Technology & Services Showcase

Formulation Development
Formulation Development
Latitude Pharmaceuticals, Inc. extends its reputation each day among drug developers as the go-to formulation group for problematic APIs. Whether the need is for a quick PK/Tox formulation or a complete IND-ready formulation development program that covers analytical, manufacturing process, and new IP protection, Latitude draws on its extensive experience and technical expertise to complete each project rapidly, efficiently, and cost effectively. We have the experienced personnel and an extensive range of analytical and manufacturing platforms to develop prototypes of nearly every kind of injectable, oral, topical, inhalation, and ophthalmic human and veterinary formulation – both simple and complex. If your API is insoluble, poorly bioavailable, irritating, physically and/or chemically unstable, tastes bad, requires a special PK or tissue distribution, or requires a proprietary, complex, or generic formulation, contact Latitude at (858) 546-0924, ext 118, or visit www.latitudepharma.com.
Patient-Centric Oral Dosage Forms
Patient-Centric Oral Dosage Forms
Catalent’s customers have access to multiple innovative technologies for oral dose forms that can benefit patients, helping improve patient compliance and reducing the pill-burden for vulnerable patient populations, such as the elderly and chronically ill. Softgel Solutions, including coated softgels, provide optimal drug release profiles through targeted delivery, modified release, and fixed-dose combination. OptiGel™ Bio allows oral delivery of macromolecules, and OptiGel™ Micro technology uses innovative manufacturing processes to produce smaller, spherical capsules. Zydis® Orally Disintegrating Tablets are fast-dissolving tablets that disperse in the mouth, typically in less than 3 seconds and with no water required. OptiShell™ Soft Capsules offer formulators the option of higher fill temperatures in a patented shell derived from plant polysaccharides. For more information, contact Catalent Pharma Solutions at (888) SOLUTION or visit www.catalent.com.
Lyophilization Services
Lyophilization Services
LSNE Contract Manufacturing is a CMO with proven regulatory history, specializing in a wide range of services such as process development, fill/finish and lyophilization. Through the thoughtful integration of three processing facilities, qualified staffing and an extensive manufacturing history, LSNE is strategically positioned to provide uninterrupted material for clinical through commercial supply. LSNE offers both the flexible approach commonly required with R&D scale projects as well as the cGMP framework necessary for late stage clinical and commercial manufacturing. Working with LSNE from development through commercialization reduces your risk while expediting your time to market by avoiding multiple technology transfers. Our flexibility and responsiveness allow us to make your batch our top priority so we can meet your timelines and exceed your expectations. For more information, contact LSNE Contract Manufacturing at (603) 668-5763 or visit www.lyophilization.com.
COP RTF Syringe
COP RTF Syringe
Gerresheimer already offers a range of ready-to-fill COP syringes manufactured by its long-standing partner, Taisei Medical Co. Ltd., in Japan. In this partnership, Gerresheimer’s role is to market the ClearJect syringes and provide technical support to customers in Europe and America. Now the company has extended its COP syringe portfolio by combining its glass RTF (ready-to-fill) concept with ClearJect to create the new Gx RTF ClearJect brand. The new syringe will be manufactured at the Gerresheimer Medical Systems plant in Germany in close collaboration with the Japanese partner. The first Gx RTF ClearJect product to be manufactured is the 1-ml long syringe with staked in needle. For more information, contact Gerresheimer at +49 211 6181 246 or visit www.gerresheimer.com.
Nanoparticle Formulations
Nanoparticle Formulations
Ascendia Pharmaceuticals is a contract development and manufacturing (CDMO) company offering services for formulation development of poorly soluble drugs and other challenging development programs. Our formulation options include nanoemulsions, amorphous solid dispersions, nanoparticles, liposomes, and oral controlled release. These technologies are suitable for oral, topical, or injectable dosage forms. NanoSol is our technology for production of nanoparticle formulations. Ascendia has the capability to make nanoparticles from native drug crystals using ball milling, or lipid-based nanoparticle composites for lipophilic drugs. When the nanoparticle is delivered to the body there is greater surface area for dissolution, and by using enhancers in the formulation higher bioavailability can be more readily achieved. Ascendia can optimize nanoparticle formulations and produce clinical trial materials for first-in- man studies. For more information, contact Ascendia at (732) 640-0058 or visit www.ascendiapharma.com.
Glass & Polymer Products
Glass & Polymer Products
Every year, SCHOTT supplies the pharmaceutical industry with more than 10 billion syringes, vials, ampoules, and cartridges of glass or polymer. With regard to prefilled syringes, the company has developed a complete portfolio of both glass and polymer products. This offers pharma companies a broad range of solutions, suitable for a variety of applications like heparin, vaccines, biotech, and special applications, such as intensive care. In the field of glass syringes, the offerings range from 0.5-ml to 3-ml products marketed under the brand name syriQ®. All glass syringes are available with luer lock, luer cone, or with staked needle. SCHOTT TopPac® polymer syringes, in turn, are available in the range from 1 ml to 50 ml with cross-linked silicone for optimal functionality. For more information, contact SCHOTT at (717) 228-4200 or visit www.schott.com.
Topical Dosing Dispensers
Topical Dosing Dispensers
Topi-CLICK® by DoseLogix manufactures topical dosing dispensers revealed as the most accurate compared to other dispensers in an independent study.* Innovatively designed, Topi-CLICK® dispensers provide easy-to-use built-in applicators that eliminate transference issues with hands and assures Peace-of-MindTM dosing from start to finish. Topi-CLICK® continues to grow in popularity by setting a new standard with the distinctive “CLICK” to dispense. Products like the Topi-CLICK® PerlTM offer a revolutionary way to dispense vaginal medications and affirm that our continuous pursuit of new technologies and innovation offers the promise of a better tomorrow. *For more information and a copy of the independent study, visit www.doselogix.com/accuracy_study/, call (877) 870-8448 or email info@DoseLogix.com.
Design, Development & Manufacturing
Design, Development & Manufacturing
Phillips-Medisize is a global-leader in outsource design, development, and manufacturing services to the drug delivery, pharmaceutical, and medical device and diagnostics markets. We create satisfied customers by providing state-of-the-art technologies, innovative design, connected health solutions, and highly creative people with the skills to execute at a very high level on sophisticated projects. By partnering with our customers, early on, for device strategy and design through to manufacturing and supply chain, we assist with accelerating speed to market. We work with our customers to deploy advanced automated assembly and quality control technologies to reduce manufacturing cost while improving quality. It is our foundation and core principles – quality, innovation and investment – that have led us to our current industry position. For more information, visit Phillips-Medisize at www.phillipsmedisize.com.
Fast Track to Clinical Trials
Fast Track to Clinical Trials
With more than 140 successful FTIM fast track to clinical trial studies and materials completed, Metrics Contract Services understands what it takes to deliver this challenging and critical service. We offer a commitment to a 16- to 24-week timeline from receipt of a well-characterized NCE to shipment of clinical materials, plus specialized equipment, like our Xcelodose 600 micro dosing system, and a standardized internal process to ensure both speed and accuracy. For more information on our Fast Track to Clinical Trials services, visit www.MetricsContractServices.com.
Excipients & Technologies
Excipients & Technologies
Ashland is a manufacturer and marketer of pharmaceutical-grade excipients supported by global cGMP manufacturing and R&D with expertise in polymer science, formulation development, solid dispersions, and bioavailability enhancement. Our global manufacturing sites are held to strict cGMP standards ensuring consistent production of high-quality products. Ashland meets formulators’ needs by providing an unparalleled range of excipients and technologies, as well as long-standing polymer expertise and technical support from benchtop to commercialization for oral solids, liquids, topical, and parenteral dosage forms. Research taking place at Ashland is the foundation of technical solutions that will address drug delivery challenges in the future. For more information, contact Ashland at or visit www.ashland.com/pharmaceutical.
Contract Testing Laboratory
Contract Testing Laboratory
Impact Analytical is a contract testing laboratory supporting all phases of medical device and drug product development and manufacturing. We offer method development, validation, stability, extractables/leachables, material characterization (physical and chemical), problem-solving, unknown identification, compendial (USP, EU, JP), and release testing services. We specialize in small molecule and polymer characterization and have over 50 years of experience providing research and development support. We utilize state-of-the-art equipment, including UPLC, exact mass Q-TOF LC-MS, and ICP-MS to deliver accurate and precise data. We are cGMP registered, GLP compliant (FDA, EPA), ISO 9001 certified, and DEA licensed. The FDA recently audited Impact in late 2016 without a single 483. For more information, contact Impact Analytical at (855) 427-6583 or visit www.impactanalytical.com.
Contract Laboratory Services
Contract Laboratory Services
BioScreen Testing Services, Inc. (est. 1985, FDA registered, ISO 9001:2008 certified), headquartered in Los Angeles, CA, offers a wide range of testing services in Analytical Chemistry, Microbiology, and Human Clinical Trials . Additionally, the company offers an array of in vitro toxicological tests and consulting services. BioScreen’s two Clinical sites (located in Phoenix, AZ, and Los Angeles) have one of the largest and most ethnically diverse subject databases in the industry (including Asian subjects). BioScreen’s full-service chemistry lab is also the industry leader in heavy metal testing, boasting multiple ICP-OES, and ICP-MS instruments. Our customer service staff is friendly, helpful, and ready to assist you, and we provide routine quotes within 24 hours. For more information, visit BioScreen Testing at www.bioscreen.com.
Protect Your Brand™
Protect Your Brand™
Protect Your Brand™ is a unique offering designed to support pharma-biotech companies pursuing a dual sourcing strategy. Under this program, Alcami will support tech transfer and validation of products in advance of potential manufacturing needs without any long-term commitment or minimum annual volume. It's that simple. Protect Your Brand offers three distinct dual supply solutions to prevent disruptions from occurring at the earliest during clinical supply through to post-approval commercial production. This service can be used for drug substance, drug product, and for clinical supplies, launch quantities, and commercial supply. Protect Your Brand allows you to determine the ideal State of Alcami Readiness™ needed for your product. Responding quickly allows Alcami to minimize the effects of a supply disruption, helping prevent shortages and delays. Alcami can be ready quickly to bridge unexpected gaps in your critical supply needs. For more information, visit Alcami at www.alcaminow.com.
Autoinjector, Prefilled Syringe & Respiratory Device Training Platforms
Autoinjector, Prefilled Syringe & Respiratory Device Training Platforms
Noble, the leader in patient onboarding and drug delivery device training, develops device-comparable injection and respiratory training platforms to provide biopharmaceutical companies improvements in patient medication adherence. These training platforms are built to brand specifications and are available as off-the-shelf and customized solutions, including proprietary technologies. Noble’s offerings range from mechanical training devices to smart error-correcting training platforms, which replicate a brand’s shape, design and tactile feedback, operational forces and steps needed to administer the drug. These devices have been designed to mimic actual drug delivery devices while being a low-cost reusable solution to safely and effectively onboard users. The benefits of patients using a device-comparable trainer before using an actual drug delivery device includes users becoming familiar with a brand’s device design, functionality and ergonomics while learning correct administration technique. Companies providing reusable, device-comparable training products will be well positioned for competitive differentiation through improved patient satisfaction, adherence and outcomes. For more information, contact Noble at (888) 933-5646 or visit www.gonoble.com.
Patheon OneSource™
Patheon OneSource™
Take months off the development timelines of your large and small molecule discoveries. With Patheon OneSource™ you can combine your drug substance and drug product development and manufacturing into a single customized solution to simplify your supply chain and accelerate your discovery to proof of concept. You’ll be able to develop small molecules 8-12 weeks faster than the industry-standard 15 months, and large molecules 14-20 weeks faster. In the pharmaceuticals industry, speed is important but consistent high quality is a must. Your project will be carefully monitored by our global quality management system. This will ensure that each and every dose is equally compliant, safe and effective. It is a proven approach that prevents costly disruptions, guides continuous improvement and has earned Patheon an unmatched track record for quality. For more information, visit Patheon at www.patheon.com/onesource.
Primary Containers
Primary Containers
SiO2 Medical Products manufactures precision-molded primary drug containers molded from Cyclic Olefin Polymer (COP) and incorporates a thin, silicon-based barrier coating system on the inside surface. These primary containers combine the durability and dimensional consistency of plastic with the oxygen barrier properties, low extractables, and pH stability of a silicon-based coating. The containers have unique features not found in any containers on the market today and are ideally suited for sensitive, biopharmaceutical drugs. SiO2’s on-line inspection systems deliver containers meeting a six-sigma quality level for critical defects, and each container has a unique ID for unparalleled track and trace capabilities. SiO2 Medical Products is based in Auburn, AL, with additional offices near Philadelphia, PA. For more information, contact SiO2 Medical Products at sio2-info@sio2med.com or visit www.sio2med.com.
Specialized Products & Services
Specialized Products & Services
Pfanstiehl is a leading cGMP manufacturer of parenteral grade excipients and highly potent APIs. Pfanstiehl develops and manufactures high-purity, low-endotoxin (HPLE) carbohydrates such as trehalose, sucrose, mannitol, galactose, and mannose utilized as injectable excipients for the stabilization of proteins, mAbs, and vaccines. These HPLEs are also used as supplements for industrial cell culture, cell therapy, and cryopreservation media. Pfanstiehl also works closely with some of world’s largest multinational pharmaceutical and biopharmaceutical firms, as well as with virtual pharmaceutical companies, to synthesize proprietary and commercial compounds in quantities ranging from grams to MT quantities. Manufacturing and development occur at Pfanstiehl’s a 13-building campus located near Chicago, IL. For more information, visit us at www.pfanstiehl.com.  
Device Design, Development & Manufacturing
Device Design, Development & Manufacturing
EG-GILERO is your single-source, trusted partner for design, development, and contract manufacturing within the medical device, drug delivery, and primary pharmaceutical packaging markets. Acting as a seamless extension of your own internal resources, we accelerate speed to market of innovative devices from concept straight through commercialization. Design & Development is in our DNA. Our experienced engineering team provides a full suite of design and development services for your medical device and drug delivery device product development projects. Beginning with the end user in mind, EG-GILERO conducts clinical site user research, novel concept development, smart rapid prototyping, detailed engineering, and IP management. By adhering to strict design controls and our ISO 13485 certified quality management system (QMS), EG-GILERO integrates human factors engineering (HE75) and design for manufacturability (DFM) throughout the entire development process. For more information, contact EG-GILERO at (844) 344-5376 or visit www.eg-gilero.com.
Product Development & CMC Services
Product Development & CMC Services
Avomeen - From API Synthesis to after-market support, our experienced chemists support all segments of your drug development pipeline. As a full-service laboratory, we provide customized services that aid pharmaceutical researches, developers, and manufactures. You’ll be in good hands with our reliance on a Quality by Design (QBD) approach and rejection of the typical “list price testing.” We recognize that every project is unique, which drives us to spend the time to find out the true nature of our clients’ needs and develop a personalized plan just for you. Our multi-disciplinary scientists have years of experience with multiple dosage forms, including transdermal delivery systems, ointments, tablets, capsules, films, polymers, coatings, and drug-device combination products. Contact us today for a Complementary Initial Consultation with one of our PhD Chemists. For more information, contact Avomeen at (800) 930-5450 or scientist@avomeen.com, or visit www.avomeen.com/pharma.
Super Refined(TM) Excipients
Super Refined(TM) Excipients
Croda manufactures a complete range of high purity excipients and delivery aids, offering superior quality for the global pharmaceutical market. These excipients are ideal for multiple dosage forms, including topical, parenteral, oral, and ophthalmic formulations as well as advanced delivery systems. Croda’s Super RefinedTM excipients go through a proprietary process to remove the polar and oxidative impurities that can cause performance and stability issues. These excipients are ideal for use when working with sensitive drug actives, helping to maximize the stability and overall performance of the drug product. Excipients in the Super Refined range include PEGs, polysorbates, oils, and triglycerides, propylene glycol, castor oil, and a range of topical penetration enhancers, such as oleic acid and dimethyl isosorbide. For more information, contact Croda at (732) 417-0800 or visit www.crodahealthcare.com.
CMC Development Services
CMC Development Services
Since 1997, SL Pharma Labs has provided high-value product development, analytical, microbiological, and early phase clinical manufacturing services predominantly for parenteral, liquid, and topical products. The company’s mission is to support clients in meeting product development, analysis, regulatory approval, and commercialization timelines and budgetary requirements. With a deeply experienced and highly qualified multi-lingual staff, SL Pharma Labs works with diverse innovator and generic clients that range from large companies to virtual start-ups. Recently SL Pharma Labs has expanded its services to include development and testing of medical devices and diagnostic products under full GLP-compliance. For more information, contact SL Pharma Labs at 302) 636-0202 or visit www.slpharmalabs.com.
Advanced Delivery Devices
Advanced Delivery Devices
SHL is a privately owned developer, designer, and manufacturer of advanced drug delivery devices. We work with leading biotechnology and pharmaceutical companies to develop drug delivery systems, from compact disposable auto injectors and reusable pen injectors to complex inhaler systems. These devices are based on standard prefilled syringes (PFS) and cartridges as well as novel primary containers. SHL manufactures an extensive range of auto injectors that redefine the self-injection process by making them simple, safe, and reliable. SHL-designed auto injectors make administrating drugs easier and more consistent than manual injections, improving patient compliance and ensuring successful therapy delivery. Our concept development and innovative design takes place at our design centers in Sweden, US, and Taiwan, where experienced engineers develop product enhancements and breakthrough drug delivery solutions. For more information, visit SHL Group at www.shl-group.com.
Advanced Medical Technology
Advanced Medical Technology
Terumo Corporation, founded in 1921, is a global and innovative medical technology company of Japanese origin. Today - with almost 100 years of experience - Terumo offers you advanced technology that covers product design, development, quality management, manufacturing, logistics, customer service, and regulatory expertise. Our PLAJEX(TM) Ready-to-Fill polymer syringes have specific features that address several current issues with protein/peptide biopharmaceuticals, such as aggregation, viscous injection, and reduction of (sub-) visible particles. Among these features, PLAJEX syringes are steam sterilized and utilize proprietary i-coating(TM) technology to provide a silicone oil-free platform for applications requiring low reactive containers. For more information, visit Terumo Corporation "Innovating at the Speed of Life" at www.terumo-gps.com/US/.
On Body Delivery System
On Body Delivery System
Enable Injections’ On Body Delivery System (OBDS) delivers high-volume, often viscous drugs subcutaneously for patients to conveniently and discreetly inject at home, work, or on the move. The design is based upon over 12 years of research in minimizing injection pain with a strong emphasis on the end user and Human Factors. The platform consists of a single injector up to 5 ml, 10 ml, 20 ml, 30 ml, 40 ml, and 50 ml capacity - and associated transfer system. One of the three transfer systems (Syringe, Vial, or Fully-Automated Reconstitution) is combined with each injector to provide the user with a simple disposable package. This package transfers the drug from the original container closure to the injector in a few intuitive steps. For more information, contact Enable Injections at (513) 326-2800, jgordon@enableinjections.com or visit www.enableinjections.com.
Development/Clinical Trial Manufacturing
Development/Clinical Trial Manufacturing
Lyophilization Technology, Inc. (LTI) provides Development and Clinical Trial Material Manufacturing services to biotechnology and pharmaceutical clients spanning virtual, small, and large multi-national companies. Experience with a diverse range of products, including small molecules, cytotoxics, biologics, highly potent compounds, vaccines, medical devices, and diagnostic agents, LTI has developed formulations, manufacturing processes and prepared material for clinical trials. The operation is able to process a broad range of container closures, including 2-mL to 160-mL vials, 1-mL to 50-mL cartridges/syringes, bulk trays, and unique devices for batch sizes up to 75 L. Services consist of thermal analysis, product design, formulation development, process design/refinement, product characterization, preparation of preclinical through Phase II clinical supplies, along with technical consultation, technology transfer, validation, product/process evaluation, troubleshooting, streamlining operations, auditing, and training. For more information, contact LTI at (215) 396-8373, inquiry@lyo-t.com or visit www.lyotechnology.com.
Pharma Solutions
Pharma Solutions
BASF creates chemistry for a sustainable future offering intelligent solutions to the pharmaceutical industry. With our expertise in polymer chemistry, R&D-capabilities, and commitment to developing excipients, BASF creates solutions for Instant & Modified Release, Solubilization, Softgels, Skin Delivery, and Biologic applications. We also are a leading supplier of selected APIs, such as ibuprofen and omega-3. Our team of experienced industry specialists are here to support you in developing effective, reliable solutions to the formulation challenges you face today and tomorrow. For more information, contact BASF at (800) 469-7541 or visit www.pharma.basf.com.
Global Data & Analytics
Global Data & Analytics
PharmaCircle is a leading provider of global data and analysis on the pharmaceutical, biotechnology, and drug delivery industries. PharmaCircle’s premier database delivers an integrated scientific, regulatory, and commercial landscape view with unprecedented access to hundreds of company, product, and technology attributes. PharmaCircle connects product and pipeline information for drugs and biologics with formulation and component details, and provides due diligence level data on nearly 6,000 drug delivery technologies and devices. Drug label comparison tools and full-text document search capabilities help to further streamline research. No other industry database matches PharmaCircle’s breadth of content and multi-parameter search, filtering, and visualization capabilities. To learn more, email contact@pharmacircle.com, call (800) 439-5130, or visit www.pharmacircle.com.
Contract Manufacturing
Contract Manufacturing
By choosing AbbVie Contract Manufacturing, your team gets so much more than the typical CMO engagement. AbbVie's partners gain access to integrated scientific expertise and processes that have successfully guided many small molecule and biologic medicines through commercialization. AbbVie’s Contract Manufacturing has been serving our partners for over 35 years. Our contract/toll development and manufacturing capabilities span Fermentation, Drug Product, Potent, Hot Melt Extrusion, Prefilled Syringes, Biologics, and Bulk Active Pharmaceutical Ingredients (APIs) across 10 production facilities in North America and Europe. You can rest easy knowing we have done this before as your compound enters our cGMP contact manufacturing facilities. For more information, visit AbbVie Contract Manufacturing at www.abbviecontractmfg.com or email us directly at abbviecontractmfg@abbvie.com.
Quniton(TM) - Highly Lubricious Material Portfolio
Quniton(TM) - Highly Lubricious Material Portfolio
QunitonTM has performance capabilities uniquely designed to improve and withstand Medical and Pharmaceutical application needs. Formulated to have a low coefficient of friction, it resists bonding or sticking to a wide range of materials and diversifying interface capability. Enhancing product lifespan, QunitonTM possesses non-reactive properties that ensure consistent surface-to-surface contact over time, retaining chemical and thermal stability. Industry applications include: MEDICAL & PHARMA - Plunger and Caps, Valves, Pumps, Seals, Syringe Plugs, Vial Seals, Catheters, Connections, and Diaphragms. For more information, visit Minnesota Rubber at (952) 927-1400 or visit www.mnrubber.com.
CDMO Services
CDMO Services
Althea is a fully integrated, contract development and manufacturing organization providing clinical and commercial product development services. Althea offers cGMP drug product filling in both vials and syringes, and production of microbial-derived recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services, including upstream and downstream process development, analytical development, lyophilization cycle, complex formulation, product release and ICH-compliant stability testing. In addition, Althea offers a proprietary formulation technology platform, Crystalomics®, and an innovative recombinant protein expression technology called Corynex® technology. Althea is the manufacturing partner that delivers the relentless dedication and support our clients need. For more information, visit Althea at www.altheacmo.com.
Innovative Logisitcs Management
Innovative Logisitcs Management
AmerisourceBergen is a leading global healthcare solutions company, helping both manufacturers and providers improve patient access and enhance patient care. Our businesses have been a key component in the commercialization of virtually every successful specialty product in the past decade, including more than 100 orphan and rare disease products. We understand the unique challenges your patients face as well as the complex decisions required at each stage of the product life cycle. Our clinical trial refrigeration inventory management technology, CubixxCT® automates processes to reduce costs, errors, time, and drug accountability workloads. Product temperature is tracked in real-time, for complete visibility and transparency, 365/24/7. This portable in-home solution enhances the patient’s clinical trial experience and allows easy access to product, while sponsors, CROs, and study teams retain complete control and oversight at every location and for every product stored in CubixxCT®. For more information, visit AmerisourceBergen at www.ItTakesAmerisourceBergen.com.
Super Refined(tm) Excipients
Super Refined(tm) Excipients
Croda manufactures a complete range of high purity excipients and delivery aids, offering superior quality for the global pharmaceutical market. These excipients are ideal for multiple dosage forms, including topical, parenteral, oral, and ophthalmic formulations as well as advanced delivery systems. Croda’s Super RefinedTM excipients go through a proprietary process to remove the polar and oxidative impurities that can cause performance and stability issues. These excipients are ideal for use when working with sensitive drug actives, helping to maximize the stability and overall performance of the drug product. Excipients in the Super Refined range include PEGs, polysorbates, oils, and triglycerides, propylene glycol, castor oil, and a range of topical penetration enhancers, such as oleic acid and dimethyl isosorbide. For more information, contact Croda at (732) 417-0800 or visit www.crodahealthcare.com.
Global CRMO
Global CRMO
AMRI is a global contract research and manufacturing organization that has been working with the Life Sciences industry to improve patient outcomes and the quality of life for more than 25 years. With locations in North America, Europe, and Asia, our key business segments include Discovery and Development Services (DDS), Active Pharmaceutical Ingredients (APIs), Drug Product (DP), and Fine Chemicals. For more information about AMRI, please visit our website at www.amriglobal.com.
CMC Services
CMC Services
Ensure comprehensive product analysis with Frontage’s team of experienced analytical scientists. We specialize in analytical method development, validation and transfer for product development and clinical trial materials (CTM) manufacturing support, as well as commercial product release and stability testing. Our services are designed to help sponsors throughout the drug development process in their effort to fully characterize drug substances, developmental formulations and commercial drug products. Our facilities house a wide range of the latest analytical instrumentation for a comprehensive array of methods. And, we continually keep pace with technology to ensure compliance with evolving regulatory and market requirements. Our development team can solve your analytical challenges efficiently. For more information, contact Frontage at (610) 232-0100 or visit www.frontagelab.com.
Platform Technology
Platform Technology
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 at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled 8 FDA-approved products, including Onyx Pharmaceuticals’ Kyprolis®, Baxter International’s Nexterone®, and Merck’s NOXAFIL IV. There are more than 30 Captisol-enabled products currently in clinical development. For more information, visit Captisol at www.captisol.com.  
Oxygen Absorbers
Oxygen Absorbers
Need a solution for complex drug substance or drug product stability requirements? Multisorb Technologies’ StabilOx® oxygen absorbers are a unique product that manages moisture and oxygen inside your package to respond to ever-changing conditions within the packaged environment. By reducing oxygen concentrations while managing moisture to the required level, StabilOx works to meet your drug’s chemical and physical stability requirements. This helps ensure drug stability and performance, thereby extending product shelf-life, increasing product quality and ultimately, your revenues. Available in a variety of formats and sizes including packets, canisters, and adhesive labels, StabilOx can be used in virtually any packaging presentation. For more information, visit Multisorb Technologies at www.multisorb.com.
Solid Oral Dosage Solutions
Solid Oral Dosage Solutions
Ropack Pharma Solutions supports solid oral dosage projects from early stage formulation through clinical manufacturing, packaging, distribution, and commercial manufacturing and packaging. Recognizing the complexities of bringing a drug to market, we create efficiencies that generate valuable reductions in time and money without compromising quality and reliability. The expertise of our pharmaceutical specialists, together with gold-standard technology and proven processes, result in the highest quality outcomes, so you can outsource to RPS with confidence. RPS is an ideal partner for small and medium manufacturing lots. We provide like-for-like technology transfer for process improvement and experience in 505(b)(2) formulation. A CDMO, RPS operates facilities in Montreal, Canada, and Long Island, NY, serving the pharmaceutical and nutraceutical industries in the US, Canada, and Europe. For more information, contact Paul Dupont, VP, Business Development & Marketing, Ropack Pharma Solutions at (513) 846-0921 or visit www.ropack.com.
Medical Contract Manufacturer
Medical Contract Manufacturer
Polymer Conversions, Inc. is a Full-Service Medical Contract Manufacturer with in-house specialties in: Design – Engineering – Tooling – Validations – Clean Room Manufacturing – Assembly – Decorating - Packaging. FDA Registered – ISO 13485 – Class 7 & 8 Clean Room Operations - cGMP Compliant. Companies partner with Polymer to get advanced engineering and design assistance as well as to outsource complex, thermoplastic injection molding and value-added operations for Life Science, Medical Device, Pharmaceutical, and Biomedical products. They also offer Precision Silicone components from sister company, SILIKON Technologies, which specializes in Class 8 Clean Room Silicone Injection Molding, Assembly & Packaging. From start-up to global OEM, Polymer & SILIKON love the challenge of solving difficult issues for partners that create critical-to-life product innovations. For more information, contact Polymer Conversions at (716) 662-8550 or visit: www.polymerconversions.com.
Development Services
Development Services
UPM Pharmaceuticals is an independent, award-winning contract development and manufacturing organization (CDMO). The Bristol, TN-based CDMO serves the pharmaceutical and biotechnology industries with its offering in tablet, capsules, and semi-solid dosage form manufacturing – including DEA controlled substances (CII-CV) and a controlled humidity suite. Experienced personnel at UPM can provide high-quality pharmaceutical drug development services that include formulation development, cGMP manufacturing and packaging, analytical method development and testing from concept through commercialization all in one 476,000-sq-ft facility. UPM is characterized by its strict sense of quality, timeliness, sound scientific fundamentals, and affordability with which they complete all projects to ensure success to clinic/market. For more information, contact UPM Pharmaceuticals at (423) 989-8000 or visit www.upm-inc.com.
Room-Temperature Sterilization
Room-Temperature Sterilization
REVOX® Sterilization uses a patented, room-temperature peracetic acid (PAA) vaporized sterilant that achieves exceptionally low chemical residuals and unsurpassed materials compatibility. The REVOXTM technology eliminates inefficiencies associated with pre-conditioning and lengthy post sterilization wait times. This allows REVOX Sterilization to offer manufacturers a quick-turn, off-site sterilization service or cost- efficient on-site, in-line processing. In May 2014, a Class II implantable device was granted FDA clearance with the REVOX sterilization process. The REVOX innovation is backed by a company with over 35 years of infection prevention and control advancements structured under strict regulatory compliance standards. For more information, contact a REVOX solutions consultant at (855) 473-8690 or email at info@revoxsterilization.com. To learn more from the REVOX website, visit www.revoxsterilization.com.
Bioresorbable Polymers
Bioresorbable Polymers
RESOMER® is synonymous with parenteral controlled-release delivery systems that keep pushing the therapeutic frontier, from nanoparticles to drug-eluting films and particles. RESOMER polymers offer scientists more possibilities for targeting and timing of therapies with greater precision at lower dosages and with more efficacy and fewer side-effects. A large number of controlled-release as well as long-acting medication delivery formulations developed by and with Evonik are making a difference in millions of patient lives. In addition to supplying the bioresorbable polymers, Evonik can work with you in developing the right and extended depot formulation and manufacture of sophisticated injectable products. Evonik’s proprietary FormEZE™ delivery technology, for instance, can deliver concentrated microparticle suspensions via small needles (25-27 G) for enhanced bioavailability and greater patient comfort, including easier self-administration.: For more information contact Evonik at resomer@evonik.com.
Innovative Logisitcs Management
Innovative Logisitcs Management
AmerisourceBergen is a leading global healthcare solutions company, helping both manufacturers and providers improve patient access and enhance patient care. Our businesses have been a key component in the commercialization of virtually every successful specialty product in the past decade, including more than 100 orphan and rare disease products. We understand the unique challenges your patients face as well as the complex decisions required at each stage of the product life cycle. Our clinical trial refrigeration inventory management technology, CubixxCT® automates processes to reduce costs, errors, time, and drug accountability workloads. Product temperature is tracked in real-time, for complete visibility and transparency, 365/24/7. This portable in-home solution enhances the patient’s clinical trial experience and allows easy access to product, while sponsors, CROs, and study teams retain complete control and oversight at every location and for every product stored in CubixxCT®. For more information, visit AmerisourceBergen at www.ItTakesAmerisourceBergen.com.
Abuse-Deterrent Technology
Abuse-Deterrent Technology
The Grünenthal Group is an independent, international, research-based pharmaceutical company headquartered in Germany. Grünenthal has affiliates in 25 countries worldwide, and its products are sold in more than 155 countries. Grünenthal developed the INTAC® platform for solid oral dosage forms. The technology combines PEO-based formulations and a proprietary hot-melt extrusion process. Products based on INTAC show particular properties in regard to physical breaking strength. The technology is utilized in FDA-approved products to impede physical manipulation for misuse and abuse purposes. Grünenthal is currently developing immediate-release single-entity and fixed-dose combination opioids, modified-release prescription stimulants, and pseudoephedrine products. INTAC is a leading technology for abuse-deterrent products in the prescription and OTC space. For more information on how you can prevent abuse of your product, visit The Grünenthal Group at www.intac.grunenthal.com.
Differentiated Injectable Delivery
Differentiated Injectable Delivery
Credence MedSystems is a medical technology company focused on delivering medications safely for the benefit of our patients, caregivers and partners. The Companion Safety Syringe System was born from Credence’s core philosophy of Innovation Without Change. By providing passive safety and reuse prevention while using existing primary package components, the Companion offers best-in-class drug delivery with a vastly simplified path to market for our biotech and pharmaceutical partners. The Companion is available in luer needle, staked needle and dual chamber reconstitution configurations. In all cases, the user performs the injection, receives end-of-dose cues and then the needle automatically retracts into the syringe, which is then disabled. For more information, contact Credence MedSystems at 1-844-CMEDSYS, email info@credencemed.com, or visit www.CredenceMed.com.
Drug Delivery Solutions
Drug Delivery Solutions
Nemera is a world leader in the design, development, and manufacturing of drug delivery solutions. Its expertise covers all five modes of delivery: Ophthalmic (multidose, preservative-free eyedroppers), Nasal, Buccal, Auricular (pumps, valves and actuators for sprays), Pulmonary (pMDIs, DPIs), Dermal & Transdermal (airless & atmospheric dispensers), and Parenteral (auto-injectors, pens, safety devices & implanters). Nemera provides solutions for the pharmaceutical, biotechnology, and generics industries, from full solution development to pure contract manufacturing, through customized solutions. For more information, contact Nemera at information@nemera.net or visit www.nemera.net.
Full-Service CDMO
Full-Service CDMO
CordenPharma is your full-service CDMO partner in the Contract Development & Manufacturing of APIs, Drug Products, and associated Packaging Services organized under 5 technology platforms: Peptides, Oligonucleotides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Antibiotics. With multiple cGMP manufacturing facilities across Europe and the US, CordenPharma experts translate your complex ideas into high-value products at any stage of development. CordenPharma provides proprietary peptide, lipid, carbohydrate, and oligonucleotide technologies for cGMP-compliant products and services. We additionally specialize in the manufacturing and containment of highly potent peptide APIs (with exposure limits as low as 1 ng/m3), highly potent formulations (solid forms), cephalosporins & penicillins (oral & sterile), oncology drug products (oral & sterile), and packaging. For more information, visit CordenPharma at www.cordenpharma.com.
Liquid Formulation Dispenser
Liquid Formulation Dispenser
For years, consumers and patients have been experiencing inconvenient and annoying packaging formats for cough and cold syrups and other liquid medications. Products are difficult to use; drugs cannot be dosed easily. Aptar Pharma is introducing its patented SimpliSqueezeTM technology for pharmaceutical applications. Successfully supporting high-volume consumer brands for years, the system has shown to be widely accepted by consumers as an added value feature for liquid products. SimpliSqueeze allows for precise and hygienic administration of all kinds of liquid medications. For more information, visit Aptar Pharma at www.aptar.com/pharma.  
Coated Elastomeric Stoppers
Coated Elastomeric Stoppers
PremiumCoatTM is a novel range of elastomeric stoppers developed by Aptar Stelmi. The surface of the elastomer in contact with the drug is coated during manufacturing with a thin fluoropolymer film. This coating acts as an effective barrier to many of the extractables and leachables that can be released from the elastomer and contaminate the drug. As a result, compatibility of the drug and the closure is significantly superior with PremiumCoat stoppers. Part of the Pharma segment of AptarGroup, Inc., Aptar Stelmi is a trusted partner of leading pharmaceutical companies in the design and manufacturing of elastomeric closures for parenteral applications. AptarGroup, Inc. (NYSE: ATR) is headquartered in Crystal Lake, IL, with manufacturing facilities in North America, Europe, Asia, and Latin America. For more information, visit Aptar Stelmi at www.aptarstelmi.com.
Innovative Dosage Forms
Innovative Dosage Forms
Capsugel designs, develops, and manufactures a wide range of innovative dosage forms for the biopharmaceutical and consumer health & nutrition industries. Our unique combination of science, engineering, formulation, and capsule expertise enables our customers to optimize the bioavailability, targeted delivery, and overall performance of their products. We partner with more than 4,000 customers in over 100 countries to create novel, high-quality, and customized solutions that align with our customers’ evolving needs and benefit patients and consumers. For more information, visit www.capsugel.com.
Comprehensive Contract Testing, Development & Manufacturing
Comprehensive Contract Testing, Development & Manufacturing
Avista Pharma Solutions is a premier contract testing, development, and manufacturing organization that provides a broad range of leading services from discovery, early stage API and Drug Product development and cGMP manufacturing to stand-alone analytical and microbiology testing support. We are your experienced, capable, dependable partner, serving pharmaceutical, animal health, and medical device clients from over 200,000 square feet of laboratory and manufacturing space across three locations (Agawam, MA; Durham, NC; and Longmont, CO). We support your development program from Nomination to IND/Phase I to Proof-of-Concept/Phase II/Phase III. We have the FLEXIBILITY and CAPACITY to meet your project’s FAST TIMELINES. For more information, contact Avista Pharma Solutions at (866) 459-4600 or visit www.avistapharma.com.


















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Click here to see the showcases


INTERPHEX
March 21-23
New York, NY

PDA Annual Meeting
April 3-5
Anaheim, CA

RDD (Respiratory Drug Delivery)
April 25-28
Nice, France

Pre-filled Syringes East Coast
April 26-27
Boston, MA


AAPS National Biotechnology Meeting
May 1-3
San Diego, CA

Innovation Networking Summit & Table-top Exhibition
May 4-5
Hilton Hotel, Parsippany, NJ

CPhI North America & Informex
May 16-18
2017 Philadelphia, PA

BIO 2017
June 19 - 22
San Diego, CA

Controlled Release Society Meeting
July 16-19 Boston, MA

CPhI Worldwide
October 24-26
Frankfurt, Germany

Universe of Prefilled Syringes & Injection Devices Europe
November 7-8
Nienna, Austria

AAPS
November 12-17
San Diego, CA

 



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