Abzena, Booth Table 34

Abzena is a global integrated solution and proprietary technologies company to enable the development and manufacturing of biopharmaceutical products.

• Contract synthetic chemistry and bioconjugation research services, focused on antibody-drug conjugates (ADCs)
• Proprietary site-specific conjugation technologies and novel payloads for ADC development; and GMP manufacturer of ADC linkers, payloads & combined linker-payloads
• Immunology research studies, including immunogenicity assessment of candidate biopharmaceutical products
• Protein engineering to create humanized antibodies and deimmunised therapeutic proteins
• Cell line development for the manufacture of recombinant proteins and antibodies
• Contract process development and GMP manufacture of biopharmaceuticals, including monoclonal antibodies and recombinant proteins for preclinical and clinical studies

Adesis, Booth Table 9 [ company website ]

Adesis, Inc. is a US-only operated non cGMP chemistry CRO. We specialize in small molecule syntheses involving heterocycle chemistry, stable isotopes, reference standards, impurity syntheses, metabolite syntheses and advanced intermediates in mg to multi kg scale. Adesis has scientific depth with staffing versatility with over 55 chemists (80% Ph.D.) split 50/50 between discovery chemistry and process/scale-up chemistry. Our versatile 47,000 sq ft facility is designed to be flexible to accommodate the needs of our clients. We have 25 years of proven performance with a 99% project success rate supporting three areas: early stage research, scale up and development, and specialty manufacturing.

Advinus Therapeutics Ltd., Booth Table 59 [ company website ]

Advinus Therapeutics is a premier Contract Research Organization. Our Chemistry Services support discovery, pre-clinical and early clinical development programs. We provide services in Medicinal Chemistry, Custom Synthesis, Process Research and Development. We expertise in focused Library Synthesis to gram scale synthesis for efficacy and toxicology studies, to multi kilogram scale cGMP scale-up for early clinical development. These services are provided on both fee-for-service (FFS) and full-time equivalent (FTE) basis. Our best-in-class infrastructure, QP-audited cGMP facility and competence in discovery chemistry and process research enable us to develop cost-efficient, environment friendly, safe and robust processes that can lead to development of drug candidates for timely delivery.

Almac Sciences, Booth Table 10

Alphora Research / Eurofins Alphora, Booth Table 14 [ company website ]

Eurofins Alphora provides API technology development services for complex niche small molecules, covering pre-clinical to Phase III and commercial manufacturing. Alphora operates FDA-approved facilities totalling 51,000+ ft² including cGMP Kilo Laboratories and cGMP Plant operations, R&D and Analytical laboratories, QC/QA, as well as a separate high potency/cytotoxic facility.

AMRI, Booth Table 78 [ company website ]

AMRI, a global contract research and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. With locations in North America, Europe and Asia, AMRI's team combines scientific expertise and market-leading technology to provide a complete suite of solutions in Discovery, Development, Analytical and Solid State Services, API Manufacturing and Drug Product. The key contact is customerservice@amriglobal.com

APC Ltd, Booth Table 101 [ company website ]

APC Ltd is an award-winning and rapidly growing science and technology driven CMC development and innovation company. Our technology, capabilities, and team help our global biopharmaceutical partners accelerate the development and launch of their medicines. Our vision is to make APC the go to place for pharmaceutical and biotech R&D, and ultimately help patients gain access to their medicines in a quicker, safer, more reliable, and cost-effective manner. APC operates from a world-class pharmaceutical and biotech R&D facility in Dublin, Ireland. This state of the art facility enables APC to bring together unique technology with a world class team of scientists and engineers to pioneer innovation in the sector. APC partner with 8 of the top-10 pharma and 5 of the top-10 biotech firms in the world.

Areas of specialty include:

• Chemical and Bioprocess Design & Optimization
• Batch & Continuous Process Design
• Clinical Process Development
• Post Launch Optimization and 2nd Gen Improvements
• Regulatory Compliant NDA Data Sets
• Chemical & Bio-Process Engineering

AXYNTIS, Booth Table 89

Axyntis, French CMO with 6 GMP manufacturing sites in France, offers a broad range of chemistry and technologies, making it a reliable partner, with experienced teams.

BCN Peptides, Booth Table 16 [ company website ]

BCN Peptides is focused on the cGMP Industrial Manufacture of Bioactive Peptides for Pharmaceutical applications. We manufacture from gram until multi-kilo batches of GMP Peptide using SPPS technology. Excellent GMP compliance track record: FDA and EDQM Approved. We manufacture from the R&D, through batches for the Clinical Trials, up to Bulk Commercial Quantities. Moreover we have been authorized (since March 2010) to work as Pharmaceutical Laboratory for the Quality Control of final Drug Product.

BioVectra, Inc., Booth Table 30 [ company website ]

BioVectra offers contract development and manufacturing capacity for intermediates and active pharmaceutical ingredients (APIs) from four North American cGMP facilities. With 45 years of experience, we are a reliable and innovative partner – specializing in complex chemistries and cGMP microbial fermentation.

• Drug Development Partnerships
• Complex Chemistry
• High Potency APIs
• Microbial Fermentation
• MPEG Reagents/Conjugation
• Four North American Facilities

Buchiglas USA, Booth Table 98 [ company website ]

Buchiglas Reactor systems and Pilot Plants for cGMP manufacturing of API’s and chemicals. Glass and glass lined steel equipment based on our unique flexible ball socket connection guarantees the best performance in R&D, pilot plant, kilo lab and production. Nutsch filters, glass mixing vessels and scrubbers are available for additional process steps. Pressure reactors in Glass, Stainless, Hastelloy and other materials, for R&D purposes such as hydrogenations, using our newest Pressflow Gas Controller (bpc2) for Hydrogen as well as other gasses; polymerizations, Catalysis and Catalyst testing and a variety of other processes and projects. Booth #10

Cambrex, Booth Table 13 [ company website ]

Cambrex is an innovative life sciences company that provides pharmaceutical products, expertise and technologies that accelerate small molecule therapeutics into markets across the world.

With over 35 years of API development and manufacturing expertise, Cambrex is tried and trusted across branded and generic API markets

Cambridge Isotope Laboratories, Booth Table 64

Cambridge Isotope Laboratories, Inc. (CIL) is the world leader in the manufacture and separation of stable isotopes and stable isotope-labeled compounds. CIL offers highly pure compounds that are uniformly or selectively enriched in 13C, 15N, D, 18O or 17O, with more than 15,000 products for use as internal standards, in clinical trials, and in synthetic applications, including the manufacturing of APIs. CIL operates the world's largest 18O and 13C separation facilities and one of the only privately held D2O re-enrichment facilities to supply enough stable isotope raw material for your application. CIL's capabilities range from milligram to multi-kilogram of deuterated reagents and intermediates for any deuterated drug applications. In addition, CIL's cGMP suites can manufacture stable isotope materials to support any phase of a clinical trial or bulk APIs.

Areas of expertise:

• Stable isotope labeled internal standards
• Deuterated intermediates, deuterated solvents, and API's
• Amino acids, carbohydrates, fatty acids, steroids, metabolites, and vitamins
• Environmental standards

Carbosynth Group, Booth Table 129 [ company website ]

Carbosynth is a global supplier of over 10,000 carbohydrates & nucleosides & over 25,000 niche fine chemicals, many of which are available from stock or for bulk production. Our dedicated UK team of chemists & analysts support the catalogue to provide products on time & in specification every time.

Central Glass Germany, Booth Table 31

Central Glass Germany is dedicated to process development, upscaling and production of active ingredients and intermediates for the pharmaceutical and cosmetics industry. It operates a FDA and EU inspected facility in Halle-K�nsebeck, which it acquired from Girindus in June 2008. An experienced and highly skilled team of organic chemists and support functions, such as analytical specialists and QA/QC team, ensure success and high quality of our projects.

Chemo Dynamics, Inc., Booth Table 84 [ company website ]

New Jersey based CRO and CMO company with cGMP facility that provides broad spectrum of services including Custom Contract R&D, Custom Syntheses, Process Research/Scale-Up, Analytical Method Development and Impurity Isolation, and Small Lot Manufacturing to Pharmaceutical and Biotech companies during drug discovery, testing and clinical trial periods. Chemo Dynamics operates from a 15,000 sq. ft. facility equipped with a state-of-the-art analytical lab, seven non-GMP labs and two GMP labs. We also provide GMP services and have Schedule II-V Controlled Substance License.

Chemo Dynamics has 50 years of diversified and versatile experience in handling various aspects of chemistry and process. Well equipped to handle multistep synthesis and complex process up to 100 kg level using 100 L glass reactor and 200 L stainless reactor. Have specialized Hydrogenation capability.

Skilled and knowledgeable company that provides solutions to a wide range of custom chemical challenges for the client in the pharmaceutical, biotechnology, and flavor & fragrance industries. Our chemists are at the cutting edge of new developments in the pharmaceutical and biotechnology areas. We can be considered Creative, Innovative, Cost effective seamless extension of your internal team.

Committed to the success of our clients. Fastest concept to quantity in the industry for quick market entry.

OUR PROMISE: Quality Products • Competitive Pricing • IP Protection • Superior Service

ChemoGenics BioPharma, Booth Table 108 [ company website ]

ChemoGenics BioPharma excels in the creation and identification of candidates that progress into clinical trials through their expertise in several areas of drug discovery. Highlights of our efforts are the clinical trials of two phase 2 compounds, for which entire composition of matter was created and compounds were synthesized in our labs. Several issued patents as well as publications of two key papers in peer reviewed journals attest to our achievements. For Integrated drug discovery efforts, we have state of the art instrumentation, such as several triple quads, several HPLC's, GCMS, large scale up glassware, prep HPLC's, PDA and CAD detectors.

Chiral Quest Inc, Booth Table 26

Chiral Technologies, Booth Table 57 [ company website ]

Chiral Technologies, Inc. (CTI) is the market leader in the area of enantioselective chromatography. Together with Daicel Corporation, we support all stages of the single-enantiomer drug development process from preclinical studies to commercial drug development. We offer a full range of chiral HPLC and SFC chromatography columns for analytical, semi-preparative and preparative separations. To accelerate drug development efforts, we provide the enantioselective resolution of quantities ranging from 200 milligrams to 200 kilograms of chiral compounds, under cGMP if required. We also provide process development and pilot studies for the manufacture of chiral intermediates of approved drugs.

Cosma S.p.A., Booth Table 97

COSMA SpA (founded 1977), located in Italy, manufactures Active Pharmaceutical Ingredients for a large number of clients, mainly in regulated markets, including US, Europe and Japan. The plant includes industrial production blocks with a capacity of 140 m3 and a pilot manufacturing unit. Cosma produces both generic API and custom molecules, with a proven expertise in the development of innovative and patentable processes.

Contact us at info@cfm-group.it to set up a meeting.

CRB, Booth Table 45 [ company website ]

CRB is a global service provider of engineers, architects, constructors and consultants driven to deliver the right solutions to life science and advanced technology clients. Founded in 1984, we have grown to a team of more than 975 passionate professionals in 15 offices across the globe. CRB's single-minded focus on putting our clients' interests first – every day, on every project – defines us as a firm.

Crystallics, Booth Table 11

Crystallics and Pharmavize recently joined forces to deliver streamlined pharmaceutical development services. The combination will provide an integrated service offering consisting of solid state chemistry, analytical & formulation development, drug product manufacturing and dossier development services. The newly formed group is set to become an international, single source contractor for pharmaceutical needs that arise during pre-clinical and early phase drug development. With staff of 80 highly qualified employees and some 40 years of combined experience, the two companies serve a broad customer base from emerging biotech to tier- one pharmaceutical companies in Europe, the United States and Japan.

DavosPharma, Booth Table 121 [ company website ]

We provide custom chemistry (novel raw materials, GMP intermediates, regulatory starting materials & APIs) and custom dosage forms (parenterals and orals), with supporting development, analytics, stability and regulatory documentation. We have successfully leveraged thirty-seven years of custom manufacturing experience, forming global strategic alliances with well-vetted, cGMP custom manufacturers in the EU, North America and Asia. Our expertise enables us to match your particular need with the supplier best able to deliver your project. Davos shares your risk by billing for deliverables, not best efforts, providing an additional level of assurance and oversight between you and the supplier.

Dipharma Group, Booth Table 122 [ company website ]

Dipharma Group is highlighted on the market as one of the major European players in the field of Bulk Active Pharmaceutical Ingredients having a portfolio of about 60 APIs, with DMFs filed worldwide. We serve top ranking pharmaceutical companies in Europe, U.S.A. and Japan, supported by a fully equipped R&D Centre, consisting of more than 40 qualified researchers.

Modern laboratory equipment and one dedicated pilot plant enable us to develop and optimize complex chemical synthetic processes. Our three plants, operating in full cGMP, with a total capacity of about 550 m3, have been regularly inspected by US FDA through the years. All above competencies and capabilities make Dipharma the right partner for Custom Synthesis.

Our core technologies are Nitration, Nitroesterification, Azide Chemistry, High Pressure Hydrogenations, Chiral Synthesis, Organometallic Chemistry and Enzymatic Processes.

Domainex, Booth Table 29 [ company website ]

Domainex is a fully integrated drug discovery service company based near Cambridge, UK serving pharmaceutical, biotechnology, academic and patient foundations globally. Domainex provides highly efficient and well considered scientific solutions to enable successful drug discovery programmes against a wide range of targets. Our highly experienced molecular biologists, medicinal, computation and analytical chemists have a strong success record in drug discovery, delivering on average one candidate drug every year for the past six years.

Dottikon, Booth Table 32 [ company website ]

DOTTIKON EXCLUSIVE SYNTHESIS is specialized on hazardous chemistry, with a focus on strongly exothermic reactions as well as unstable, highly reactive, or high-potent compounds or mixtures. DOTTIKON ES manufactures high-quality intermediates and exclusive APIs, from the kilogram to the multi-ton range, for the world's leading pharmaceutical and chemical industries. Hazardous reactions often allow to shorten production and synthesic procedures, reduce waste, improve yields, selectivity, and purity, and therefore reduce overall costs. Among the core strengths of DOTTIKON ES are: hazardous reactions, such as reductions with complex hydrides, alkylations, azide chemistry, nitrations and oxidations. As well as heterogeneous and homogeneous catalytic hydrogenations, continuous reaction technologies and low temperature reactions.

Escientia Life Sciences, Booth Table 60

Based in South Windsor, CT is a global contract research, development and manufacturing organization serving Pharma and Biotech companies for the last seven years in drug discovery and development of small molecules. Escientia has a proven record of solving challenging synthetic chemistry problems by developing novel patentable routes that are safe, economical, and scalable for commercial GMP manufacturing of regulatory starting materials, advanced intermediates, and APIs. Our core strengths are in the design and development of novel commercial routes, asymmetric synthesis using organo-metallic catalysts and biocatalysts, heterogeneous and homogeneous catalytic hydrogenations, continuous reaction technologies, low temperature reactions, High Potency intermediates and APIs, and hazardous reactions.

Over the last seven years, we have successfully offered these services to more than 15 clients (65 projects) including start-up companies and large pharma/ biotech companies in the USA and Europe. We have successfully contributed in the discovery, development, regulatory support and launch of 4 new drugs (one of them became the largest selling drug) and our collaborators have filed 5 process patents.

Evonik, Booth Table 6 [ company website ]

Evonik Industries offers a full range of custom API manufacturing services as well as oral and parenteral formulation development expertise.  Our global manufacturing footprint and technical expertise provides unique flexibility and problem solving capabilities to meet your most demanding project’s requirements.

As a global leader in HPAPI manufacturing, we can seamlessly take your project from lab scale through to large commercial multi-ton quantities.  Our global development and manufacturing network provides increased flexibility to meet your demanding requirements.  At our facility in Lafayette, IN, which has been producing commercial quantities of HPAPIs for two decades, we operate with OELs <0.1 µg/m³. Evonik has experienced people with the right expertise, the right equipment and the right motivation to see your high potency projects from clinical stages through commercialization.

Our offering also includes the manufacture of non-exclusive intermediates and APIs such as L-tert-leucine based building blocks, Lisinopril, Lorazepam and Nifedipin.  We also offer amino acids, amino acid derivatives, and small chain peptides for parenteral or oral nutrition, or as building blocks for synthesis.

For your formulation needs, Evonik produces functional excipients for modified oral delivery (EUDRAGIT^®) and bioresorbable polymers for extended release parenteral formulations or medical devices (Resomer^®).  We offer formulation development services for both oral and injectable forms.  Evonik has expertise in solubility and bioavailability enhancement of oral formulations utilizing spray drying, hot melt extrusion and other proprietary technologies.  We also have expertise in injectable extended release formulations including microsphere, gel and implants.

Custom manufacturing services for oral drug products from preclinical to clinical phases as well as parenteral drug manufacturing from clinical through drug commercialization are also offered.

Fermion Oy, Booth Table 62

We offer partnering for in-licensing and co-marketing, contract manufacturing for dosage forms, contract manufacturing for small-scale APIs and being competitive in the API space by co-operating with partners for procuring early intermediates. We have two FDA-inspected plants and manufacture more than 220 tons of API per year.

Fuji Chemical Industries USA, Inc., Booth Table 51 [ company website ]

Fuji Chemical Industries USA is a wholly owned subsidiary of Fuji Chemical Industries Co. ltd. Founded in 1946. Fuji's primary mission is to provide high quality and unique specialty excipients as well as providing spray drying solutions for the pharmaceutical industry from R&D to full commercial scale.

Fuji is a recognized as a leader in spray drying technology with over 50 years of experience in open-cycle spray drying and near 20 years in closed-cycle spray drying. We can offer cGMP manufacturing, QbD support and can handle highly potent APIs.

FUJIFILM Finechemicals, Booth Table 86 [ company website ]

FUJIFILM Finechemicals is a pharmaceutical contract manufacturer with cGMP facilities for production of API, spray drying and finished dosage forms. We have particular expertise in spray drying which can be used to improve API properties and develop amorphous solid dispersions for increased drug solubility and bioavailability. We have world-class capabilities developed over decades of experience and offer customized services to support projects from early-stage development through commercial production, including custom formulation services.

Helsinn, Booth Table 77 [ company website ]

Helsinn is a leading Swiss CMO located in Biasca, Switzerland with over 30 years of experience in chemical development and cGMP manufacturing. Helsinn serves small to large biotech and pharmaceutical clients, supporting analytical and process development, manufacturing scale-up, optimization, registration and validation for mid to late stage clinical and commercial compounds. While focusing on synthetic NCEs, Helsinn performs a wide variety of services and chemical syntheses (see those called out below).

In addition to advanced intermediates and traditional small molecules, Helsinn has developed deep experience and strong competency in high containment manufacturing. Biasca possesses world class segregated facilities capable of handling highly potent, highly active, cytotoxic and other bulk drug substances that require specialized expertise, and appropriate containment equipment. Helsinn has over 15 years of experience with HPAIs (or HPAPIs) and the recent expansion of the new CYTO facility now offers fully segregated development and manufacturing for this special class of compounds. Helsinn offers comprehensive CMC services including regulatory and pharmaceutical support for all API needs. The production plants have a very successful global audit and inspection record with partners and regulatory agencies alike. Helsinn has been inspected by the FDA, Swiss Medic, PMDA, and the Korean agency. Helsinn’s most recent audit and PAI was April 2014 by the FDA with no 483 observations. Production scales range from hundreds of grams up to tens of tons for APIs in fully dedicated cGMP plants. Capabilities and Helsinn services are customized according to client needs on an exclusive basis.

Helsinn services Include, but not limited to:

• Clinical and commercial manufacturing
• CMC update and annual review
• Registration and process validation
• Batch record translation
• Route optimization
• Define all specifications & develop methods
• Supply chain management & sourcing
• Reference standards
• Ongoing stability
• Risk assessment

Integrated Analytical Laboratories, Booth Table 69 [ company website ]

Integrated Analytical Laboratories (IAL) is a NJ CRO providing practical optimization strategies to meet the analytical development requirements of all types of raw materials, APIs and drug products. Our services include full method development, validation and stability testing of in-process and finished product samples. Our consulting services include forced degradation studies to help solve the most complex analytical problems. IAL's 20 plus years of focused expertise allows accelerated scheduling to help assure successful product commercialization, a key benefit for small or virtual companies. Our insight and focused experimental design experience allows us to get the analytical development process right the first time.

We work with products in various therapeutic areas, at all stages of development, filing, approval and commercialization. We help with formulating regulatory strategies and interactions with the FDA, and are experienced in preparing validation and testing protocols, product specifications and analytical reports for CMC submission.

IAL specializes in Elemental Impurities testing by ICP/MS. We can help you qualify your materials, APIs and products in accordance with the new USP/ICH <232>, <233>, Q3D guidelines as the deadline quickly approaches. Don't risk delay! Visit us at Booth #64 or contact alanbelkin@ialonline.com to review your project.

Inventys, Booth Table 119 [ company website ]

Contract Development & Manufacturing Services

• APIs
• Registered Starting Materials
• Advanced Intermediates

Taking your Clinical Product from Concept to the Clinic

• Novel Route Synthesis with Focus on Sustainability, IP
• Quality & Safety By Process Design
• Convergent Synthesis
• Impurity Identification & Control
• Reaction Mechanisms with Crystalline Intermediates

Why Inventys

• Excellence in Engineering & Project Management
• Responsible Practices (since 1976) towards Environment, Society and Employees
• Backed by GMP Plant, cGLP Laboratory PLUS ISO-9001, ISO-14001, OHSAS ISO-18001 compliant processes gm Scale Synthesis --> Scale Up --> Kilo Plant --> Pilot --> 10 MTs
• Batch OR Continuous Processes

Johnson Matthey, Booth Table 111

Johnson Matthey Fine Chemicals combines our proven specialist expertise and 200-year heritage to deliver a collaborative service offering focused on strengthening your products to ensure they get to market more efficiently. Built around core offerings of Custom Pharma Solutions, Controlled Substances, Catalysts, API & Life Cycle Management, our industry leading technologies and expertise, coupled with our global manufacturing footprint, enable us to deliver expert solutions for all your complex chemistry needs.

Our diverse technologies and capabilities include an unmatched portfolio of catalyst technologies; chiral synthesis; highly potent APIs and controlled substances; drug-conjugates and linker technologies; solid form sciences; manufacturing-scale chromatography; large scale cryogenics and process analytical technologies. Our custom development and manufacturing services are provided through a global network of eleven facilities in Europe, North America and Asia.

Jubilant Biosys Ltd, Booth Table 54

Jubilant Biosys Limited (JBL) & Jubilant Chemsys Limited (JCL), collectively referred to as Jubilant, are sister concerns of Jubilant Life Sciences (a $900MM Sales Corporation) providing innovative drug discovery services to the global life sciences, agrochemicals and specialty chemicals industry through its multi-location research centers (India and USA). Partnering with the Global Top-10 Pharma, Jubilant's team of 600+ scientists have an track record of working on 60+ integrated programs out of which 12 successfully delivered at Lead Optimization/ IND stage, Jubilant's services in discovery research include:

• Target Identification/ Target Validation to Lead Optimization/ Preclinical candidate, for multiple therapeutic areas viz; Oncology, Metabolic Disorders, CNS, Pain, Inflammation, Fibrosis and Respiratory diseases.
• Functional services comprising of computational chemistry/ molecular modeling, medicinal chemistry, synthetic chemistry, scale-up (Non-GMP & GMP), structural biology, ADME-PK, in-vitro and in-vivo biology and IND enabling GLP toxicology.

Kalexsyn, Inc., Booth Table 71 [ company website ]

Kalexsyn's world-class scientists provide hit validation, lead optimization and solving tough synthetic problems. We also provide stable label synthesis and custom synthesis. Our process route development, process improvement and early API team is comprised of a group of senior scientists formerly with large pharma API teams. We offer clients an outstanding CRO experience with fixed quote, tailored short and long term FTE arrangements. Kalexsyn is privately owned with research laboratories in Kalamazoo, Michigan.

Kaneka Americas, Booth Table 76 [ company website ]

Utilizing enzyme-mediated synthesis and fermentation technology along with a wide variety of advanced organic synthetic methodologies, Kaneka has established itself as a leading innovator and reliable manufacturer of chiral pharmaceutical intermediates and fine chemicals.

LinkChem, Booth Table 12 [ company website ]

LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development, and manufacturing of key intermediates and API's.

MRIGlobal, Booth Table 128 [ company website ]

At MRIGlobal, our focus in Pharmaceutical Sciences is providing clients with scientifically driven results to keep projects on track. Our 80 years of success is built on a strong foundation of technical competence, communication, quality, and teamwork. Together, we achieve your objectives, continually assessing your parameters and goals.

Navin Fluorine, Booth Table 66 [ company website ]

Navin Fluorine International Limited(NFIL), is a global leader in fluorination & high pressure technology, research and manufacturing. From our locations in the UK, India and USA we have built valued relationships spanning all areas of the chemical industry, ranging from pharmaceuticals to electronics. Our manufacturing capabilities range from R&D through to commercial scale production and we also offer a continually expanding portfolio of building blocks and fine organic chemicals. Our specialism in fluorination technology together with expertise in general organic synthesis at all scales (cGMP and non-cGMP) allows us to bring an extensive range of fine chemicals to you through our portfolio, as well as servicing a wide, chemically diverse range of custom synthesis, development and scale-up projects. For more information please contact: Ajay K. Ohri, Global Head of Business Development at 908 300-2196 or ajay.ohri@nfil.in

Neopharm Labs, Booth Table 109 [ company website ]

Neopharm Labs is a full service analytical testing laboratory. We offer a full suite of analytical solutions to provide a range of services at every stage of the drug development cycle. Complete portfolio of R&D, GMP validation and testing for the Life Science industry: Chemistry including extractable & leachable, Microbiology including sterility, ICH stability studies, Quality Assurance and Regulatory Affairs consulting services. With facilities in the Montreal, QC and Boston, MA regions, our personalised approach will take you beyond services to solutions.

• Chemistry
• Microbiology
• Stability
• Method Development & Validation
• Analytical Tech Transfer
• DS & DP Impurities
• Regulatory & Compliance Support

NuChem Therapeutics, Booth Table 133 [ company website ]

NuChem Therapeutics is a high end Medicinal Chemistry contract research organization located in Montreal, Quebec, Canada built by ex-Merck Frosst, AstraZeneca and Vertex scientists. NuChem offers a variety of services to support the biotech and pharmaceuticals industries to help identify and optimize pre-clinical candidates in the area of small molecule drug discovery.

Olon S.p.A., Booth Table 20 [ company website ]

OLON SpA, Italian APIs manufacturer founded in 1907, acquired Infa Group in May 2016. Thanks to this merger Olon relies now on 8 European manufacturing facilities, self-identified under GDUFA and FDA-inspected, and offers its longstanding experience and know- how for superior Contract Manufacturing and Development Services to Pharma companies worldwide.

OmniChem, Booth Table 87 [ company website ]

OmniChem offers high-technology know-how, quality, flexibility and trustworthiness, based upon personnel of the highest quality, on adapted equipment and multi-purpose facilities. Each project is carried out in close and frank co-operation with the customer’s technical staff and coordinated through an efficient project management system.

Pacific Bridge Medical, Booth Table 52

Pacific Bridge Medical (PBM) was founded in 1988 to help international medical companies solve their most complex problems while doing business in Asia. Since then, PBM has assisted hundreds of healthcare companies with business development and regulatory issues in Asia. We provide our services to all types of medical firms, including medical device, IVD, pharmaceutical, API, biotechnology, OTC, consumer healthcare, cosmetic, and veterinary companies.

In addition to our expert staff in the D.C. area, we have our own offices in China, Japan, Singapore, and Hong Kong. We also work with strategic affiliates throughout Asia.

Japanese API Market http://www.pacificbridgemedical.com/regulatory-services/pharmaceutical/product-registration/japan/

Patheon, Booth Table 1 [ company website ]

Patheon is a leading global provider of pharmaceutical development and manufacturing services. With approximately 9,000 employees worldwide, Patheon provides a comprehensive, integrated and highly customizable set of solutions to help customers of all sizes satisfy complex development and manufacturing needs at any stage of the pharmaceutical development cycle.

Pfanstiehl, Inc., Booth Table 65 [ company website ]

Pfanstiehl is a US-based, SafeBridge Certified, cGMP CDMO for High Potency, Cytotoxic APIs, and High Purity Low Endotoxin Injectable Grade Formulation Ingredients. With over 50 years of experience in custom synthesis and process development, Pfanstiehl is a uniquely qualified partner to help solve your complex chemistry challenges

Pharmaceutical Outsourcing, Booth Table 117 [ company website ]

Start receiving your free copy today. Pharmaceutical Outsourcing is the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry.

Pharmavize-Crystallics, Booth Table 11

Crystallics and Pharmavize recently joined forces to deliver streamlined pharmaceutical development services. The combination will provide an integrated service offering consisting of solid state chemistry, analytical & formulation development, drug product manufacturing and dossier development services. The newly formed group is set to become an international, single source contractor for pharmaceutical needs that arise during pre-clinical and early phase drug development. With staff of 80 highly qualified employees and some 40 years of combined experience, the two companies serve a broad customer base from emerging biotech to tier- one pharmaceutical companies in Europe, the United States and Japan.

Piramal Pharma Solutions, Booth Table 39 [ company website ]

Piramal Pharma Solutions is a Contract Development and Manufacturing Organization (CDMO), offering end-to-end services required to bring a drug to the market place faster. We offer Pharmaceutical Development and Manufacturing solutions through collaborative partnership models and we work with our customers throughout the drug life cycle.

We have created a vast network of Development and Manufacturing facilities located in North America, Europe and Asia that offers a multitude of services covering the entire drug life cycle, from Drug Discovery & Development to Commercial Manufacturing of off-patent Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs). Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

PROCOS S.p.A., Booth Table 110 [ company website ]

Procos S.p.A., established in 1945, is a wholly owned subsidiary of the Japanese company, CBC Co. Ltd Group, specializing in the development, scale-up and production of Active Pharmaceutical Ingredients (API’s), advanced intermediates and related services for the pharmaceutical industry. Our core business sectors include custom synthesis and generic API manufacturing. The 110,000 sq. meter, cutting-edge multipurpose plant is located in Cameri, Italy, fully designed under cGMP compliance, has been successfully audited and approved by AIFA, FDA and PMDA. We successfully completed a capacity expansion in 2015, and in 2018, Procos will be ready with manufacturing capabilities for HPAPI at OEL-4 and OEL-6, focused in oncology.

Recipharm AB, Booth Table 2 [ company website ]

Recipharm is a leading contract development and manufacturing organisation (CDMO) headquartered in Stockholm, Sweden. We operate 20+ development and manufacturing facilities in Europe, the US and India. For over 20 years we have been there for our clients providing pharmaceutical expertise and a full service offering.

Ricerca Biosciences, Booth Table 19 [ company website ]

Ricerca provides complete analytical chemistry, synthetic chemistry, engineering and API manufacturing services designed to meet your needs from lead identification to commercial launch. Our experienced chemistry team has a proven track record for excellence in the development, scale-up and manufacturing of small molecule APIs to any regulatory requirement. Our facilities in Concord, Ohio, contain state of the art analytical instrumentation, kilo labs and pilot plant reactors, which allow flexible manufacturing capacities ranging from 22 to 3,000 liters. All services are provided to meet the highest quality standards utilizing cost-effective strategies.

Rohner, Inc., Booth Table 18

SafeBridge, Inc., Booth Table 82 [ company website ]

SafeBridge Consultants, Inc. ("SafeBridge") is the premier resource for high-level safety, health and environmental support to the pharmaceutical and biotechnology industry. Comprised of industry leaders in toxicology, analytical chemistry and industrial hygiene. SafeBridge has developed the “brand name” in the pharmaceutical industry as a leader in the field of advanced worker protection programs for potent drug handling and risk assessment for product protection.

Sai Life Sciences, Booth Table 127

Established in 1999, SAI Life Sciences continues to build expert core capabilities to handle today’s highly complex intermediates and APIs. Our pharmaceutical/biotech clients gain a competitive advantage through reduced timelines and risk minimization by utilizing one or more of SAI’s integrated scientific platforms: MedChem, Biological Services, Analytical Development, Formulation Development, PRD and commercial manufacturing. In providing custom research and manufacturing services to the life sciences community, we pride ourselves on creating solutions that add value. When we build a partnership with clients, we amplify our mutual interests and successes. At SAI, we refer to +1 for the additional value we aim to bring to each project – by delivering solutions that add up.

Sanofi US CEPiA, Booth Table 8

ScinoPharm Taiwan, Booth Table 95 [ company website ]

ScinoPharm Taiwan Ltd. is a leading process R&D and API manufacturing service provider to the global pharmaceutical industry. With cGMP production facilities, ScinoPharm offers services to small molecular and peptide APIs custom synthesis for clinical study and commercial use. Combining cost-effective resources and productivity of Asia along with unmatched regulatory know-how, ScinoPharm is uniquely positioned to serve global pharmaceutical R&D and manufacturing needs at any level and for any company in this sector.

Selvita, Booth Table 47 [ company website ]

Selvita is an integrated drug discovery service provider. We offer support at every stage of the early drug discovery, starting from the target identification up to the selection of a clinical candidate. In addition to the contract chemistry services such as medicinal chemistry, in silico modeling, custom organic synthesis, scale-up and process chemistry, we offer biology and analytical services, as well as pharmacological and efficacy testing with in vivo models of disease available for variety of indications.

Servier CDMO, Booth Table 61

Servier is a global pharma company that has commercialized more than 50 molecules over the last 60 years. We are selling our products in 140+ countries and we invest, each year, 25% of the turnover in innovation and R&D. The business unit “Servier CDMO” was created to bring this expertise to the companies looking for quality, reliability and exibility in their projects. We can cover all the phases from the clinical supply to the manufacturing for drug substance and drug product. The network of 11 facilities across the world with a reliable supply chain can deliver to the partner the benefit of our experience and resources.

SGS North America, Booth Table 96 [ company website ]

SGS Life Sciences is the premier global CRO providing clinical research, analytical development, biologics characterization, biosafety, and quality control testing. Operating 21 facilities in 11 countries, SGS represents the broadest, wholly-owned, global network of contract analytical laboratories. We deliver complete lifecycle solutions for pharmaceutical, biologics, and medical device manufacturers. SGS provides GMP/GLP contract laboratory services that include analytical chemistry, microbiology, stability, bioanalysis, extractables/leachables, virology, cell bank and virus seeds characterization, and protein analysis.

SGS also offers GMP/GLP contract laboratory services that include: analytical method development and validation, cell-line characterization, antibody product analysis, glycosylation analysis, host-cell impurity testing, protein/peptide analysis and quantification, biologics safety testing, as well as bioanalysis, mass spectrometry and immunoassays.

Shiono Finesse, Booth Table 55 [ company website ]

Shiono Finesse offers contract manufacturing services of API and related services including custom synthesis, process development, and analytical services. Our manufacturing facility is GMP-compliant and has been regularly inspected by FDA as well as other health authorities. We have a capacity for full range manufacturing, from gram-scale of investigational drug development to metric tons of commercial products. High quality services we render are supported by advanced technology and fully implemented quality assurance system. We have long experience in contract manufacturing with many customers.

Siegfried USA, Booth Table 3 [ company website ]

Siegfried is a globally active, independent Swiss company. As a supplier and service provider for the worldwide pharmaceutical industry, we concentrate on the development and production of pharmaceutical drug substances and customer-manufactured finished drugs, and offer all related services. We focus on maintaining the highest level of competence, working together with our clients as partners. Our specific know-how in process development, chemical and pharmaceutical production, and managing complex outsourcing projects is used to contribute significantly to the success of our customers.

Solid Form Solutions, Booth Table 15 [ company website ]

Solid Form Solutions is a world leading contract research organization (CRO) providing the pharmaceutical industry with polymorph, salt and co-crystallisation screening services. Our services also include crystallisation development, particle development as well as basic physical properties / developability characterisation. Our aim is to be flexible, understand our client’s solid form problems and recommend workable solutions. Whether our expertise is required to deliver a solid form screening program or tackle specific problems encountered during drug manufacture, Solid Form Solutions will provide an unrivalled service.

Solid State Pharma Inc, Booth Table 56 [ company website ]

Solid State Pharma Inc. is a leader in the delivery of crystallization engineering services including screening and selection of polymorphs, co-crystals, salts, and crystallization process development and optimization. Solid State Pharma workflows have been developed by combining fundamentals of crystallization and solid state science with years of experience and high throughput techniques. Please contact Mahmoud Mirmehrabi, PhD, at Mahmoud@solidstatepharma.com to set up a meeting at the show.

Solvias, Booth Table 5 [ company website ]

Solvias is a privately held company located in Basel/Switzerland. With over 300 highly qualified employees, Solvias supports the research and development of new drug substances and the optimization of manufacturing processes for pharmaceutical, biotechnology and life science companies worldwide. Customers benefit from a wide range of experience in the following areas: Chemical Development and cGMP Manufacturing , Catalysis, Analytical Services, Process analytical technologies and, Polymorphism, salts and crystallization. All analytical services are cGMP-approved by the FDA and Swiss authorities.

ST PHARM, Booth Table 58 [ company website ]

ST Pharm, located in South Korea, is a customer-focused CMO that provides high quality products and services to clients for their successful drug development and commercialization. We offer small molecule APIs and oligonucleotide APIs by and with cGMP compliance, production capacity and technical capability, open communication and competitiveness thereof.

Sundia MediTech Company, Booth Table 7 [ company website ]

Founded in 2004, Sundia MediTech Company Ltd. is a leading China-based CRO providing a broad range of high-quality, cost effective drug discovery and development services. Sundia provides services to over 160 customers globally, including a vast majority of the top 20 pharmaceutical and biotechnology companies, as well as fast-growing biotechnology and specialty pharmaceutical companies and renowned academic and research institutions. The Company conducts its laboratory and development activities in three primary facilities in China: a) Shanghai Zhangjiang Hi-Tech Park; b) Shijiazhuang; and c) Taicang.

Syncom, Booth Table 21 [ company website ]

Syncom is a privately owned company established in 1988. It has grown rapidly in recent years and currently employs 130 chemists 75 of whom have PhD degrees and the rest a masters degree or equivalent. About 95% of the work carried out is for the pharmaceutical industry and the other 5% is devoted to the synthesis of organic materials. The company is involved in Medicinal chemistry and drug discovery and synthetic support for chemical development and process research. The major focus is on synthesis for discovery chemistry support. Syncom is located in the Groningen in The Netherlands. Our business is with big farma companies, medium sized and biotech companies form Europe and the US.

Synquest Labs, Booth Table 31 [ company website ]

SynQuest specializes in fluorinated organic and inorganic chemicals, providing a creative and innovative range of building blocks, reagents and compressed and liquefied gases. Synquest is able to assist with your fluorinated and non-fluorinated procurement needs at any scale. Small scale laboratory research and pilot scale at Synquest can be transitioned as the project develops and scales up to custom manufacturing and full commercialization at Central Glass Germany and Japan.

TCI America, Booth Table 80 [ company website ]

TCI is a leading global manufacturer and supplier of specialty chemicals to the pharmaceutical, electronic, cosmetic, chemical, environmental, and biotech industries. Drawing on over 80 years of synthetic organic chemistry experience, TCI develops new technology that produces rare and novel compounds. Our current catalog lists over 25,000 organic and biochemical products for use in research and production with over 8,000 unique to TCI. Our manufacturing capabilities include multi-step synthesis and continuous production from milligram to ton-scale for custom and contract research services.

Tepnel Pharma Services, Booth Table 27 [ company website ]

Tepnel Pharma Services is an independent Quality Control Laboratory based in Scotland. With over 40 years plus of supporting stability testing on Tablets, Capsules, Parenteral and Lyophilised Products we provide out-tasking management for biopharmaceutical companies supporting global registration stability programmes. Our lean approach to stability protocol management of multi APIs and drug product programmes facilitates significant economic value as high as 50% cost savings for some programmes compared with standard initiation procedures. As a leading member of our local Life Science Community, advocating Scotland’s shared attitudes and responsibilities, Tepnel has a clear collective identity and set of values; People, Progressive and Principled, ensuring that, Together we are Better.

WeylChem International GmbH, Booth Table 23

WeylChem is your partner of choice when it comes to novel intermediates, developed under the strictest confidentiality in close cooperation with our customers. We offer custom manufacturing solutions with a broad selection of chemical technologies, from early pilot scale of tens of kg to full industrial scale in the tens of tons range. Our broad range of advanced intermediates and reagents, manufactured under the strictest quality requirements, are used as building blocks and starting materials for innovative pharmaceutical products.

Customer proximity is important. We deliver from our facilities, located in Europe and in the US.

Contact us today: services@weylchem.com

Wilmington PharmaTech, Booth Table 67 [ company website ]

Wilmington PharmaTech Company (WPT) is a leading global service company specializing in research and development of process chemistry and medicinal chemistry for the pharmaceutical and biotechnology industries. Founded in 2003 in Newark DE, WPT has a proven track record of providing fast, reliable and quality services for pharma and biotech companies worldwide. In addition to the five cGMP kilo labs we have in Newark DE, we recently acquired a pilot plant location which will enable us to further expand our US capabilities. Our research site in China along with several joint ventures allows for scale up of bulk intermediates and production of raw materials. Today, WPT is known as one of the best, fastest and most reliable API suppliers in the United States. Based on established expertise and proprietary technologies, WPT has developed a wide range of capabilities for research and development of today’s medicines. Our capabilities include:

• cGMP Synthesis
• Stable Isotope Labeling
• Bulk Intermediate Production
• FTE/Time-Based Process and Analytical Research
• Salt and Polymorph Screening
• Genotoxic Impurities (GTI’s) and Trace Analysis
• Analytical GLP/GMP Full Services
• ICH Stability Studies and Sample Storage
• Impurity Identification, Preparation and Qualification: Process impurities, Stability impurities, and Metabolites
• R&D areas: Chiral separation, Continuous Flow Reactions, Nucleotides, Oligonucleotides
• Current expansions: US Based Pilot Production Plant, HPAPI Suites and Bioanalysis

Yamasa Corporation, Booth Table 25 [ company website ]

Yamasa has expanded its business specialized in nucleic acid related compounds which are now used in broad fields such as APIs, pharmaceutical intermediates, food additives, cosmetic ingredients and other industrial products. An enzyme called Nuclease P1 was discovered by our own research which selectively degrades RNA into 5'-nucleotides. In 1957 we invented an efficient separation technology of 5'-nucleotides and established an industrial manufacturing process of nucleic acid-based umami seasoning, inosine 5'-monophosphate and guanosine 5'-monophosphate. Along with our abundant experience and technology accumulated for many years, Yamasa provides products and services which realize your various needs.