Commercial Partners

If you are interested in sponsoring the American Drug Delivery & Formulation Summit, please contact:

Alexandra Krcho
Account Director
+ 44 (0)20 3874 9205
alexandra.krcho@markallengroup.com

2022 Commercial Partners

Adare Pharma Solutions

Adare Pharma Solutions is a global technology-driven CDMO providing end-to-end integrated services, from product development through commercial manufacturing and packaging, with expertise in complex oral formulations. Adare’s specialized technology platforms provide taste masking, controlled release, solubility enhancement, and patient-centric dosing solutions. With a proven history in drug delivery, Adare's seven facilities in the US and Europe has developed and manufactures more than 45 products sold by customers worldwide.

www.adarepharmasolutions.com

Amneal Pharmaceuticals

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of approximately 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets.

www.amneal.com

Aragen

Aragen Life Sciences is a leading R&D and manufacturing solutions provider for the life sciences industries worldwide. Aragen offers end-to-end integrated or standalone solutions to advance small and large molecule programs from concept to commercialization. Established in 2001, the Company operates through a global network of six sites with a team of 3800+ employees and 450+ PhDs. Its expertise and experience have enabled over 450 customers (including 7 of the top 10 pharma companies globally) in advancing their research programs from early discovery through development and commercialization. Aragen’s innovative mindset, infrastructure, flexible business models, a clear purpose, and proprietary project management platform have enabled it to effectively scale and service large pharma, biotech, agrochemical, and animal health industries globally.

www.aragen.com

Ashland

Ashland works alongside formulators to advance drug-specific delivery platforms with an industry-leading portfolio of pharmaceutical excipients and technical expertise including superior polymer technology and systems for optimum bioavailability.

For over 50 years, Ashland has created value for customers through applications knowledge, technical support, and a powerful product portfolio. The company offers real-time solutions based on superior binder, film coating, solubilizer, disintegrant, rheology control, cyclodextrins and modified-release technologies.

A team of technical experts at global R&D centers provide formulation development support for conventional and potent compounds as well as controlled substances to offer tailored solutions that address solubility challenges.

During this event, Ashland will showcase polymer solutions for extended release injectable depot strategies including ViatelTM bioresorbable polymers. This portfolio includes 72 GMP grades of lactide, glycolide and caprolactone copolymers as well as a customized polymer platform which supports formulators to solve complex processing, stability and delivery challenges.

www.ashland.com

Calusa Bio

Calusa Bio has developed a novel excipient to minimize protein aggregation in biologic drug products.  Protein aggregation is a concern during throughout the manufacturing and use of current biological drug products that can impact shelf-life, drug performance, and patient safety.  Existing surfactants, including polysorbates, offer improvement, but introduce new concerns related to the PEG-based excipient.  Our solution is free of PEG and improves the stability of proteins in a variety of stressed conditions when compared to polysorbates.  This polysarcosine based excipient offers a marked improved solution to attenuate aggregation in these highly-valuable protein drug products.

Cambridge Consultants

Cambridge Consultants, part of Capgemini Invent, develops breakthrough products and services, creates and licenses intellectual property, and provides business consultancy in technology-critical issues for clients worldwide.

For more than 60 years, we’ve helped our 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. 

With a team of more than 900 staff, in offices in Cambridge (UK), Boston (USA), Tokyo and Singapore, Cambridge Consultants offers solutions across a diverse range of industries including medical and life science, industrial and energy, consumer and retail, and communications and infrastructure.

In 2021, Cambridge Consultants became part of Capgemini Invent.

www.cambridgeconsultants.com

Captisol

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 Gilead Sciences' VEKLURY®, Amgen’s KYPROLIS®, Baxter International’s NEXTERONE®, Acrotech Biopharma L.L.C.’s and CASI Pharmaceuticals’ EVOMELA®, Melinta Therapeutics’ BAXDELA™ and Sage Therapeutics’ ZULRESSO™.

There are many Captisol-enabled products currently in various stages of development. Ligand maintains a broad global patent portfolio for Captisol with more than 400 issued patents worldwide relating to the technology (including over 40 in the U.S.) and with the latest expiration date in 2033. Other patent applications covering methods of making Captisol, if issued, extend to 2040.

www.captisol.com

Catalent

Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance, and ensuring reliable global clinical and commercial product supply.

www.catalent.com

Celanese

Celanese offers the VitalDose® Drug Delivery Platform, providing long-acting controlled release of small molecules, biologics, and RNAi 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, or visit us during the event at booth #11.

www.vitaldose.com

Corbion

Corbion is a leading resorbable polymers supplier for medical implant device manufacturers and drug delivery formulations. We empower customers to grow by working side by side with you in making conscious choices in medical applications and inspiring to create patient friendly solutions with reduced healthcare costs to help improve patients’ lives.

Corbion Biomaterials develops, manufactures and markets lactide and glycolide monomers and resorbable (co)polymers based on lactide, glycolide and caprolactone worldwide under the PURASORB® brand name. These polymers can be manufactured with any of the lactide isomers (L, D or DL). You can start your project assured that our polymers have already proven themselves as they are used extensively in pharmaceutical applications and controlled drug delivery systems. We support your developments with our products from early stage R&D to commercial manufacturing.

We invite you to contact us and find out how our 40+ years of experience can be of value to your business.

www.corbion.com/biomedical

Croda Pharma

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.

www.crodapharma.com

Datwyler

Datwyler Sealing Solutions is a leading industrial supplier and a key player in the global healthcare world. Our state-of-the-art solutions for drug packaging and medical devices, build on over 100 years of experience. Within our healthcare offering, we provide a unique range of products and services including the most advanced elastomer formulations, coatings, aluminum seals, and processing technologies. Partnering up with the world’s top pharmaceutical and medical companies, we are a vital link and stand by our mission to ensure patient s’ safety and improve patients’ lives.

www.datwyler.com

EdgeOne Medical

Pharma knows drug development; EdgeOne Medical knows device development

Even in 2022 Pharma resources are overwhelmingly focused on drug development and continue to put a lot of pressure on a comparatively smaller but growing internal device development capability.  EdgeOne Medical has been the key partner supporting eight of the top 25 Global Pharma with their device development programs and associated challenges.

Since 2012, EdgeOne Medical has been the only purpose-built and independent Contract Device Development Organization (CDDO) for Pharma that has operated proprietary ISO 13485 certified Device Testing Labs supported by Product Development, Regulatory and Quality professionals to help navigate, accelerate and, for some firms, execute Pharma Device Development Programs.  

Whether your Combination Product is Drug/Device or Drug/Digital—EdgeOne Medical is the most experienced and successful partner in getting Pharma device systems compliantly on the market and stay there from Strategy to program execution.  Zero 483s; 100’s of successful TMVs and Test Studies in our labs to support the Device File submission we can support or author.

www.edgeonemedical.com

Gerresheimer

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.

www.gerresheimer.com

Hovione

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.

www.hovione.com

Lonza

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.

www.pharma.lonza.com

Lubrizol Life Science Health

The Health business team at Lubrizol Life Science partners with customers to speed their innovative medical devices and differentiated pharmaceutical products to market. Our dedicated team provides best-in-class polymers and excipients, along with state-of-the-art product design, development, and manufacturing services, with the ultimate goal of creating solutions that improve patient outcomes. Driven by innovation, powered by partnership.

www.lubrizol.com

MilliporeSigma

MilliporeSigma, a life science leader, is a business of Merck KGaA, Darmstadt, Germany providing pharma and biopharma companies with SAFC® products and services for drug development and manufacturing. We offer excipients and APIs for all final dosage form and contract manufacturing services to support all drug manufacturing process stages.

www.sigmaaldrich.com

MUNIT SA

MUNIT and its affiliates JETPHARMA and MICROCHEM operates in the field of MICRONIZATION and MILLING of Active Pharmaceutical Ingredients (APIs), High-Potent-APIs, Cytotoxic- and Cytostatic- compounds, Inhalation products, Steroids, R&D compounds and Generics.

Our services:

·       Jet- , Pin- and Hammer milling
·       Cryogenic-Micronization
·       Co-Micronization
·       Post-milling conditioning
·       Sieving, Blending, De-Lumping
·       Technical trials, DoE Studies,  Process-development and Validation
·       QbD
·       PSD analysis etc.

The triangular company structure with its back-up potential, its technology transfer and the resulting flexibility is one of our unique features in the market (Business continuity).

MUNIT guarantees best service, high efficiency and punctuality to customers worldwide.

www.munit.com

MyBiotech

MyBiotech is a CDMO specialized on development and technology transfer of nanoparticle and microparticle formulations from concept through development all the way up to GMP manufacturing. Our long years of experience in particle development and analyses of liposomes, inorganic particles, polymeric particles, crystalline particles, solid lipid nanoparticles is reflected into efficient development strategies. With our experienced team we understand the challenges in pharmaceutical development and use them for our advantage to make sure particulate systems meet your specific formulation needs. We are continuously developing and adapting innovative production methods for GMP manufacturing and processing of particulate systems. We support you with our innovative technologies to bring your project one step closer to success.

www.mybiotech.de

Nanoform

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.

www.nanoform.com

NanoImaging Services

Having a clear picture of nanomedicine formulations like vaccine, gene, and drug delivery vehicles can mitigate the risk for unexpected complications. Cryo-EM simultaneously assesses drug encapsulation, morphology, uniformity, lamellarity, impurities, integrity, and aggregation, and is a powerful, orthogonal technique in any analytical toolkit. NIS provides rapid, flexible and cost-effective access to cryo-EM with expert knowledge and established infrastructure to accelerate projects and gain a better understanding of your formulations.

www.nanoimagingservices.com

Precision Nanosystems

Precision NanoSystems Inc (PNI) creates innovative solutions for the discovery, development and manufacture of medicines and medical research. PNI’s proprietary NanoAssemblr Platform enables the rapid, reproducible, and scalable manufacture of next generation nanoparticle formulations for the targeted delivery of therapeutic and diagnostic agents to cells and tissues in the body. PNI provides instruments, reagents and services to life sciences researchers, including pharmaceutical companies, and builds strategic collaborations to revolutionize healthcare through nanotechnology.

www.precisionnanosystems.com

Quotient Sciences

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.

www.quotientsciences.com

Sever Pharma Solutions

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.

www.deliveryscience.com

WuXi STA, a subsidiary of WuXi AppTec

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 13 R&D and manufacturing sites across Asia, North America and Europe. Our comprehensive drug product platform has a strong R&D team of 1200+ 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.

www.stapharma.com