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2018 Exhibitor List

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Exhibitor List As Of September 21, 2020

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Abzena
AMRI
Cambrex
Central Glass Germany/Synquest Labs
Chiral Technologies
DavosPharma
Dottikon
Eurofins Alphora
Evonik
Fermion
Fuji Chemical Industries USA
Helsinn
Johnson Matthey
Kalexsyn
Mercachem Syncom Group
Olon SpA
Olon SpA (duplicate)
PharmaBlock
Rohner
Sanofi CEPiA
Siegfried USA
Solid Form Solutions
Solid Form Solutions (dupicate)
Solvias
Wilmington PharmaTech

Abzena, Booth Table 86

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

AMRI, Booth Table 73

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

Cambrex, Booth Table 2

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

Central Glass Germany/Synquest Labs, Booth Table 30

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-Künsebeck, 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.

Chiral Technologies, Booth Table 52

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.

DavosPharma, Booth Table 99

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.

Dottikon, Booth Table 31

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.

Eurofins Alphora, Booth Table 19 [ 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.

Evonik, Booth Table 3

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, Booth Table 1

Welcome to Fermion! We are one of the leading companies active in API’s for the innovative and generic drugs industry. Founded in 1969 as a company developing products through fermentation and being a daughter company of Orion Corporation, we offer Contract Research and Manufacturing Services to third parties worldwide. Ten innovative products, for which Fermion developed the API, have either been filed or launched/commercialized worldwide.

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, Booth table 27

Fuji Chemical Industry 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 72

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

Johnson Matthey, Booth Table 97

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.

Kalexsyn, Booth Table 66

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.

Mercachem Syncom Group, Booth Table 21

Mercachem is a privately owned leading European contract research organization offering innovative exploratory chemistry, medicinal chemistry and process R&D services to accelerate the drug discovery and development process in a flexible and cost-effective way. Mercachem was founded in 1997, occupies 3,500 m2 state-of-the-art research facilities in Nijmegen, the Netherlands, and employs more than 100 chemists. Working for many pharmaceutical and biotech companies throughout the world, Mercachem is recognized for its high-quality products and services and its unprecedented problem solving capabilities.

    Exploratory chemistry
  • Development of novel chemistry methodology
  • Single compound synthesis (reference compounds, impurities, metabolites etc.)
  • Parallel synthesis of small focused libraries

Medicinal chemistry

  • Design and synthesis of druglike molecules
  • Hit, hit-to-lead and lead optimization
  • Structure-guided lead generation

Process Research

  • Route scouting
  • Catalyst screening
  • Reaction and process optimization
  • Material supply (~ 1 kg)

Olon SpA, Booth Table 28

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

Olon SpA (duplicate), Booth Table 29

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

PharmaBlock, Booth Table 4

PharmaBlock R&D Co. Ltd. specializes in the development of innovative druglike scaffolds and building blocks. We provide world-class quality chemistry services including custom synthesis, lead generation/optimization and process development. We currently have 80 chemists including several Ph.D.s from US. Our laboratories are well equipped with the state-of-the-art instruments such as Biotage microwave synthesizers, Bruker 400 MHz NMR and Agilent 1200 LC/MS. Our goal is to help our customers accelerate their projects in lead optimization and development.

Rohner, Booth Table 18 [ company website ]

RohnerChem is a Swiss custom manufacturer specializing in organic syntheses of complex molecules. Our core technologies include transition metal catalysis, high-pressure hydrogenations, carbonylations, low-temperature reactions, hydrazine handling and polymerisations. Custom manufacturing with RohnerChem means technology transfer, process optimization, scale-up, piloting and large-scale production of your intermediate or active based on a broad tool box of capabilities and technologies. All laboratory and large scale manufacturing is carried out according to ISO up to cGMP standards.

Sanofi CEPiA, Booth Table 8

Sanofi - CEPiA Sales is a Sanofi activity dedicated to contract manufacturing services. By employing its exhaustive industrial resources and other resources expected of big pharma, CEPiA provides its clients with "fast to market" solutions. CEPiA offers API and custom synthesis expertise in both small and large molecule chemistry from lab scale through commercial quantities.

Additionally, CEPiA offers its extensive drug product capabilities including solids, semi-solids, liquids and parenteral products in vials, pre-filled syringes and devices including formulation optimization, clinical and commercial manufacturing.

Siegfried USA, Booth Table 9

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 16

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 Form Solutions (dupicate), Booth Table 17

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.

Solvias, Booth Table 5

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.

Wilmington PharmaTech, Booth Table 62

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