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    Pharma Services Category of Solara Active Pharma Sciences

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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 (2)

    03 Clinical Supply (1)

    04 Contract Manufacturing (1)

    05 Custom Synthesis & Manufacturing (1)

    06 Hydrogenation (1)

    07 Preformulation & Material Science (2)

    08 Protein / Peptide (1)

    09 Scale Up (1)

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    01 Solara Active Pharma Sciences (16)

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    Solara Active Pharma Sciences

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    ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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    Solara, Contract Research and Manufacturing Services (CRAMS) provider has a range of experience from 5 to 30 years in analytical services. They provide extensive analytical method development, qualification and validation capabilities.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Method Development and Validation
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    SALT SCREENING

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    Solara's Contract Research and Manufacturing Services (CRAMS) analytical development services include extensive salt screening capabilities & rigorous protocols, impurity marker & reference standard preparation, qualification & distribution, etc.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Salt Screening
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    POLYMORPHIC STUDIES

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    Solara's analytical development capabilities include polymorphic screening studies, identification and quantification using SSNMR, X-Ray Powder Diffraction (XRPD) and Differential Scanning Calorimetry (DSC).

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Polymorph & Crystal Screening
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    IMPURITY / REFERENCE STANDARD

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    Solara has a synthetic development team dedicated to impurity synthesis, with more than 800 compounds available. Their analytical services include impurity marker & reference standard preparation, qualification, management & distribution.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Impurity / Reference Standard
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    CUSTOM SYNTHESIS & DEVELOPMENT

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    Solara's custom synthesis and API development offers services from mg to metric ton scale. They cover the entire life cycle of a new chemical entity at all scales, from pre-clinical and clinical phases.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Custom Synthesis
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    API DEVELOPMENT SERVICES

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    Solara offers contract research, manufacturing & development services for a new chemical entity from the pre-clinical to the commercial phase. It provides services for the development and manufacture of drug substances (active pharmaceutical ingredients).

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Overview
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    SCALE-UP CAPABILITIES

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    Solara's kilo lab facility supports production from 500 g to 10-kilogram level or higher quantities of multiple batches, ideal equipment mix to support the production of smaller quantities of clinical grade material.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Scale-Up Capabilities
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    HALOGENATION CAPABILITIES

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    Solara's contract research and manufacturing services offer kilo lab facility with the ability to handle all pyrophoric reactions including fluorine chemistry.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Halogenation
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    CUSTOM SYNTHESIS AND MANUFACTURING

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    Solara, the API and CRAMS provider offers custom synthesis and API development, custom synthesis - API & molecule development, custom organic synthesis, process development in a regulatory compliant area using DOE, from mg to metric ton scale.

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    Pharma Service: API Manufacturing

    Category: Custom Synthesis & Manufacturing

    Sub Category: Custom Synthesis
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    CONTRACT MANUFACTURING FOR CLINICAL SUPPLY

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    Solara offers contract manufacturing for clinical supply - phase I, II & III clinical trials. They cover the entire life cycle of a new chemical entity at all scales, including pre-clinical and clinical phases.

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    Pharma Service: API Manufacturing

    Category: Clinical Supply

    Sub Category: Overview
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    GMP CONTRACT MANUFACTURING SERVICES

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    Solara provides customer-oriented contract research and manufacturing services (CRAMS), synthetic development services, analytical development services, GMP manufacturing, kilo-lab services, etc.

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    Pharma Service: API Manufacturing

    Category: Contract Manufacturing

    Sub Category: Overview
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    SCALE UP

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    Solara's contract research and manufacturing services support production scales from 500 g to 10-kilogram level, or higher quantities of multiple batches.

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    Pharma Service: API Manufacturing

    Category: Scale Up

    Sub Category: Overview
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    HYDROGENATION CAPABILITIES

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    Solara's contract research and manufacturing sites offer segregated hydrogenation facilities with multiple gas scrubbing systems with USFDA & EDQM compliances for hydrogenation reaction, catalytic hydrogenation, hydrogenation of organic compounds, etc.

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    Pharma Service: API Manufacturing

    Category: Hydrogenation

    Sub Category: Overview
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    IMPURITY PROFILING

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    Solara's R&D capabilities in synthetic development services, and analytical development services offers impurity profiling and quantification at trace levels (genotoxic impurities in PPB and PPM) using LCMS-MS & GCMS-MS.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Impurity Isolation and Identification
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    ORGANOMETALLIC REACTIONS

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    Solara's R&D capabilities offers synthetic organic chemistry reactions, organometallic synthesis, organometallic complexes synthesis and catalysis.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Organometallic Chemistry
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    CUSTOM PEPTIDE SYNTHESIS

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    Solara offers custom peptide synthesis & manufacturing. It is a peptide synthesis & custom peptide manufacturing company offering multi-step peptide reactions & custom peptide synthesis services for peptide APIs & peptide therapeutics.

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    Pharma Service: API Manufacturing

    Category: Protein / Peptide

    Sub Category: Synthesis
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