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    Pharma Services Category of Solvias

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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 (5)

    02 Analytical Method Development (1)

    03 Analytical Testing Services (1)

    04 BioAnalytical Services (4)

    05 Biologic Drugs (1)

    06 Extractables and Leachables (1)

    07 GMP Manufacturing (1)

    08 Hazardous Chemistry (1)

    09 Preformulation & Material Science (4)

    10 Process Development & Optimization (1)

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    01 Solvias (20)

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    Solvias

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    ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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    Solvias has experience in developing analytical methods throughout the entire drug lifecycle. It helps in selecting promising analytical methods and carry out development, validation and transfer within the constraints of GMP and registration deadlines.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Method Development and Validation
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    EXTRACTABLE & LEACHABLE TESTING SERVICES

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    Solvias provides expert testing and consulting services to assess the safety and integrity of extractables and leachables in pharmaceuticals by providing customizable workflow for quantitative extractables studies.

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    Pharma Service: Analytical

    Category: Extractables and Leachables

    Sub Category: Testing Services
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    CELL-BASED BIOASSAYS

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    Solvias offers various services for cell biology, cell based bioassays (potency assay), ELISA, high calibre microbiology, molecular biology and physico chemistry services through its acquired company - Confarma.

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Immunoassay & Cell Based Assay
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    BIOPHARMACEUTICAL METHOD DEVELOPMENT

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    Solvias's biopharmaceutical expertise helps in understanding the composition of your drug product. It offers method development, method validation, stability studies, characterization studies and batch release analysis for biopharmaceutical products.

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Method Development and Validation
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    BIOPHARMACEUTICAL ANALYSIS

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    Solvias's biopharmaceutical expertise helps in understanding the composition of your drug product or substance. It offers characterization studies, method development, method validation, stability studies & batch release analysis under FDA cGMP.

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Overview
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    PROTEIN STRUCTURAL CHARACTERIZATION

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    Solvias performs structural characterization for amino acid composition, misincorporation analysis and peptide mapping. It can fully characterize any protein biopharmaceuticals for the CMC section of INDs, NDAs & BLAs.

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Protein Isolation, Identification and Characterization
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    ANALYTICAL SERVICES FOR BIOPHARMACEUTICALS

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    Solvias is a world leader in contract research, development & manufacturing that offers biopharmaceutical analysis services. It can fully characterize any protein biopharmaceuticals for the CMC section of INDs, NDAs & BLAs.

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    Pharma Service: Analytical

    Category: Biologic Drugs

    Sub Category: Biopharmaceuticals
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    MICROBIOLOGICAL TESTING SERVICES

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    Solvias provides microbiological testing services for non-sterile products, sterile products, studies & environmental analysis. The main groups of microbiological analysis include microbiological identification of DNA or Maldi-TOF.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Microbiology
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    HANDLING OF HAZARDOUS CHEMICALS

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    Solvias has the experience, resources and expertise required to meet custom synthesis and manufacturing needs. It provides hazardous chemicals handling such as CO, NH3, H2, high pressure reactions, process research and development, etc.

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    Pharma Service: API Manufacturing

    Category: Hazardous Chemistry

    Sub Category: Overview
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    GMP MANUFACTURING

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    Solvias offers GMP manufacturing from preclinical support to clinical trials I, II or III and has proven manufacturing and development expertise including API synthesis up to multi kg scale under GMP as well as non GMP.

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    Pharma Service: API Manufacturing

    Category: GMP Manufacturing

    Sub Category: Overview
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    PROCESS RESEARCH AND DEVELOPMENT

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    Solvias offers manufacturing and development expertise including process research and development, API synthesis up to multi kg scale under GMP or non GMP.

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    Pharma Service: API Manufacturing

    Category: Process Development & Optimization

    Sub Category: Overview
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    POLYMORPH & CRYSTAL SCREENING

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    Solvias screens substances to identify and characterize new polymorphic forms, hydrates and solvates. Their leading edge technology provides effective crystallization screening for amorphous and hard-to-crystallize substances.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Polymorph & Crystal Screening
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    SCREENING FOR SALTS OR CO-CRYSTALS

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    Solvias proven development and manufacturing expertise includes salt, polymorphism and crystallization programs. It is a home to scientific leaders and experts in the field who can help you select the best available crystalline candidate.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Salt Screening
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    SOLUBILITY MEASUREMENT

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    Solvias offers process designing which includes temperature-dependent solubility measurements in a variety of solvents (yield or volume efficiency), identification of metastable zone width in selected solvent.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Solubility Assessment & Enhancement
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    SOLID STATE DEVELOPMENT SERVICES

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    Solvias is a world leader in contract research, development & manufacturing that offers solid state development services including screening for salts or co-crystals, polymorphism screening and crystallization screening & development, etc.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Solid State Characterization
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    API CUSTOM SYNTHESIS & MANUFACTURING

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    Solvias has all the experience, resources & expertise required to meet your custom synthesis & manufacturing needs by offering lead synthesis up to 20 kg or more, synthesis of scaffolds and building blocks & synthesis or isolation of reference compounds.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Custom Synthesis
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    CHIRAL INTERMEDIATES & APIs

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    Solvias has all the experience, resources and expertise required to meet custom synthesis and manufacturing needs. It offers process R&D for chiral intermediates, APIs or other compounds.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Fine Chemical / Intermediate
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    API SCALE-UP SERVICES

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    Solvias proven manufacturing and development expertise includes API synthesis up to multi kg scale under GMP or non GMP, process research and development, polymorphism, enantioselective catalysis, etc.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Scale-Up Capabilities
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    API DEVELOPMENT FOR CLINICAL STUDIES

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    Solvias offers development services for synthesis of APIs for preclinical and clinical studies up to phase III. It also offers chemical development & GMP manufacturing from preclinical support to clinical trial phase I, II and III.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Clinical Supply
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    DEVELOPMENT OF SYNTHETIC ROUTES

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    Solvias offers process research and development services for evaluation, scouting and development of new synthesis routes for your target molecule and development of robust and scalable crystallization procedures for intermediates and APIs.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Route Scouting
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