Commercial Partners 2018

Commercial Partners 2018

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

ADM-SIO

ADM-SIO is a global leading manufacturer of pharmaceutical grade oils (soybean, olive, sesame) used as API’s or excipients for oil-soluble drugs. As a subsidiary of Archer Daniels Midland Company (ADM) –– ADM-SIO offers an extensive range of highly purified oils, derived from vegetable origins that meet all relevant pharmaceutical regulations and manufactured according to cGMP standards. Our highly purified pharmaceutical oils are used as API’s (CEP for soybean and olive oils) in large volume emulsions for parenteral nutrition and as excipients (US DMF type IV for soybean, olive and sesame oils) in injectable, oral or topical formulations.

www.admsio.com

Agilent Technologies
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

Aplicaps
Armor Pharma
Biopharma Group

Biopharma Group is a leading supplier of equipment and analytical services to the pharmaceutical, biotech and process industries for those using freeze drying technology, solvent removal/evaporation, high pressure homogenisation and industry related equipment. Our group compromises of dedicated divisions for:

  • Sale and service of freeze drying and associated equipment throughout the UK, Ireland & France
  • Independent R&D, analysis, analytical instrument, training, product & cycle development consultancy division that services an international client base
  • Freeze drying equipment sales and consultancy services exclusively for our French speaking clients
  • A dedicated USA division for R&D/analysis services, analytical instruments and freeze drying technology training requirements.

www.biopharma.co.uk

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.

www.dfepharma.com

DuPont Nutrition & Health

With combined decades of technical and industry expertise, DuPont, Dow, and FMC are unifying their product offerings, which service the food, pharmaceutical, and nutraceutical markets under the name DuPont Nutrition & Health. This newly combined portfolio addresses the toughest challenges its customers face in pharmaceutical applications, drug delivery systems, and productivity enhancement.

www.dupont.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

FreeThink Technologies
Grace

Grace, built on talent, technology and trust, is a premier specialty chemicals company that provides innovative products, technologies and services that support pharmaceutical development and manufacturing. As a worldwide leader in specialty silica gel manufacturing, Grace’s portfolio of solutions for the pharmaceutical industry include SYLOID® formulation excipients, SILSOL® silica-based drug delivery technologies, custom intermediates and regulatory starting materials, and VYDAC® and DAVISIL® bulk chromatographic resins.

www.grace.com

Harke Pharma
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

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

Lonza Pharma & 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.pharma.lonza.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

Medical Device Usability
Meggle Excipients & Technology
Merck KGaA

Merck KGaA, Darmstadt, Germany is a leading science and technology company in healthcare, life science and performance materials. We offer more than 400 pharmaceutical formulation raw materials for solid, liquid and semi-solid dosage forms, a wide range of active pharmaceutical ingredients and drug delivery compounds which include activated PEGs, lipids, PEG lipids for bioavailability enhancement. In addition, our Emprove® Program provides extensive regulatory documentation to facilitate risk assessment and qualification processes. Through dedicated collaboration on new scientific and engineering insights, we serve as a strategic partner to help advance the promise of life saving therapies.

www.merckgroup.com

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

Nanoform
Patheon

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.

www.patheon.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

PMC Isochem

PMC Isochem offers contract research, custom manufacturing, catalogue products and innovative solutions for Pharmaceutical companies worldwide. Our offer addresses three major areas:

  • Drug delivery vehicles: TPGS-1000 NF USP for poorly soluble drug formulation and Polypeptides based solution for Nano Encapsulation and Polymer Drug Conjugates
  • CDMO services: GMP industrial exclusive custom synthesis and provides tailor made services from development to production. 3 FDA audited manufacturing plants
  • Generic APIs: 20 generic API  for US, EU and worldwide market

www.pmcisochem.fr

Portal Instruments
Precision Nanosystems
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

Renishaw

Renishaw is one of the world's leading engineering and scientific technology companies, with expertise in precision measurement and healthcare. The company supplies products and services used in applications as diverse as jet engine and wind turbine manufacture, through to 3D printing, dentistry and brain surgery.
The Renishaw Group currently has more than 70 offices in 35 countries, with over 4,000 employees, of which 2,800 people are employed within the UK. For the year ended June 2017 Renishaw achieved sales of £536.8 million of which 95% was due to exports. The company's largest markets are China, USA, Germany and Japan.

www.renishaw.com

REVOX Sterilization Solutions
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

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

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