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    Pharma Services Category of CARBOGEN AMCIS AG

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    Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the word.
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    01 API Development (4)

    02 Analytical Method Development (2)

    03 Analytical Testing Services (7)

    04 Antibiotic (1)

    05 Antibody Drug Conjugate (1)

    06 Chromatography (1)

    07 Clinical Supply (1)

    08 Cream / Lotion / Ointment (1)

    09 Formulation Development (4)

    10 GMP Manufacturing (1)

    11 High Potency APIs (HPAPIs) (1)

    12 Injectable / Parenteral (1)

    13 Low Temperature / Cryogenic conditions (1)

    14 Lyophilization (1)

    15 Process Development & Optimization (1)

    16 Protein / Peptide (1)

    17 Stability Studies (1)

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    01 CARBOGEN AMCIS AG (30)

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    01 Switzerland (30)

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    CARBOGEN AMCIS AG

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    CLINICAL & COMMERCIAL cGMP MANUFACTURING

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    Dishman's facilities operate to current Good Manufacturing Practices (cGMP) and can produce materials for preclinical testing, clinical trials and commercial use. Its manufacturing sites are regularly inspected by the USFDA and local regulatory bodies.

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    Pharma Service: API Manufacturing

    Category: Clinical Supply

    Sub Category: Overview
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    cGMP COMPLIANT API MANUFACTURING SERVICE PROVIDER

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    Dishman facilities operate to current Good Manufacturing Practice (cGMP) and can produce material for preclinical testing, clinical trials and commercial use. Our manufacturing sites are regularly inspected by the US Food and/or Drug Administration (FDA) and local regulatory bodies.

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    Pharma Service: API Manufacturing

    Category: GMP Manufacturing

    Sub Category: Overview
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    CARBOGEN AMCIS AG

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    CONTAINMENT FACILITIES TO PRODUCE HPAPIs

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    CARBOGEN AMCIS' containment facilities are designed based on a containment concept utilizing barrier isolation technology and Rapid Transfer Ports (RTPs) as well as a strict zone concept with pressure cascades, airlocks and access controls.

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    Pharma Service: API Manufacturing

    Category: High Potency APIs (HPAPIs)

    Sub Category: Overview
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    HPAPIs FROM PRE-CLINICAL TO COMMERCIAL SCALE

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    CARBOGEN AMCIS provides CDMO services for the development and manufacture of HPAPIs (more potent APIs). Their facilities operate to current cGMP practices and can produce material for preclinical testing, clinical trials and commercialization.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: High Potency APIs (HPAPIs)
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    BIOCONJUGATION SERVICES FOR ADCs

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    To better support customers involved in the development of new ADCs, Carbogen Amcis SAS recently completed the construction of a new clean room dedicated to the conjugation of biological molecules and small highly potent molecules at the Bubendorf site.

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    Pharma Service: API Manufacturing

    Category: Antibody Drug Conjugate

    Sub Category: Overview
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    DRUG DEVELOPMENT & COMMERCIALIZATION SERVICES

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    Carbogen Amcis SAS is a leading service provider, offering a portfolio of drug development and commercialization services to the pharmaceutical and biopharmaceutical industries at all stages of drug development.

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    Pharma Service: API Manufacturing

    Category: Process Development & Optimization

    Sub Category: Overview
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    PROCESS DEVELOPMENT & cGMP MANUFACTURE

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    Carbogen Amcis SAS is a leading service provider, offering a portfolio of drug development and commercialization services to the pharmaceutical and biopharmaceutical industries at all stages of drug development.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Process Development & Optimization
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    ROUTE FINDING THROUGH TO cGMP PRODUCTION

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    Carbogen Amcis SAS delivers leading process research services that support the drug development process. Early Active Pharmaceutical Ingredient (API) manufacture centers on the rapid synthesis of supplies necessary to perform both toxicology and early-phase clinical trials.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Route Evaluation & Development
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    FROM DEVELOPMENT SCALE TO COMMERCIAL MANUFACTURE

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    Carbogen Amcis SAS delivers leading process research services that support the drug development process. Early Active Pharmaceutical Ingredient (API) manufacture centers on the rapid synthesis of supplies necessary to perform both toxicology and early-phase clinical trials.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Scale-Up Capabilities
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    CLINICAL SUPPLY MANUFACTURING SERVICES

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    With over 10 years of experience in the manufacturing clinical supplies, Carbogen offers contract services in formulation development and for aseptic drug products for a wide range of products, including oncology and metabolic disorders therapeutics.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Overview
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    GMP PRODUCTION OF ASEPTIC PARENTERALS

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    With over 10 years of experience in the fast supply of clinical trials batches, Carbogen Amcis SAS offers comprehensive services in formulation and for aseptic drug products for a wide range of products, including oncology and metabolic disorders therapeutics.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Injectable / Parenteral
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    LYOPHILIZATION OF SMALL-MOLECULE APIs

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    Carbogen Amcis SAS located in Riom, France, focuses on the development and manufacturing of formulation dosages, aseptic filling, and lyophilization of small-molecule APIs, highly-potent APIs and biologics.

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    Pharma Service: API Manufacturing

    Category: Lyophilization

    Sub Category: Overview
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    GMP COMPLIANT PARENTERAL GRADE OF CYTOTOXIC COMPOUNDS

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    Carbogen Amcis SAS located in Riom, France, focuses on the development and manufacturing of formulation dosages, aseptic filling, and lyophilization of small-molecule APIs, highly-potent APIs and biologics.

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    Pharma Service: Drug Product Manufacturing

    Category: Injectable / Parenteral

    Sub Category: Overview
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    GMP COMPLIANT PARENTERAL GRADE OF PEPTIDE

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    Carbogen Amcis SAS located in Riom, France, focuses on the development and manufacturing of formulation dosages, aseptic filling, and lyophilization of small-molecule APIs, highly-potent APIs and biologics.

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    Pharma Service: API Manufacturing

    Category: Protein / Peptide

    Sub Category: Overview
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    NON-BETA-LACTAM ANTIBIOTICS MANUFACTURING

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    Since 2000, Carbogen Amcis SAS has manufactured over 300 GMP batches of APIs, such as highly potents, cytotoxics, proteins, mAbs, peptides, enzyme inhibitors & antibiotics (non-beta-lactams) & vaccines (non-life).

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    Pharma Service: API Manufacturing

    Category: Antibiotic

    Sub Category: Overview
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    TEMPERATURE RANGE FROM -80°C TO +250 °C

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    Large-scale production capacities (upto 4’500 L, with a temperature range from -80°C to +250 °C) allow the efficient production of early-phase APIs and large-scale intermediates under nonGMP conditions at the CARBOGEN AMCIS Swiss’ facilities.

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    Pharma Service: API Manufacturing

    Category: Low Temperature / Cryogenic conditions

    Sub Category: Overview
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    DEVELOPING STERILE & PYROGEN FREE FORMULATIONS

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    CARBOGEN AMCIS develops sterile and pyrogen-free parenteral formulations for preclinical and clinical trials. We have over 10 years of experience with injectables, liquids and semi-solid pharmaceutical forms.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Injectable / Parenteral
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    GMP COMPLIANT PRODUCTION OF SEMI SOLID FORMS

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    Since 2000, Carbogen Amcis SAS has manufactured over 300 GMP batches of APIs, such as highly potents, cytotoxics, proteins, mAbs, peptides, enzyme inhibitors and antibiotics (non-ß-lactam) and vaccines (non-life).

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    Pharma Service: Drug Product Manufacturing

    Category: Cream / Lotion / Ointment

    Sub Category: Overview
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    GMP COMPLIANT PARENTERAL LIQUID FORMULATIONS

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    Since 2000, Carbogen Amcis SAS has manufactured over 300 GMP batches of APIs, such as highly potents, cytotoxics, proteins, mAbs, peptides, enzyme inhibitors and antibiotics (non-ß-lactam) and vaccines (non-life).

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Sterile Liquid Formulation
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    ANALYSIS OF HIGHLY POTENT APIs USING NMR

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    Carbogen Amcis SAS offers customized chromatography solutions for the separation and purification of active pharmaceutical intermediates (APIs) and intermediates, including highly active APIs.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Solid State NMR
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    SEPARATION & PURIFICATION OF APIs

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    Carbogen Amcis SAS offers customized chromatography solutions for the separation and purification of active pharmaceutical intermediates (APIs) and intermediates, including highly active APIs.

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    Pharma Service: API Manufacturing

    Category: Chromatography

    Sub Category: Overview
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    ANALYSIS OF HIGHLY POTENT APIs USING UV SPECTROSCOPY

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    Carbogen Amcis SAS offers customized chromatography solutions for the separation and purification of active pharmaceutical intermediates (APIs) and intermediates, including highly active APIs.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: UV Spectrophotometry
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    IMPURITY PROFILING & IDENTIFICATION

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    Carbogen Amcis SAS state-of-the-art infrastructure includes process research and development (PR&D) laboratories, one laboratory dedicated to conjugation of small and large molecules and manufacturing capabilities.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Impurity Isolation and Identification
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    PROCESS CONTROL & MATERIAL CHARACTERIZATION

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    Carbogen Amcis SAS has established a service supporting our customers with crystallization investigations including solubility tests, salt screening, and optimization of the crystallization process and the solid-liquid separation in the API isolation process.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Trace / Elemental / Heavy Metals
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    DETERMINATION OF WATER CONTENT

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    CARBOGEN AMCIS has always strived to provide a comprehensive range of tools and techniques to facilitate this work. Analytical chemistry services support both process control and material characterization for laboratory and production chemistry from initial raw material release to the release

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Karl Fischer / Water Analysis
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    PARTICLE SIZING

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    CARBOGEN AMCIS has always strived to provide a comprehensive range of tools and techniques to facilitate this work. Analytical chemistry services support both process control and material characterization for laboratory and production chemistry from initial raw material release to the release

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Particle Size
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    GEL PERMEATION CHROMATOGRAPHY FOR IMPURITIES

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    CARBOGEN AMCIS state-of-the-art infrastructure includes process research and development (PR&D) laboratories, one laboratory dedicated to conjugation of small and large molecules and manufacturing capabilities.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Impurity Isolation and Identification
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    FORCED DEGRADATION STUDIES & STRESS TESTS

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    CARBOGEN AMCIS' forced degradation studies and stress tests encompass stress testing under acid or alkaline conditions, oxidative stress testing, and photostability studies. Based on the innovator’s specific needs, we can develop and tailor stability studies as well as forced degradation

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Batch Release and Stability Lot Testing
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    ANALYTICAL SERVICE FOR CHARACTERIZATION

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    CARBOGEN AMCIS' forced degradation studies and stress tests encompass stress testing under acid or alkaline conditions, oxidative stress testing, and photostability studies. Based on the innovator’s specific needs, we can develop and tailor stability studies as well as forced degradation

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Structure Elucidation
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    FORCED DEGRADATION STUDIES & STRESS TESTS

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    At CARBOGEN AMCIS AG, we can perform forced degradation tests, stress tests, and stability studies according to the International Conference on Harmonisation (ICH) guidelines.

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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Photostability
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