Download our Analytical Development Services brochure (PDF, 250KB)
Celsis Development Services provides the following comprehensive analytical development services. Each can be tailored to meet your specific needs and timelines.
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 supports the selection of the appropriate test methods to be used for product
release and stability monitoring.
In-process, bulk and drug product release testing: These tests are 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 and degradation 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.
| Analytical Services Provided |
- Chromatographic Separations
- Electrophoretic Separations
- Peptide Mapping
- Amino Acid Composition
- Determination of Product Concentration
- Residual Analysis (Examples: IPTG, Kenamycin, TritonX-100)
- Immunochemistry
- Western Blot
- ELISA (enzyme-linked immunosorbent assay)
- Sugar Analysis of Glycoproteins
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- Dissolution and Comparative Dissolution Studies
- Content Uniformity
- Potency Assay
- Water Content (Loss On Drying and Karl Fischer)
- Mass Spectrometry
- Impurity profiling for both small molecule compounds and macromolecules
- Protein sequencing and structural analysis
- N- and C-Terminal sequencing
- Identification of sites of chemical modifications
- Characterization of peptide maps
- Disulphide bond pattern determination
- Characterization support of scale-up processes
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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
- 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
Guidance in setting appropriate specifications, method development and validation, formulations and stability studies for successful CMC submissions.
Compliance Levels
GLP and cGMP
