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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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.

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Skyepharma's analytical experienced team supports the pharmaceutical development during every phase of the development process. Analytical validation, characterization capabilities, stability analysis, ICH Q3D and E/L capabilities.

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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.

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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..

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

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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.

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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.

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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.

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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.

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

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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.

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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.

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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.

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

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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.