Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced. Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed. Global contract analytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies. Quality Compliance testing is done a wide variety of raw material and finished product forms including High Potent Active Pharmaceutical Ingredients (APIs), Raw Materials and Excipients, Powders - Capsules/Semi-solids, Oils - Oral Solutions and Syrups, Liquids, Vitamins, Minerals, and Nutritional, Natural Health Products (NHPs) – Powders, Herbals – Suspensions, Finished Pharmaceutical Products (Tablets, Capsules/Semi-solids, Oral Solutions and Syrups, Gels, Creams and Ointments, Powders, Suspensions, Transdermals etc. Bioanalytical Services for Preclinical and Clinical Studies covers Method Development, Method Validation, Lead Optimization Studies, Pharmacokinetic (PK) Analysis, Bioavailability Studies, Bioequivalence Studies, Dose Formulation Analysis, Clinical Kit Preparation, Sample Handling and Management, GCP Bioanalytical Services. Bioanalytical Technologies including Liquid Chromatography - Mass Spectrometry, Inductively Coupled Plasma – Mass Spectrometry, Capillary Electrophoresis and Nuclear Magnetic Resonance Spectroscopy and Bioanalysis of PEGylated and other Polymer-Linked Drug Assays. Large Molecule Bioanalytical Services include Immunochemistry Services, Quantitative Immunoassays, Immunogenicity Assays, Biomarkers Assays, Cell-Based Neutralization Assays, Ligand-Binding Assays. Immunochemistry services including development, validation and analysis supporting toxicokinetics (TK), pharmacokinetics (PK), immunogenicity and biomarker studies.Immunochemistry, or large molecule bioanalysis, is necessary to gain data on product efficacy, safety, disease state or mechanism of action, which will allow you to make informed and important decisions during biologic drug development. Immunochemistry Services involve Immunoassays, Biomarker Assays, Cell-Based Neutralization Assays, Immunogenicity Assays, Ligand-Binding Assays. Cell-based and ligand-binding assay services are Reporter Gene cell based assays, Enzyme-linked Immunosorbent Assay (ELISA), Mesoscale (MSD) electrochemiluminescence (ECL), Neutralizing antibody assays, Enzyme immunoassay (EIA) including acid dissociation (AD) and Radioimmunoassay(RIA) . Immunoassay Method Development &Validation are Immunogen preparation, Antibody production and labeling , Assay development/transfer and validation. Ligand binding assays (LBA) cover Enzyme Linked Immunosorbent Assay (ELISA) - including assays with Acid Dissociation (AD), Mesoscale (MSD) Electrochemiluminescence (ECL) and Radioimmunoassay (RIA).

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Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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BioReliance offers a wide range of immuno and cell based assays to support drug development throughout all stages of your product’s life cycle, from pre-clinical and clinical phases to lot release and stability testing.

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Cell based assays offer a more accurate representation of a real life model since live cells are used. They also offer the possibility of a dynamic experiment through monitoring the numbers or behavior of live cells. We can recommend strategies and provide contract services for Cell based assays.

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BioAgilytix provides the specialized large molecule insight and proven GLP / GMP knowledge needed to support a full range of cell-based assay requirements. Our veteran team possesses expertise with primary cells and transformed cell lines.

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Marin Biologic is a woman Ph.D owned and managed Contract Research Laboratory which specializes in pre-clinical and clinical development, drug discovery and validation of cell based assays and immunoassays for biotech and pharmaceutical companies in pre-IND, Phase I/II or Phase III stages.

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Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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BioReliance offers a wide range of immuno and cell based assays to support drug development throughout all stages of your product’s life cycle, from pre-clinical and clinical phases to lot release and stability testing.

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Marin Biologic is a woman Ph.D owned and managed Contract Research Laboratory which specializes in pre-clinical and clinical development, drug discovery and validation of cell based assays and immunoassays for biotech and pharmaceutical companies in pre-IND, Phase I/II or Phase III stages.

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Enzyme-linked immunosorbent assays (ELISA) are the most common method for ligand binding assays, and are a core competency for the BioAgilytix team. We use ELISA in both its original and automation-powered forms as a fast, reliable, and cost-effective platform for analyte quantification of

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Cell based assays use live cells, offering a more relevant representation of a real-life model. Cambridge Biomedical’s scientists can assist you to maximize the benefit of your cell based assay by leveraging their considerable industry experience for your benefit.

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BioReliance offers a wide range of immuno and cell based assays to support drug development throughout all stages of your product’s life cycle, from pre-clinical and clinical phases to lot release and stability testing.

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Marin Biologic is a woman Ph.D owned and managed Contract Research Laboratory which specializes in pre-clinical and clinical development, drug discovery and validation of cell based assays and immunoassays for biotech and pharmaceutical companies in pre-IND, Phase I/II or Phase III stages.

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Marin Biologic is a woman Ph.D owned and managed Contract Research Laboratory which specializes in pre-clinical and clinical development, drug discovery and validation of cell based assays and immunoassays for biotech and pharmaceutical companies in pre-IND, Phase I/II or Phase III stages.

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BioReliance offers a wide range of immuno and cell based assays to support drug development throughout all stages of your product’s life cycle, from pre-clinical and clinical phases to lot release and stability testing.

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The Cambridge Biomedical team has extensive experience across a wide range of bioanalytical immunoassays. From small to large molecule and simple to complex, our experts have seen it before. Our considerable experience will mean a swift development and simple troubleshooting.

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Cell-based neutralizing antibody assays can be difficult to develop as the selection of the most suitable assay type (indirect or direct) and format depends on thorough understanding of the drug’s mechanism of action.

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Marin Biologic is a woman Ph.D owned and managed Contract Research Laboratory which specializes in pre-clinical and clinical development, drug discovery and validation of cell based assays and immunoassays for biotech and pharmaceutical companies in pre-IND, Phase I/II or Phase III stages.

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BioReliance offers a wide range of immuno and cell based assays to support drug development throughout all stages of your product’s life cycle, from pre-clinical and clinical phases to lot release and stability testing.

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Marin Biologic is a woman Ph.D owned and managed Contract Research Laboratory which specializes in pre-clinical and clinical development, drug discovery and validation of cell based assays and immunoassays for biotech and pharmaceutical companies in pre-IND, Phase I/II or Phase III stages.

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Marin Biologic is a woman Ph.D owned and managed Contract Research Laboratory which specializes in pre-clinical and clinical development, drug discovery and validation of cell based assays and immunoassays for biotech and pharmaceutical companies in pre-IND, Phase I/II or Phase III stages.

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LabConnect's test menu includes specialized oncology assays, biomarker analysis, pharmacokinetic analysis and method development services. Scientific expertise your tests require along with the project management and client service tools.

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We are your trusted partner for the development and supply of commercial quantities of functionalized/activated polyethylene glycols (PEGs) that are essential PEGylated therapeutic proteins for drug delivery.

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As a global partner, we can supply commercial quantities of high quality functionalized PEGs, which are essential for your PEGylated therapeutic proteins.

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Shantani offers a comprehensive set of Cell-Biology and Cell-Based Assay Services. We have a fully functional cell-biology lab and over the last several years we have developed many cell-based assays for measuring biological activities of small-molecules and biologics.

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Shantani offers a comprehensive set of Cell-Biology and Cell-Based Assay Services. We have a fully functional cell-biology lab and over the last several years we have developed many cell-based assays for measuring biological activities of small-molecules and biologics.

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Shantani offers a comprehensive set of Cell-Biology and Cell-Based Assay Services. We have a fully functional cell-biology lab and over the last several years we have developed many cell-based assays for measuring biological activities of small-molecules and biologics.

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Shantani offers a comprehensive set of Cell-Biology and Cell-Based Assay Services. We have a fully functional cell-biology lab and over the last several years we have developed many cell-based assays for measuring biological activities of small-molecules and biologics.

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Shantani offers a comprehensive set of Cell-Biology and Cell-Based Assay Services. We have a fully functional cell-biology lab and over the last several years we have developed many cell-based assays for measuring biological activities of small-molecules and biologics.

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With the expertise of Upstate® and Chemicon®, Merck provides validated antibodies with breadth and depth in major research areas: Neuroscience, Epigenetics, Cell Signaling, Cancer, and Cell Structure, all backed by excellent service and support.

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We are able to serve pharmaceutical and biopharmaceutical companies of all sizes with a range of tests for drug development at both pre- clinical and clinical stages from early to late phase.

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We are able to serve pharmaceutical and biopharmaceutical companies of all sizes with a range of tests for drug development at both pre- clinical and clinical stages from early to late phase.