What is analytical development?

Analytical development is the process of developing and validating analytical methods for the testing of pharmaceutical products. It ensures the accuracy and reliability of product testing.

What are the different steps involved in analytical development?

The different steps in analytical development include method selection, method validation, method transfer, and method maintenance, ensuring accurate and reliable testing.

What are the benefits of outsourcing analytical development?

Outsourcing analytical development offers benefits such as access to specialized expertise, cost savings, faster turnaround times, and increased flexibility.

How can I get started with analytical development?

To begin with analytical development, contact a CRO to discuss your specific needs. The CRO will assess your requirements and provide a custom solution.

Analytical Chemistry

Synergy Bioscience has the expertise in developing analytical methods for a wide range of drug products, including small molecules and large protein molecules.

Services offered

Development of analytical methods for release testing.
Development and execution of characterization methods
Comparability studies
Purification and characterization of isomers, impurities, and degradants
In-process support during process development

Analytical Methods

Purity

SDS-PAGE or capillary electrophoresis-SDS
Isoelectric focusing (gel-based cIEF or imaged cIEF)
Ion-exchange HPLC
Size-exclusion HPLC
Reversed-phase or hydrophobic interaction HPLC
Host cell protein (HCP) ELISA
Residual DNA
Endotoxin

Primary Structure

Western blot
N-terminal Amino Acids sequencing
Peptide mapping for detailed primary sequence analysis by LC-MS/MS
Characterization of post-translational modifications by LC-MS/MS

Carbohydrate Analysis

Monosaccharide composition analysis
Sialic acid quantitation
N-linked glycan profiling (fluorescent HPLC and CE-LIF
Detailed glycan structural analysis by MALDI-TOF-MS and ESI-MS/MS

Functional Assays

Cell-based bioassay
Binding ELISA
Surface plasmon resonance (BIAcore) and isothermal titration calorimetry (ITC)

Protein Mass

High-resolution intact protein mass measurement by LC-ESI-MS
Intact protein mass measurement by MALDI-TOF-MS

Conformational Analysis

Circular dichroism (CD)
Fluorescence
Fourier transform infrared spectroscopy (FTIR)

Aggregation Analysis

Dynamic light-scattering (DLS)
Size-exclusion chromatography with multiangle laser light scattering (SEC-MALLS)
HIAC liquid particle counting system

Physical Properties

PH
Osmolality
Residual moisture by Karl Fischer

Process Residuals

Process residual analysis by spectrophotometric assay
HPLC, ELISA, or LC-MS/MS, including surfactants, methotrexate
Host cell protein (HCP)
Residual DNA (qPCR)
Endotoxin

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