Analytical Development Services

Analytical Development: Analytical methods are developed to understand the physicochemical and biophysical characteristics of a product. This characterization includes but is not limited to:

Product characterization: This provides a comprehensive understanding of the properties of the molecule, and also provides the quality program in selecting the appropriate test methods to be used for product release and stability monitoring.
In-process, bulk and drug product release testing: These are tests completed during and at the end of manufacturing of bulk or API (active pharmaceutical ingredient) or drug product (formulated bulk or API) using pre-approved methods and specifications to assure identity, purity, strength, potency, quality, safety, and lot-to-lot consistency.
Stability indicating assays: These are methods to detect changes during storage of the product to ensure quality through the intended shelf life.
Impurity profile: These are analytical techniques to detect and quantify impurities for both small molecule compounds and large proteins. For proteins we are concerned with microheterogeneity and posttranslational modifications; i.e., aggregation, deamidation, denaturation, disulphide bond scrambling, oxidation of methionine and cysteine, and truncation.

The analytical services we provide are:

Chromatographic Separations: HPLC � based on different combinations of separation and detection strategies.
Electrophoretic Separations: Both SDS-PAGE and isoelectric focusing.
Peptide Mapping: This technique involves chemical or enzymatic cleavage of peptide bonds in a protein resulting in the formation of peptides with subsequent analysis by HPLC.
Amino Acid Composition: This is a method to quantitate amino acids in a protein or a peptide for identity and quantity, also by HPLC.
Concentration Determination: These are quantitative methods to determine product concentration.
Residual Analysis (Examples: IPTG, Kenamycin, TritonX-100): Analytical techniques to quantitate process impurities. Methods development for cleaning validation.
Immunochemistry: Immuno-assays are specific for detecting and quantifying biochemical molecules using antibody-antigen chemical detection system. These will rely on Western Blot and ELISA techniques:
Western Blot: Western Blotting allows for the resolution of proteins by molecular weight.
ELISA (enzyme-linked immunosorbent assay): This assay determines antibody titer. The immunizing antigen is bound to the surface of a polystyrene well, blocked to reduce non-specific binding, incubated with various dilutions of the test serum and allowed to react with enzyme-linked secondary antibody to the appropriate species being tested. The final stage shows color development due to reaction between the enzyme conjugate and the appropriate substrate.
Sugar Analysis of Glycoproteins: These are analytical methods to characterize carbohydrates attached to the surface of a protein.
Dissolution and Comparative Dissolution Studies: In Vitro dissolution is a method for predicting permeability, solubility, and dissolution for oral bioavailability and bioequivalence for oral dosage forms.
Content Uniformity: This is to determine the quantity and uniformity of an active ingredient in a tablet or a solid dosage form.
Assay: This is to determine the quantity of an active ingredient in a tablet or a solid dosage form. The most common assay (potency) is an HPLC method.
Water Content (LOD; Loss On Drying): These are methods to quantitate residual water in the product.
Mass Spectrometry: This is an analytical technique that is used to identify unknown compounds, to quantify known compounds, and to elucidate the molecular structure, structural modifications and chemical properties of both small molecule compounds and large proteins. It can be used for:

Impurity Profiling for both small molecule compounds and macromolecules
Protein Sequencing and Structural Analysis
N- and C-Terminal Sequencing
Identifying Sites of Chemical Modifications
Characterization of Peptide Maps
Disulphide Bond Pattern Determination
Characterize Scale-up Processes

Method Qualification and Validation: These studies are designed to demonstrate that the procedure is suitable for its intended purpose. Validation characteristics (linearity, accuracy, precision) provide a sound and overall knowledge of the capabilities of the analytical procedure.
Bioanalytical Methods Development and Validation for:

In-vitro studies
In-vivo studies

CMC Compiling Services: This is the Chemistry, Manufacturing and Control section of the Regulatory Submissions to the FDA or other regulatory agencies.
Regulatory Guidance Services: We provide guidance in setting appropriate specifications, method development and validation, formulations, and conduct of stability studies for successful CMC submissions.
Compliance Levels: GLPs and cGMPs.

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