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    Bioanalytical method is used for quantitative determination of drugs and/or metabolites in biological matrices such as blood, serum, plasma, or urine… tissue and skin samples. The applications of such methods are pharmacology, bioavailability, bioequivalence, pharmacokinetic, and toxicology studies conducted in humans and animals. Immunogenicity tests are also considered bioanalytical methods, in that their target analytes are antiproduct antibodies in serum or plasma. Bioanalytical methods are not intended for elucidating quality parameters (e.g., identity, purity) of a biotech product; they’re intended to determine the quantity of a drug (or the presence of induced antibodies) in biological samples. For that reason, technologies used to perform bioanalytical methods vary according to the molecular entity’s nature. With chemical products, the biological components of test samples can be removed by precipitation or extraction, allowing remaining small molecule(s) to be analyzed with technologies such as LC–MS or GC–MS. With biomolecular products (or antiproduct antibodies), processing away the biological components of a sample can equally remove the target analyte, making accurate quantitation technically impossible. So for biotech products and antiproduct antibodies, bioanalytical methods require technologies that can specifically measure one biological moiety in the presence of a biological milieu. Immunological methods that use specific antigen–antibody recognition are usually chosen for bioanalytical assays applied to biopharmaceutical products because they can find the one protein of interest out of the protein mixture. Similarly, immunogenicity screening assays use ELISA-like methods to capture reactive immunoglobulins. Bioanalytical laboratory services include development, qualification and validation of biological assays such as bioassays, cell-based potency assays and binding assays. Range of bioanalytical testing services supports the characterization of biologic products from pre-clinical development through to commercialization. Physicochemical and Structural Analyses Development and testing services include: Cell Line Development, Cell Bank Manufacturing, Biosafety Testing, Cell Bank Characterization, GMP Lot Release The bioanalytical lab has significant experience working with small molecules, biologics, vaccines and biomarkers across a wide variety of technologies and therapeutic areas.

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    APC Ltd

    Anacipher

    Cebiphar

    Century Pharmaceuticals

    Crenza Pharma

    DPT Laboratories, Ltd

    Globela Pharma

    Merck Millipore

    Nanjing Dorra Pharmaceutical Technology Co.,Ltd

    Nutrasource

    PCI Pharma Services

    QUINTA-ANALYTICA s.r.o

    Siegfried AG

    Sofarimex

    Temad Co

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    Temad Co

      Virtual BoothWe think of World Class Quality.

      IRAN Iran

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      Virtual Booth Virtual Booth

      IFT Annual Expo

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      Analytical Services

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      Temad-Analytical-Services

      - Service Details

      Temad offers various analytical services such as Method of Analysis Development & Validation, Identification, Separation, Physical & Chemical characterization of impurities based on the latest pharmacopeias, Issuance of impurity profile etc.

      - Directory Listing

      Pharma Service: Analytical

      Category: Analytical Method Development

      Sub Category: Overview

      Century Pharmaceuticals

      • WHO-GMP
      • Audit Compliance

      Virtual BoothAPI Manufacturer for over 30 years & Partner of choice for multipurpose custom manufacturing projects

      INDIA India

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      Virtual Booth Virtual Booth

      IFT Annual Expo

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      Analytical Method Development

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      Century-Analytical-Method-Development

      - Service Details

      We are undertaking contracts for Analytical Method Development for APIs and Biotechnology products.

      - Directory Listing

      Pharma Service: Analytical

      Category: Analytical Method Development

      Sub Category: Overview

      QUINTA-ANALYTICA s.r.o

      • FDA
      • EDQM

      Virtual BoothGlobal provider of comprehensive top services in the field of Drug Testing, Clinical Trials & Bioanalytical Services.

      CZECH REPUBLIC Czech Republic

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      IFT Annual Expo

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      Analytical Method Development

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      - Service Details

      Methods transfers are performed according to the GMP procedures and approved method transfer protocols. Similarly, method validations are also strictly performed according to the GMP procedures and approved validation protocols.

      - Directory Listing

      Pharma Service: Analytical

      Category: Analytical Method Development

      Sub Category: Overview

      Crenza Pharma

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        INDIA India

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        Virtual Booth Virtual Booth

        IFT Annual Expo

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        Analytical Development

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        - Service Details

        Crenza is a full scale R&D centre for development of Parenteral and Ophthalmic drug products. Crenza is founded by Industry professionals with invaluable experience and proven track record of development and commercialization of Parenteral and Ophthalmic drug products for regulated markets.

        - Directory Listing

        Pharma Service: Analytical

        Category: Analytical Method Development

        Sub Category: Overview

        APC Ltd

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          IRELAND Ireland

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          IFT Annual Expo

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          Analytical Method Development

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          - Service Details

          Full method development and optimization based on client’s specific needs such as TCID50, qPCR, FACS, HCDNA/HCP determination, osmolality, pH conductivity, microscopy.

          - Directory Listing

          Pharma Service: Analytical

          Category: Analytical Method Development

          Sub Category: Overview

          Nanjing Dorra Pharmaceutical Technology Co.,Ltd

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            CHINA China

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            Virtual Booth Virtual Booth

            IFT Annual Expo

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            Analytical Method Development & Qualification

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            - Service Details

            Equipped with the advanced instruments HPLC, GC-HS, Particle size analyzer, UV, IR, Digital polarimeter, Multinuclear NMR (400MHz), we are expert in various techniques, for instance, Chiral chemistry (Classical racemate resolution, Resolution by entrainment), Second-order asymmetric transformation..

            - Directory Listing

            Pharma Service: Analytical

            Category: Analytical Method Development

            Sub Category: Overview

            Nutrasource

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              CANADA Canada

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              Virtual Booth Virtual Booth

              IFT Annual Expo

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              Analytical Method Development

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              - Service Details

              Our in-house laboratory, Diteba, offers analytical services in:Method development, validation and method transfer for Potency assay, Related substances (impurities), Dissolution methods; Forced degradation studies; and Cleaning validation testing.

              - Directory Listing

              Pharma Service: Analytical

              Category: Analytical Method Development

              Sub Category: Overview

              PCI Pharma Services

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                UNITED STATES United States

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                IFT Annual Expo

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                GMP and ICH compliant Method Development & Va...

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                - Service Details

                GMP and ICH compliant analytical equipment enabling our teams to perform simple ID testing and analytical method transfers, through method development and validation, to EU product release and ICH stability testing, ensuring data reliability and regulatory compliance.

                - Directory Listing

                Pharma Service: Analytical

                Category: Analytical Method Development

                Sub Category: Overview

                Anacipher

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                  INDIA India

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                  Virtual Booth Virtual Booth

                  IFT Annual Expo

                  Participation Not Confirmed

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                  Analytical Method Development

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                  - Service Details

                  We undertake complete analytical project development activities for formulation as well as API products. This includes analytical method development for RMs, Intermediates, Inprocess and finished product in line with regulatory requirements.

                  - Directory Listing

                  Pharma Service: Analytical

                  Category: Analytical Method Development

                  Sub Category: Overview

                  Merck Millipore

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                    UNITED STATES United States

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                    Virtual Booth Virtual Booth

                    IFT Annual Expo

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                    Development & Validation of Analytical Method...

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                    - Service Details

                    Our services include the development & validation of analytical methods. We identify by-products and determine polymorphic product forms's broad portfolio of analytical methods includes HPLC(-MS), CE, GC(-MS), FT-IR, NMR, particle size determination etc.

                    - Directory Listing

                    Pharma Service: Analytical

                    Category: Analytical Method Development

                    Sub Category: Overview

                    Sofarimex

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                      PORTUGAL Portugal

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                      IFT Annual Expo

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                      Analytical Method Development & Validation

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                      - Service Details

                      Sofarimex is the leader manufacturing company of pharmaceutical products in Portugal. This factory has a large productive flexibility, producing several pharmaceutical forms like solids, liquids, semi-solids & sterile products.

                      - Directory Listing

                      Pharma Service: Analytical

                      Category: Analytical Method Development

                      Sub Category: Overview

                      Globela Pharma

                      • WHO-GMP

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                      INDIA India

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                      Virtual Booth Virtual Booth

                      IFT Annual Expo

                      Participation Not Confirmed

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                      Analytical Method Development & Validation

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                      - Service Details

                      Globela Pharma Pvt Ltd has uplifted our existing R & D facility, and installed fully functioning in house R & D center- with state of the art infrastructure, and experienced, skilled manpower.

                      - Directory Listing

                      Pharma Service: Analytical

                      Category: Analytical Method Development

                      Sub Category: Overview

                      DPT Laboratories, Ltd

                      • FDA
                      • EDQM

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                      UNITED STATES United States

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                      Virtual Booth Virtual Booth

                      IFT Annual Expo

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                      Analytical Method Development & Validation

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                      - Service Details

                      Our comprehensive analytical method development and analytical validation services support both routine and esoteric drug development and commercial drug manufacturing projects.

                      - Directory Listing

                      Pharma Service: Analytical

                      Category: Analytical Method Development

                      Sub Category: Overview

                      Siegfried AG

                      • FDA
                      • EDQM

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                      SWITZERLAND Switzerland

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                      Virtual Booth Virtual Booth

                      IFT Annual Expo

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                      Analytical Development

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                      - Service Details

                      Modernly equipped, we provide the following range of analytical services to help bring your drug substance development project & cGMP manufacture to fruition:

                      - Directory Listing

                      Pharma Service: Analytical

                      Category: Analytical Method Development

                      Sub Category: Overview

                      Siegfried AG

                      • FDA
                      • EDQM

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                      SWITZERLAND Switzerland

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                      Virtual Booth Virtual Booth

                      IFT Annual Expo

                      Participation Not Confirmed

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                      Development of Analytical Methods

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                      - Service Details

                      Our analytical departments support the whole product lifecycle of drug substances and drug products with scientific competence and an extensive instrument pool. Optimization of existing analytical methods to improve robustness or efficiency.

                      - Directory Listing

                      Pharma Service: Analytical

                      Category: Analytical Method Development

                      Sub Category: Overview

                      Cebiphar

                      • FDA
                      • EDQM
                      • Audit Compliance

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                      FRANCE France

                      Contact Supplier Post An Enquiry

                      Virtual Booth Virtual Booth

                      IFT Annual Expo

                      Participation Not Confirmed

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                      Analytical Method Development / Overview

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                      - Service Details

                      Cebiphar had a considerable experience and knowledge in method development and validation for small molecules. Our objective is to provide our clients with the most tailored solution at each stage of their projects, and to ensure regulatory compliance.

                      - Directory Listing

                      Pharma Service: Analytical

                      Category: Analytical Method Development

                      Sub Category: Overview

                      Bioanalytical method is used for quantitative determination of drugs and/or metabolites in biological matrices such as blood, serum, plasma, or urine… tissue and skin samples. The applications of such methods are pharmacology, bioavailability, bioequivalence, pharmacokinetic, and toxicology studies conducted in humans and animals. Immunogenicity tests are also considered bioanalytical methods, in that their target analytes are antiproduct antibodies in serum or plasma. Bioanalytical methods are not intended for elucidating quality parameters (e.g., identity, purity) of a biotech product; they’re intended to determine the quantity of a drug (or the presence of induced antibodies) in biological samples. For that reason, technologies used to perform bioanalytical methods vary according to the molecular entity’s nature. With chemical products, the biological components of test samples can be removed by precipitation or extraction, allowing remaining small molecule(s) to be analyzed with technologies such as LC–MS or GC–MS. With biomolecular products (or antiproduct antibodies), processing away the biological components of a sample can equally remove the target analyte, making accurate quantitation technically impossible. So for biotech products and antiproduct antibodies, bioanalytical methods require technologies that can specifically measure one biological moiety in the presence of a biological milieu. Immunological methods that use specific antigen–antibody recognition are usually chosen for bioanalytical assays applied to biopharmaceutical products because they can find the one protein of interest out of the protein mixture. Similarly, immunogenicity screening assays use ELISA-like methods to capture reactive immunoglobulins. Bioanalytical laboratory services include development, qualification and validation of biological assays such as bioassays, cell-based potency assays and binding assays. Range of bioanalytical testing services supports the characterization of biologic products from pre-clinical development through to commercialization. Physicochemical and Structural Analyses Development and testing services include: Cell Line Development, Cell Bank Manufacturing, Biosafety Testing, Cell Bank Characterization, GMP Lot Release The bioanalytical lab has significant experience working with small molecules, biologics, vaccines and biomarkers across a wide variety of technologies and therapeutic areas.

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