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.

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™ Technology
The 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.

Cambridge Consultants develops breakthrough products, services and intellectual property, and provides business consultancy in technology-critical issues for clients worldwide. For more than 60 years, the company has been helping its clients turn business opportunities into commercial successes, whether they are launching first-to-market products, entering new markets or expanding existing markets through the introduction of new technologies.

The team of more than 800 engineers, scientists, mathematicians and designers has an unparalleled track record in creating medical technology solutions that disrupt markets and revolutionize healthcare. These range from parenteral delivery devices such as pens, autoinjectors, patch pumps and large volume injectors through to medical implants and surgical drug delivery systems. The team has also pioneered high functionality, user-centred electromechanical devices combining drug delivery with wireless connectivity and eHealth service solutions to enable patient engagement and adherence.

With offices in Cambridge (UK), Boston (USA), Tokyo (Japan) and Singapore, Cambridge Consultants offers solutions across a diverse range of industries including medical technology, industrial and consumer products, digital health, energy and wireless communications.

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.

Conscio group is a European and vertically integrated Contract R&D and Manufacturing organization offering complete and innovative solutions from the idea to product. Our services include PoC, formulation and process development, manufacturing and release of IMPs & registration batches , clinical trials in our own Phase I units and (bio)analytical services. We focus on hard-to-make formulations and technologies (including high potents & narcotics) for solid, semi-solid, liquid drug products, transdermal delivery systems (TDS), oral thin films (ODF) and personalized medicine via 2D/3D printing. Our customers receive solutions tailored to their exact needs. Due to the vast pharmaceutical and technological expertise of our teams, we can de-risk development projects and accelerate time-to-market. Headquartered in Munich, Conscio Group members include Gen-Plus (Germany), Quinta-Analytica (Czech Republic), LVA (Austria), EL Labs (Slovakia), HyServe (Germany) and a representative office in the USA.

Capabilities:
•Innovation & Drug Product: Pharmaceutical R&D, feasibility, PoC, formulation and process development, scale-up, material science, permeation studies on tissue and artificial systems.
•Quality Control of Pharmaceuticals: Analytical method development and validation, GMP quality control, batch release testing, stability studies per ICH, microbiology testing, HAPIs, API sourcing.
•Quality Control of Biopharmaceuticals: Bioanalytical method development and validation, GLP/GMP bioanalysis, CMC, characterization of peptides, protein, ADCs and biosimilars.
•Clinical Solutions – Clinical Trials: 2 clinical units with a capacity for 60+36 beds, BE/BA/PK studies – planning, design and execution.
•Clinical Solutions – Bioanalysis: GLP/GCP solutions for preclinical & clinical studies, small & large molecules, statistical evaluation.
•Manufacturing solutions: cGMP-certified manufacturing of IMP clinical batches and registration batches.

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.

Sensile Medical develops on- and off-body worn liquid drug delivery devices. Our technology offers a highly customizable, safe and cost-efficient device platform for small and large volumes. The micro-infusion pumps enable highly precise dosing at variable delivery patterns and offer various opportunities to inject a drug without the need of changing the primary packaging. Our proficiencies range from design to industrialization including manufacturing, digital health solutions. The first pump for the treatment of Parkinson`s disease was launched by EVER Pharma in 2019. Sensile Medical is a Swiss company established in 2004 and a subsidiary of Gerresheimer AG since 2018.

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.

At Lonza Pharma & Biotech, we provide contract development and manufacturing services that enable pharma and biotech companies to bring medicines to patients in need. From the building blocks of life to the final drug product, our solutions are created to simplify your outsourcing experience and provide a reliable outcome, at the time when you expect it. Our extensive track record includes commercialization of pioneering therapies and manufacturing of a wide variety of biological and chemical drugs. We continuously invest to solve not just current, but also future challenges. Together, we can bring your next medicine to life.

Lubrizol Life Science – Health partners with medical device, pharmaceutical and nutraceutical companies to develop innovative solutions that improve patient outcomes and consumer benefits.

As an integrated solution provider, we co-develop solutions with our customers from concept to commercialization. Along with our best-in-class medical polymers, pharmaceutical excipients, and nutraceutical actives, we offer our design & development expertise, and advanced global manufacturing capabilities to enable your development and to accelerate your innovations to market.

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 HPC (Hydroxypropyl Cellulose) was first sold in Japan in 1969 and is globally approved for use as a pharmaceutical and nutraceutical excipient and as a binder for granulation, direct compression, and as a solubility enhancement matrix. NISSO HPC has been fully IPEC GMP compliant since 2010.

NISSO SSF (Sodium Stearyl Fumarate) is a lubricant (pharmaceutical additive) in the production of tablets. It is primarily used in tableting and dry granulation as a means of preventing tablet failure. The presence of hydrophilic groups in the molecule improves the disintegration time of the tablets, making it suitable for use in orally disintegrating (OD) tablets. Using NISSO SSF as a lubricant can suppress the effects of over-mixing tableting powders and improving the tablets physical properties, making it suitable for the continuous pharmaceutical manufacturing that has been gaining attention in recent years.

Nippon Soda/NISSO provides Japanese high-quality and highly functional excipients.

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.

Quotient Sciences is a drug development services organization, dedicated to accelerating the development of new drugs for patients around the world. We provide formulation development, clinical pharmacology trials, and clinical and commercial manufacturing services to the pharmaceutical and biotech industry. These services are provided either individually or as an integrated service offering via our Translational Pharmaceutics® platform, which is proven to shorten development timelines and reduce associated costs.

QPharma, Foster Delivery Science and Disphar International are now Sever Pharma Solutions. Together we have formed a new CDMO, a company that can provide our customers with unique capabilities and expertise. Sever Pharma Solutions brings your pharmaceutical ideas to life by offering expertise in high potent drug development, a drive to enhance performance, a passion for perfection, and a commitment to be your partner through the whole journey. We can enhance your reach by ensuring that your products can benefit patients all over the world. We can enhance your efficiency by providing you with a complete value chain to offer you an optimized end-to-end solution. We can enhance your product by adding value through all development and manufacturing processes. We can enhance your outcome by adding value through all development and manufacturing processes. We are Extrusion. We are Polymer Based Dosage Forms. We are Formulation of Highly Active dosage forms. We are Long Acting Implants. We are Solid Dosage Forms. We are Injection Molding. We are Aseptic Fill and Finish. We are Sever Pharma Solutions.

WuXi STA, a subsidiary of WuXi AppTec, is a leading CRDMO providing integrated CMC services including both API and drug product for small molecule, oligonucleotide, peptide and complex conjugate from discovery to development and commercial manufacturing.

WuXi STA has 14 R&D and manufacturing sites across Asia, North America and Europe. Our comprehensive drug product platform has a strong R&D team of 1,500+ scientists with capabilities in broad oral and parenteral dosage forms. Our bioavailability enhancement technology platform includes spray-dried dispersion, hot melt extrusion, nano suspension, softgel & liquid filled hard capsules.