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    Pharma Services Category of Evotec

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    HTL Biotechnology is the world leader in the responsible development and production of pharmaceutical-grade biopolymers.
    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    01 API Development (6)

    02 Analytical Method Development (1)

    03 Analytical Testing Services (1)

    04 Chiral Synthesis (1)

    05 Controlled Substance (1)

    06 GMP Manufacturing (1)

    07 High Potency APIs (HPAPIs) (1)

    08 Low Temperature / Cryogenic conditions (1)

    09 Preformulation & Material Science (4)

    10 Small Scale Batch (1)

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    01 Evotec (18)

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    Evotec

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    SOLID STATE CHARACTERIZATION

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    State-of-the-art solid state analytical technologies and expertise including spectroscopy (FTIR, Raman, NMR), diffraction (XRPD, also non ambient and 2D), SAXS, thermal analysis (DSC, TGA, TGA-IR), microscopy (PLM, ESEM+EDX)

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Solid State Characterization
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    METHOD DEVELOPMENT AND VALIDATION

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    Evotec scientists are aided by the latest generation software tools, such as DryLab®, Empower™ and Method Validation Manager (MVM) to support both development and validation and to deliver effective solutions for each pharmaceutical development phase

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Method Development and Validation
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    SCALE-UP CAPABILITIES

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    Our scale-up capabilities include: large scale synthesis of API, intermediates (100g-200 g), route scouting for IND process, full technical package for smooth and rapid transfer to larger scales forGMP batches synthesis

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Scale-Up Capabilities
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    STRUCTURE ELUCIDATION

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    Evotec also offers in vitro metabolite profiling, structural elucidation and DDI (drug-drug interaction) studies for IND and NDA submissions during pre-clinical development and clinical stage projects.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Structure Elucidation
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    POLYMORPH & CRYSTAL SCREENING

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    Evotec's integreated CMC capabilities include: API polymorph screening, salt-selection, co-crystals screening, API route scouting, process development and scale-up, API GMP manufacturing, Solid state characterisation.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Polymorph & Crystal Screening
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    SALT SCREENING

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    Evotec's integreated CMC capabilities include: API polymorph screening, salt-selection, co-crystals screening, API route scouting, process development and scale-up, API GMP manufacturing, Solid state characterisation.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Salt Screening
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    PROCESS DEVELOPMENT & OPTIMIZATION

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    Evotec supports the key steps of the development of our partner’s API in Route scouting & identification of a new route, Custom synthesis, Analytical method development & validation, Process development to enable scale-up.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Process Development & Optimization
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    CUSTOM SYNTHESIS & DEVELOPMENT

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    Evotec supports the key steps of the development of our partner’s API in Route scouting & identification of a new route, Custom synthesis, Analytical method development & validation, Process development to enable scale-up.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Custom Synthesis
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    IMPURITY / REFERENCE STANDARD

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    Evotec supports the key steps of the development of its partner’s APIs in route scouting & identification of a new route, custom synthesis, analytical method development & validation, synthesis of reference standards & impurities, etc.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Impurity / Reference Standard
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    HYDROGENATION UP TO 40 BARS

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    From multiples sites, our development activities include Hydrogenation capacity (pressure up to 40 bars) and ability to rely on our screening experience and designated equipment supported by our specialized analytical group.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Hydrogenation
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    ROUTE SCOUTING & IDENTIFICATION OF NEW ROUTE

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    Evotec supports the key steps of the development of our partner’s API in Route scouting & identification of a new route, Custom synthesis, Analytical method development & validation, Process development to enable scale-up.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Route Evaluation & Development
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    PARTICLE SIZE DISTRIBUTION & ENGINEERING

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    Evotec's material sciences team provides support to various areas of expertise such as version selection, form control, crystallisation development, particle size distribution and engineering and solid-state landscape determination.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Particle Size Reduction & Micronization
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    GMP MANUFACTURING

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    Evotec's integreated CMC capabilities include: API polymorph screening, salt-selection, co-crystals screening, API route scouting, process development and scale-up, API GMP manufacturing, Solid state characterization.

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    Pharma Service: API Manufacturing

    Category: GMP Manufacturing

    Sub Category: Overview
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    MANUFACTURING HIGHLY POTENT COMPOUNDS

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    A notable aspect of Evotec’s API capabilities is the ability to manufacture highly potent compounds as well as manufacture and distribute controlled substances. Use, manufacture and supply of controlled substances to Schedule 1

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    Pharma Service: API Manufacturing

    Category: High Potency APIs (HPAPIs)

    Sub Category: Overview
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    MANUFACTURING CONTROLLED SUBSTANCES

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    A notable aspect of Evotec’s API capabilities is the ability to manufacture high potent compounds and to manufacture and distribute controlled substances.

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    Pharma Service: API Manufacturing

    Category: Controlled Substance

    Sub Category: Overview
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    CHIRAL SYNTHESIS

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    Evotec has expertise in chiral synthesis (asymmetric synthesis). Its capabilities include designing suitable processes that can be seamlessly scaled-up to dozens of kilos.

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    Pharma Service: API Manufacturing

    Category: Chiral Synthesis

    Sub Category: Overview
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    CRYOGENIC CAPABILITY UPTO –80°C

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    Our key aspects of Evotec’s pilot plant offering is Cryogenic capability to –80°C and  up to +160°C

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    Pharma Service: API Manufacturing

    Category: Low Temperature / Cryogenic conditions

    Sub Category: Overview
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    SMALL VOLUME API MANUFACTURING

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    Evotec has licenses to perform commercial manufacture and accordingly, dependent on the volume of material required, can provide clients with the option of ongoing commercial supply for small volume APIs.

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    Pharma Service: API Manufacturing

    Category: Small Scale Batch

    Sub Category: Overview
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