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

Unchained Labs


Here’s the deal. We’re all about helping biologics researchers break free from tools that just don’t cut it. Unleashing problem-tackling products that make a huge difference in the real science they do every day. That’s our mantra, our promise and we own it. Key Products: Lunatic – the concentration liberator, Uncle – The first all-in-one biologics stability platform. Hunk – The total solution for quantifying stability. Grunt – The first automated buffer prep and exchange system. Freeslate – The most configurable end-to-end automated workflow solution. Junior – The most configurable benchtop workflow solution.


www.unchainedlabs.com

Dow Pharma Solutions


Dow Pharma Solutions is a leader in global research, manufacturing and innovation of functional excipients as well as APIs for laxatives and colonic lavage, for Hyperkalemia and hypercholesterolemia solutions. Our polymer excipients are designed to help address your delivery challenges in a multitude of dosage forms. Whether you are developing modified release medicines, looking for efficient tablet coating or taste masking, seeking to enhance the solubility of APIs for therapeutic effect or simply preventing abuse, we can take you there through leveraging our diverse polymer science, functional design and scale-up capabilities.


www.dowpharmasolutions.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

Foster Delivery Science


Foster Delivery Science focuses solely on Hot Melt Extrusion and extrusion processes to blend client API’s with polymers for several possible purposes: Solubility and bioavailability enhancement; create local delivery solutions such as drug loaded films, implants and fibers; create delivery or release profiles; and capture the powerful mixing capabilities of twin screw extruders. Operating from our new GMP facility 75 minutes from Boston in CT, we provide formulation development services, scale up, clinical trial material and ready for GMP manufacturing.


www.deliveryscience.com

Lonza Pharma and Biotech


Lonza Pharma & Biotech provides global contract development and manufacturing services that enable pharma and biotech companies to bring medical innovations to patients in need. We are recognized for our reliability and high-quality, our global capacity, our innovative technology platforms, and our extensive experience. We have helped to commercialize pioneering therapies and we continuously invest and innovate to meet your expectations also for future medicines. Our belief is that the best outcome –for you and for your patients –comes as a result of a successful collaboration. Together, we can solve the next challenge and bring your next medicine to life.


www.lonza.com

Leon-Nanodrugs


Leon-nanodrugs GmbH (Munich) is a nanotechnology-based drug development company focused on development of novel oral and parenteral formulations and innovative drug combinations. The proprietary and patent-protected MicroJetReactor Technology by leon-nanodrugs is a bottom-up approach for nano- and microparticle synthesis. Basis of the process is a continuous solvent / non-solvent precipitation that is performed under precisely controlled process conditions. Build on its “network of expertise”, leon-nanodrugs can provide a 360 degree competence range – from concept to product approval. Leon-nanodrugs proprietary MJR® Technology offers access to the next generation nano formulated drugs with added patient benefits and economical values for its partners and shareholders.


www.leon-nanodrugs.com

Albumedix


Albumedix® is the market leader in recombinant human albumin and drug-enhancing, albumin-based technologies. As the highest quality recombinant hu¬man albumin ever developed, Albumedix enables the effective formulation of otherwise hard-to-stabilize drugs, cell therapies, and vaccines. Building upon its unique albumin-based, drug-enhancing technologies and a strong, partnered drug pipeline, Albumedix de¬velops proprietary drug candidates that address unmet patient needs. With more than 30 years of experience, and after successfully developing several albumin-enabled drugs in partnership, today Albumedix is dedicated to improving the health of people with serious and chronic diseases.


www.albumedix.com

Roquette


ROQUETTE “Improving well-being by offering the best of nature” A family-owned Group serving customers globally, Roquette is a leader in specialty food ingredients and pharmaceutical excipients. The products and solutions developed by the Group deliver proven technological, nutritional and health benefits precisely tailored to the pharma, nutrition, food and selected industry markets. Roquette’s offer is produced from plant based raw materials such as corn, wheat, potatoes and peas. Since its foundation over 80 years ago, the Group’s growth has been based on innovation, a passion for the job and a commitment to achieve. Roquette operates in over 100 countries, has a turnover of around 3.3 billion euros and currently employs more than 8,000 people worldwide.


www.roquette.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 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.


www.captisol.com

Frontage


Frontage is a full service CRO which closely collaborates with pharmaceutical and biotech companies to help them bring promising drug candidates to market. With 14 locations in USA and China, Frontage has been assisting clients in their drug development efforts since 2001. Spanning from preclinical through late-stage development, its full service offerings include DMPK, Bioanalytical Services for Small and Large Molecule and Biomarkers, CMC, Early Stage Clinical Services and Full Biometrics Support. Frontage also provides turnkey product development services to generic, innovator and consumer health companies to support IND, NDA, ANDA, and 505(b)(2) submissions. What sets us apart is our ability to collaborate closely with our clients to ensure a deep understanding of their drug development goals and our ability provide flexible solutions that are customized to each client’s needs. At Frontage, we are committed to providing rigorous scientific expertise to ensure the highest quality and compliance on each project. Frontage proudly serves innovator, generic and consumer health companies from IND enabling through late stage clinical projects. Frontage successfully assists clients to advance hundreds of molecules through development to commercial launch in global markets. This partnership with our clients is how we turn services into real solutions that get our clients ahead.


www.frontagelab.com

Sonceboz


Our core competencies consist of design, development and production of mechatronic drive systems. Since 1936, our focus has been on innovation, best in class quality and service which is our key to success for worldwide OEM customers. Sonceboz is ISO 13485 certified and active in wearable drug delivery, medical devices and laboratory industry. Pharma companies looking for Large Volume Injectors for high viscosity drugs, Dual Cartridge or Auto-reconstitution Injectors will find interesting solutions in Sonceboz's new drug Delivery Device Platform. Customized technology modules like motor-drives, electronics, pumps and needle insertion systems are available for Medical device manufacturers. Address: Rue Rosselet Challandes - 5 2605 Sonceboz Switzerland


www.medical.sonceboz.com

Patheon, part of Thermo Fisher Scientific


Thermo Fisher Scientific’s Patheon and Fisher Clinical Services brands provide industry-leading solutions for drug development, clinical trial logistics and commercial manufacturing to customers of all sizes. With more than 40 locations around the world, the company can provide integrated, end-to-end capabilities across all phases of development, including API, biologics, formulation, clinical trials solutions and commercial manufacturing.


https://www.patheon.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 health care offering and its three pillars Bio Care, Pharma Care and Med Care, we provide a unique range of products and services including the most advanced elastomer formulations, coatings, aluminium 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 all patient’s safety and improve patients’ lives.


www.datwyler.com

Cambridge Design Partnership


Cambridge Design Partnership is a leading product and technology innovation partner with offices in Cambridge, UK and Palo Alto, USA. We are experienced in drug delivery device design, development, prototype and short-run manufacturing for some of the world’s largest companies. Our experts in engineering, human factors and industrial design are able to take combination products through a full design cycle and submission, to enable you to launch a product that is customer focused and commercially effective. Certified to ISO 13485/9001.


www.cambridge-design.co.uk

W.L. Gore


W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Founded in 1958, Gore has built a reputation for solving complex technical challenges in the most demanding environments — from revolutionizing the outerwear industry with GORE-TEX® fabric to creating medical devices that improve and save lives to enabling new levels of performance in the aerospace, pharmaceutical and mobile electronics markets, among other industries. As a business initiative within the Enterprise, Gore PharmBIO Products develops high-performance, technology-driven products to better serve the global pharmaceutical, bioprocessing and medical device markets. All products in the Gore PharmBIO Products portfolio are tested and manufactured under stringent quality systems. These high-performance products provide creative solutions to our customers’ design, manufacturing, and performance-in-use needs.


www.gore.com/pharmbio

BDD


Profile coming soon


www.bddpharma.com

Solvay


Solvay is a global partner for pharmaceutical companies offering solubilizing, wetting, dispersing, emulsifying agents and tablet manufacturing aids. Solvay, the world's leading supplier of Docusate, manufactures pharmaceutical grade products to the highest quality standards under current good manufacturing practices (cGMP), and is the holder of a USA Drug Master File (DMF) for Docusate. From granulation, to hot-melt extrusion and nano-milling, Solvay has developed functional excipients to support the most challenging solubilization issues.


www.solvay.com

KAER Biotherapeutics


KAER Biotherapeutics’ SUPRAER technology enables rapid aerosol therapy of respiratory conditions with biotherapeutics, antibiotics and anticancer agents within a clinical setting. SUPRAER aerosolizes aqueous viscous (up to 40 cP) solutions/suspensions of high molecular weight entities and efficiently delivers them as pure fine particle (1.5 - 4 microns) solid-phase aerosols at concentrations up to and exceeding 2 mg/l with delivered doses up to 2 gm in 10 minutes. These aerosols in a low pressure gas stream contain 20-30 times the mass of drug per particle compared to similar sized aqueous aerosol. As excipients are not required, formulation costs are reduced and any untoward side effects eliminated. The ability to deliver clinically relevant doses of therapeutics in a short treatment time improves patient and clinician acceptance, reduces personnel costs and leads to better outcomes. KAER’s internal programs are focused on non-invasive surfactant aerosol therapy for patients with respiratory distress precipitated by inadequate surfactant to sustain proper respiratory function - premature babies and patients with acute lung injury. SUPRAER can provide continuous positive airway pressure, CPAP, for neonates and CPAP or bilevel pressure ventilation for adult patients, thus averting the need to interface the device with a separate ventilator. Over 50% of the generated aerosol is administered to the respiratory tract of the patient. SUPRAER technology opens new treatments to patients with pulmonary fibrosis, pneumonia, COPD, atelectasis, cystic fibrosis, severe asthma hospital-acquired lung infections and lung cancer.


http://www.kaerbio.com/