reputable contract partner delivering drug development, manufacturing, logistics and (bio)analytical services to pharmaceutical customers globally. In parallel, we work with you to compile your regulatory dossier and to fast track your product towards compliance. Every day, we guide companies through the hurdles and challenges of drug development. Our integrated service offering helps to streamline the drug's progress to clinic and beyond. Ardena is your one source contractor for the chemical and pharmaceutical development of your valued compounds. In parallel, we provide you with full product analytical and bioanalytical support during development. Our dossier-centric approach makes a difference. We work with you to compile your regulatory dossier in parallel with drug development, saving you time, identifying hurdles and fast-tracking your product to compliance. We are experts in writing and formatting supporting CMC documentation.
Asahi Kasei is a highly diversified Japanese supplier of high-performance materials for various industries, including automotive, energy, electronics, housing and health care. In the fields of pharma- and nutraceuticals, we offer functional excipients. For many decades Asahi Kasei stands for quality, reliability and performance and is dedicated to “Creating for Tomorrow”.
Our key product is Ceolus, functional grades of microcrystalline cellulose (MCC) with outstanding compactability and flowability due to a special particle structure. This allows for avoiding typical formulation challenges like tablet mass segregation, capping, slow/fast disintegration, low tablet hardness or the changing of the API structure. Celphere, Asahi Kasei’s MCC spherical cores allow the combination of incompatible APIs in one tablet, achieve different release profiles and improve the acceptability of products. Special grades of our pregelatinized starch PC-10 can be applied for the protection of moisture sensitive APIs in the formulation.
Our functional excipients prove to be solutions to our customer’s daily challenges.
Founded in 2007, AustinPx is a fee-for-service CDMO offering preclinical through Phase II formulation and process development and GMP manufacturing of oral dosage forms. We specialize in bioavailability enhancement, speed to clinic and market development strategies, and dose form development.
The name AustinPx represents where we come from and what we do. Px stands for Pharmaceutics. To our core, we are a pharmaceutics company. Our approach is data-driven and agnostic which means our formulation strategy for each drug is based on the unique physiochemistry of that compound. And for poorly soluble compounds, we have one of the most powerful tools available in KinetiSol®, a truly next generation technology for rendering active pharmaceutical ingredients amorphous.
KinetiSol™ TechnologyThe KinetiSol Technology generates amorphous solid dispersions (ASD), dramatically improving the bioavailability of poorly soluble drugs. KinetiSol is a fusion-based, solvent-free process that utilizes frictional and shear energies- in a fraction of the time of other ASD technologies. With its significantly smaller ecological footprint, broader formulation design space, faster processing times and wider applications to challenging molecules, KinetiSol is the next generation amorphous dispersion technology.
Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products, including Amgen’s Kyprolis®, Baxter International’s Nexterone®, Spectrum’s EVOMELA® and Melinta Therapeutics’ Baxdela™. There are many Captisol-enabled products currently in various stages of development.
Catalent specialises in comprehensive development, analytical and bioavailability enhancement from candidate selection to fully integrated solutions, to help get customers’ drugs to clinic faster. Using a rigorous, data-driven scientific approach, API-sparing techniques and advanced formulation technologies within a global network, Catalent helps solve complex challenges to accelerate drug development.
Celanese offers the VitalDose® Drug Delivery Platform, providing long-acting controlled release of small molecules, biologics, and nucleotides through implant and insert dosage forms. Work together with Celanese experts in our state-of-the-art feasibility lab for customized materials and service solutions tailored to your application—helping you establish proof of concept.
We are equipped to create functional API-loaded prototypes, characterize and measure in vitro drug release, and provide technical transfer support to our customers and their partners. Backed by years of experience working with global regulatory bodies, we provide customers with relevant certifications and documentation needed throughout various stages of their drug development and approval process.
With decades of experience in medical and pharmaceutical applications, our customers trust us to provide unrivaled service, world-class expertise, and quality that improve product development, enhance manufacturability, and elevate patient experiences.
Learn more about our solutions and capabilities at healthcare.celanese.com.
Corealis Pharma offers complete formulation development and clinical supply manufacture of pharmaceutical oral solid dosage forms for US, European and Canadian submissions. Each project is different and Corealis experts select the most suitable formulation and manufacturing process train for each drug substance as per its intended application. They have in-house access to well-equipped, state of the art R&D and GMP compliant operations such as API characterization, spray drying, hot melt extrusion, solid dispersion, high shear granulation, fluid-bed granulation/ drying/ coating, roller compaction, melt granulation, extrusion/spheronization, pan coating, tableting, encapsulation, packaging, patient kits preparation, warehousing, distribution and analytical services. This means that when Corealis professionals commit to a delivery date and budget, they have all the tools and resources needed to stand by their commitments and the ability to adjust quickly to any changes that may occur in the execution of a project.
Croda Pharma is a leading partner for the development of excipients and the supply of high purity materials for pharmaceutical formulations. The company is focused on empowering biologics drug delivery, through its adjuvant systems, small molecule, protein, and nucleic acid delivery platforms. With a wide range of solutions for both human and animal health markets, the pharmaceutical portfolio is unsurpassed in its excellence. Croda Pharma’s products, along with its in-house formulation and regulatory expertise, allows the company to meet its customers’ most demanding formulation needs. The company is committed to enabling the next generation of drug delivery systems.
Crystal Pharmatech, Inc. is a global technology-driven CRO and CDMO with three R&D centers located in Suzhou (China), New Jersey (USA), and Toronto (Canada). We are distinguished by our comprehensive suite of services from API solid-state research, crystallization, preformulation to formulation development and GMP manufacturing. Our scientific leadership team, averaging 15 years of experience, has successfully delivered over 100 early-phase projects and commercialized 19 products for global pharmaceutical companies. With our distinctive expertise, we partner with clients to design and develop the most appropriate crystal form and formulation for further development. We have served more than 1,000 clients and assisting in the development of over 2,000 new chemical entities.Crystal Bio, our new Business Unit, offers comprehensive biologics analytical services, including CMC-related analyses of structures, purity, degradation studies, and bioactivity correlation with MS identity.
digiM is a technology leader providing CRO services in microstructure analysis and in silico modeling for the development of drug products. Combining advanced microscopic analysis with computational physics, digiM's platform provides a full spectrum understanding of drug product properties and performance. digiM works closely with developers to navigate program challenges and institutionalize knowledge libraries. In addition to services, digiM provides I2S, a cloud-based image analytics and data management platform.
Since 1880, Gattefossé has developed and manufactured high-quality lipid excipients for human and animal health. Our oral excipients offer solubility/bioavailability enhancement, sustained release, lubrication, and taste-masking. We also provide solubilizers, penetration enhancers, emulsifiers, and viscosity enhancers for improved topical formulations, as well as suppository and pessary bases. All Gattefossé products are backed by comprehensive safety, quality, and regulatory documentation to support your formulation and manufacturing needs. To accelerate development, our team of highly trained experts offers hands-on support through four Technical Centers of Excellence located in France, China, India, and the United States.
Gerresheimer is the global partner for pharmaceutics, biotech, healthcare and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging and drug delivery devices. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer psroduces close to its customers worldwide with around 10,000 employees and generates annual sales of more than €1.4 billion. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.
Hovione offers customized services and innovative solutions from drug substance to drug product, with all activities performed at the same site. Hovione provides a fully integrated service for clinical and small commercial scale complex drug product development and manufacturing as well as formulation development for highly sophisticated inhalation and other formulations both for small molecules and biologics. As the Leader in Commercial Spray Drying, Hovione can handle projects from early-phase development to commercial and accelerates your time to market. Our particle engineering technologies can address challenges in solubility enhancement, lung delivery, modified release and taste-masking applications and can handle highly potent compounds. For biopharmaceuticals Hovione is investing by partnering in specialized particle engineering technologies, namely spray drying, aseptic spray freeze drying, nanoparticles and microemulsions. We do well what is difficult, to give our customers what they cannot find elsewhere
InnoGI Technologies (formerly The TIM Company) provides innovative CRO services to the Pharmaceutical Industry related to Gastrointestinal (GI) research and Oral Drug Delivery. It utilizes the most advanced and accurate gastrointestinal technology, mimicking the dynamics of a real human gut (SurroGUT™).
Our SurroGUT™ platform offers the TIM systems, a technology that is able to mimic the human GI tract with a correlation range of 76% to 99.9% with human formulation rankings. This innovative solution provides enhanced predictive capabilities, aiming to improve the overall probability of success, also in preparation for clinical trials.
InnoGI Technologies, headquartered in Delft, The Netherlands, offers a range of research services addressing complex formulation issues in oral drug candidates which can lead to decreased formulation iterations, effectively de-risked clinical trials, and shortened time-to-market. InnoGI Technologies is driven by the goal of developing innovative technologies and solutions related to realistic GI tract simulations and oral drug delivery for Pharma and Food.
Integra offers extensive expertise in collagen, collagen composite biomaterials and neurosurgery products for companies seeking drug delivery strategic alliances. Our collagen products are manufactured from bovine deep flexor tendon, one of the purest sources of Type I collagen available, with biocompatibility and safety demonstrated in over 10 million implants (neurosurgery, plastic and reconstructive surgery, and orthopedic surgery).
Integra is a recognized and respected industry leader with vast experience in developing innovative regenerative medicine products with a wide array of applications including dental applications, sports medicine, bone grafting materials, reconstructive wound healing, hemostasis and carrier technologies for drug and protein delivery.
Integra is compliant with ISO 13485:2016, FDA Quality Systems Regulations and the EU 2017/745 Medical Device Regulations. Our wealth of experience in design control, testing requirements, manufacturing, quality systems, and the regulatory approval process make us a powerful partner to companies seeking private label partnership.
Leukocare is a formulation development partner specializing in biologics, applying bioinformatics-driven preselection and empirical design to develop molecule-specific solutions. Our proprietary, data-guided approach accelerates identification of excipients and formulation parameters, reducing timelines and conserving drug substance.
Lonza is one of the world’s largest healthcare manufacturing organizations. Working across five continents, our global community of approximately 18,500 colleagues helps pharmaceutical, biotech and nutrition companies to bring their treatments to market. We support our customers with a combination of technological insight, world-class manufacturing, scientific expertise, process excellence and innovation. Our work enables our customers to develop and commercialize their therapeutic discoveries, allowing their patients to benefit from life-saving and life-enhancing treatments.
Lubrizol provides excipients that enhance the solubility and bioavailability of active ingredients. Apinovex™ Polymers are used for amorphous solid dispersions, improving the solubility of poorly soluble drugs. Apisolex™ Polymers enhance solubility in injectable formulations, offering high drug loading and stability.
Carbopol® Polymers are high molecular weight polyacrylic acid polymers used in various formulations for their thickening and stabilizing properties. We also supply a range of other ingredients listed on the FDA’s Inactive Ingredient Database (IID) that can help improve the feel and performance of topical pharmaceutical formulations.
Nanoform is an innovative nanoparticle medicine-enabling company that works together with global Pharma and biotech partners to devise solutions to complex formulation challenges. Nanoform’s multi-patented and scalable Controlled Expansion of Supercritical Solutions (CESS®) process can produce uniform nanoparticles as small as 10nm, facilitating transport even across biological barriers. As particles smaller than 100nm have significantly enhanced surface areas, this can increase drug dissolution rates and improve bioavailability, allowing drugs of poor solubility in the pharmaceutical pipeline to progress to clinical development. CESS® enables lower dosage and safer products to be developed with reduced side-effects and permits combination therapies, which would otherwise be prohibited by the large dosages of either drug. The award-winning technology is also ushering in a new era of ocular, pulmonary and transdermal drug delivery applications, along with enhanced delivery of drug particles across the blood-brain barrier.
Nisso Chemical Europe offers NISSO HPC, a high-quality excipient for the pharmaceutical industry providing hydroxypropyl cellulose in a wide range of viscosities and particle sizes for diverse applications, offering solutions for direct compression, roller compaction, wet granulation, drug solubility enhancement (amorphous solid dispersions, nanosuspensions), supersaturation stabilizer, controlled release hydrophilic matrix systems, 3D tablet printing, extrusion, orodispersible tablets, injectables, and film coating.
Pfanstiehl Inc. is a cGMP Manufacturer of High Purity Low Endotoxin components such as Trehalose, Sucrose, Mannitol, Maltose, Galactose (non-animal), Mannose and Amino Acids such as L-Arginine, Histidine, Glutamine and Methionine for Biologics, Biosimilars, Vaccines, Cell Culture Media and Injectables (liquid & lyo) located in Waukegan Illinois USA. Pfanstiehl has been in operation since 1919, focusing on both Biopharmaceutical excipients / critical components & Pharmaceutical HPAPIs / APIs (generic and on contract manufacturing base). Pfanstiehl specializes in isolation, purification, custom synthesis and scale-up development of regulated, high purity and low endotoxin Injectable Formulation Ingredients, Pharmaceutical Intermediates and Active Pharmaceutical Ingredients, in gram to multi-ton commercial quantities.
Pion Inc. offers unique instruments and services for informed drug and food formulation decisions, spanning R&D to manufacturing. Pioneering in vitro to in vivo tools, we optimize drug development and provide insights for pharmaceuticals and biopharmaceuticals. Our mission: expedite drug development, serving a global market with two decades of trusted expertise. Headquartered in Massachusetts, USA, and a UK office for global reach, Pion Inc. advances pharmaceuticals through innovation.
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.
Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, molecules need to become cures, fast. Because humanity needs solutions, fast.
Serán BioScience, LLC is a leading sci¬ence-based CDMO that specializes in a variety of drug delivery and formu¬lation approaches suited to optimizing bioavailability. Serán’s experienced formulation team will work with you to identify an appropriate technology and formulation strategy to meet your program’s unique needs. Our comprehensive approach to formulation design considers the physiochemical properties of the API, the target product profile, and your program’s objectives and constraints to develop scalable formulations using efficient and material-sparing approaches.
Whether considering enabling technologies (amorphous solid dispersions, lipid formulations, particle size reduction techniques) or conventional approaches, we comprehensively assess technology options to consider bio-performance, stability, manufacturability, and drug product design – aiming to deliver you the simplest approach that meets your program’s needs.
Serán provides capsules (enteric or IR), tablets (from minitablets to large format caplets), multi-particulates (coated beads), and powder-in-bottle formulations. Our solid dosage forms are engineered for a wide range of formulation approaches such as overcoming solubility challenges and to enable extended-release. We complement industry-best production practices with the finest manufacturing equipment available to produce dosage forms that perform predictably and reliably.
Founded in 1949, Stevanato Group is a leading global provider ofdrug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. TheGroup delivers an integrated, end-to-end portfolio of products,processes and services that address customer needs across the entire drug lifecycle at each of the development, clinical andcommercial stages. Stevanato Group’s core capabilities in scientificresearch and development, its commitment to technical innovationand its engineering excellence are central to its ability to offer value-added solutions to clients.
Triclinic Labs is a premier contract research organization focused on solid-state chemical development and comprehensive materials analysis for pharmaceutical, medical device, and fine-chemical clients. Leveraging decades of experience, the company excels in polymorph and salt, form screening and selection, cocrystal screening and formulation, and amorphous material development, as well as crystallization method optimization and particle/habit engineering.Their state-of-the-art analytical chemistry services encompass X-ray powder diffraction (XRPD), Electron and single crystal diffraction, thermal analysis (TGA/DSC), spectroscopy (Raman, FT-IR, solid-state NMR), chromatography (LC/GC), microscopy (optical, electron, high-speed), Coupled techniques (Mass spectrometry with LC and GC), elemental analysis (EDX, ICP-MS), water content determination (KF, DVS), and particle-size characterization. Advanced offerings include predictive materials modeling, peptide characterization, and specialty inorganic, petrochemical, and contaminant identification analyses.As a cGMP-compliant, DEA Schedule I–V registered and FDA-inspected laboratory, Triclinic Labs provides method development, validation, and release testing, robust intellectual property support, and regulatory guidance to accelerate timelines and mitigate development risks. Their integrated approach ensures clients achieve reproducible, scalable solutions with maximum efficiency and confidence.
Uncountable provides a Unified R&D Laboratory Informatics Platform that revolutionizes how R&D teams explore, analyze, and share scientific data, helping accelerate the pace of innovation. Founded in 2016, Uncountable's all-in-one AI-powered solution helps enterprise R&D organizations modernize and streamline data management and analysis – providing scientists with a single and easily accessible web-based platform that comes fully integrated with all the critical data systems and tools used in the laboratory, including electronic lab notebooks (ELNs), laboratory information management systems (LIMS), product lifecycle management (PLM), quality management systems (QMS), advanced visualization and reporting tools, and more.
WuXi STA, an integrated part of WuXi AppTec, is an industry-leading pharmaceutical development and manufacturing capability and technology platform serving the life sciences industry with operations across North America, Europe and Asia. As an innovative Contract Development, and Manufacturing Organization (CDMO) for small molecule new drug development, WuXi STA offers our worldwide partners efficient, flexible, and high-quality solutions from preclinical to commercial uses.
Zerion Pharma A/S is a pharmaceutical company aspiring to transform the pharmaceutical landscape for the formulation of poorly soluble drugs that are currently not reaching their therapeutic potential.
The company was established in 2019 as a spinout from the University of Copenhagen based on a decade of research. Zerion Pharma has pioneered the Dispersome® technology that greatly enhances the solubility of poorly soluble, oral drugs and improves bioavailability and therapeutic options for patients.
The Dispersome® technology is based around a class of novel excipient, namely beta-lactoglobulin (BLG), to formulate poorly soluble small molecule drugs into stable amorphous drug delivery systems with a high drug load. By increasing solubility and dissolution rate, the Dispersome® platform aims at improving bioavailability and therapeutic outcomes and reducing adverse effects in patients. The Dispersome® technology is well accepted with no safety risks and is compatible with standard solid oral dosage form manufacturing.