Commercial Partners

Adare Pharmaceuticals


Adare is a global specialty pharmaceutical company inspired to create new possibilities for patients whose treatment needs are not fully addressed by current medications. With a growing pipeline, focused R&D efforts, and global manufacturing capabilities, Adare is actively exploring value creation through development and expansion across therapeutic areas. Adare has a proven track record from concept through commercialization that can help you overcome formulation challenges and add valuable IP to your current and future products. Formulation challenges? Experience a partnership focused on the needs of patients and your company’s goals, contact us at BusDevROW@adarepharma.com


www.adarepharma.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

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

Datwyler Pharma Packaging International


Datwyler Sealing Solutions is a leading industrial supplier and a key player in the global health care 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, 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 all patient’s safety and improve patients’ lives.


www.datwyler.com

DFE Pharma


DFE Pharma is the global leader in excipient solutions. We develop, produce and market excipients for oral solid dose and dry powder formulations with a heritage in lactose, starch and superdisintegrants. With the addition of MCC to our portfolio DFE Pharma uniquely offers world's main excipient categories, unlocking potential synergies for you to increase your efficiency. Contact us on www.dfepharma.com


www.dfepharma.com

Dow Pharma & Medical


Dow Pharma & Medical is a global leader in research, manufacturing and innovation of functional excipients, API’s and silicon-based technologies for medical device fabrication and pharmaceutical processing. It has the material science expertise and global market and regulatory experience to help customers deliver innovative solutions for healthcare challenges of today and tomorrow; bringing new products to market faster and extending product life-cycles. Whether you are creating modified release medicines, seeking to enhance the solubility of Active Pharmaceutical Ingredients for therapeutic effect, or simply looking for efficient wound care through soft skin adhesives, we can take you there. Dow will highlight specific solutions on solubility enhancement: – New possibilities using AFFINISOL™ excipients – exploring a platform of tailored polymers for solubility enhancement Well-known brands for: Solubility Enhancement Modified Release Taste Masking Tablet or Enteric Coating Binders Stabilizers Rheology Modifiers Adhesives Antifoams and Antifoam Simethicone Emulsions Fluids, Emulsions and Dispersions Topical Excipients Topical Ingredients Rubber and Elastomers Tubing and Molded Assemblies


www.dowpharmasolutions.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

Hovione


Hovione offers customized services and innovative solutions from drug substance to drug product, with all activities performed at the same site, providing a fully integrated service for clinical and small commercial scale complex drug product development and manufacturing. As the Leader in Commercial Spray Drying, Hovione can handle projects from development 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. Hovione also offers integrated inhalation development services. We do well what is difficult, to give our customers what they cannot find elsewhere.


www.hovione.com

Losan Pharma


70% of the NCE´s have a certain problem (solubility, stability, bioavailability, variability) which limits their potential use. Losan is a privately owned company and has beside the conventional technologies a broad platform for innovative technologies like (i) Solubilisation technologies such as Nanoparticulate , HME-based or Amorphous Silica formulations with proven in-vivo results, (ii) Pellet/Coating technology for target release formulations (iii) Stick pack technology for high dose and convenience application (iv) OTC innovations. Our strategy is to help companies with the design and solutions of their specific API formulations needs. A strong analytical support (DoE, QbD, ivivc correlation,) completes our approach.


www.losan-pharma.de

LTS Lohmann


LTS is the global leader in the development and manufacture of transdermal systems and oral thin films with additional innovative technologies in development. The products developed by LTS comprise a multitude of innovations, such as first and only patch for treatment of Alzheimer and the only patch against Parkinson’s and Restless-Legs-Syndrome, which is the first medication in the world available only as a patch. The innovation capability of LTS led the way for oral thin film products on the market with the introduction of Listerine® Pocketpaks®, which dominate the North American market. LTS supports its cooperation partners from product inception through commercialization in our FDA approved facilities in Germany and USA. More than 3,000 patents reinforce the top position of LTS group in development of its technologies. LTS Lohmann services include: Feasibility studies Full product development Clinical studies phase I-IV Scale-up and process development Commercial manufacturing For transdermal therapeutic systems, topical patches and oral thin films (OTF)


www.ltslohmann.de

Munit


MUNIT is a new and innovative consultancy company, operating in the field of MICRONIZATION of Active Pharmaceutical Ingredients (APIs), High Potent APIs, Cytotoxic and Cytostatic compounds, Inhalation products, Steroids, R&D compounds and Generics. In MUNIT we have combined the technical and commercial expertise of its affiliates Jetpharma SA (Switzerland) and Microchem Srl (Italy) making the best out of 40 years of leadership. MUNIT is your direct access point to Jetpharma’s and Microchem’s services, such as: Jet- , Pin- and Hammer milling Co- and cryogenic micronization Sieving, Blending, De-Lumping Technical trials, DOE Studies, Process development and validation PSD analysis etc.


www.munit.com

Pfanstiehl Inc.


Pfanstiehl Inc. is a cGMP Manufacturer of High Purity Low Endotoxin components such as Trehalose, Sucrose, Mannitol, Maltose, Galactose (non-animal), Mannose and Ribose 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.


www.pfanstiehl.com

Quotient Sciences


Quotient Sciences is 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.


www.quotientsciences.com

Roquette


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

Shin-Etsu Pharma & Food Materials Distribution GmbH


Shin-Etsu PFMD is the distribution organization of Shin-Etsu Chemical Co., Ltd. Japan and SE Tylose, Wiesbaden Germany and is registered in Wiesbaden. It is located at the Industrial Park Kalle-Albert in Wiesbaden. Together with our distributors, we are the exclusive business partners for our customers and multi national key accounts in the pharmaceutical- and the food industry. SE PFMD manages a regional, centralized warehouse for all products to be able to supply the customers in Europe on short-term base whenever necessary. SE PFMD will manage logistic for customers in other regions independent from Shin-Etsu´s production sites. For our pharma customers we offer with our technical application lab the possibility to optimize their processes if required. Our products are covering a very wide range of applications and they fully comply with FDA, USP/NF, JP and EP requirements. Pharmaceutical Excipients: Cellulose ether excipient is a pharmacologically inactive substance used as a carrier for the active ingredients in medication. PHARMACOAT® – Water-Soluble Film Coating Agent METOLOSE® – Binder and Thickening Agent METOLOSE® SR – Sustained release agent for hydrophilic matrix system L-HPC – Disintegrant with Binding Properties, Multifunctional Excipient HPMCP – Enteric Coating Agent Shin-Etsu AQOAT® – Enteric Coating Agent, Solid Dispersion Polymer Tylopur® – Low- and high viscosity Hypromellose


www.se-pfmd.com

W. L. Gore & Associates


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