Cell-based bioassay development

We are proficient in developing the cell based assays for the determination of specific activity and biological characterization. Our bioassay expertise includes adherence to regulatory guidelines, such as Ph. Eur, USP, and ICH for the purpose of method development, optimization, qualification and validation.

Our Competence:

Fundamental understanding of the molecular mechanism of drug action both for clinical setting as well as in-vitro cell culture setting from published literature
Suitability of the assay for its intended purpose from published literature or any other scientific communication
Suitability of a platform technology (such as flow cytometry based assays) to be used for the development of the assay
Feasibility of developing the assay in terms of materials and reagent availability
Cost estimation for the assay to be put into routine use
Finding the authentic source of cell lines and their availability
Development experiments involving animal cell culture techniques and ELISA based techniques

Expertise and Technology:

Cell Proliferation Assays
Cytopathic Effect Reduction (CPER) Assay
Cell Based cAMP Release Assay
Competitive Receptor Binding (Flow Cytometry)
Reporter Gene Assay
CDC Assay
ADCC Assay
Antiproliferation Assay
Immunogenecity Assays (hyperlink)
Neutralizing Antibody Assays
ELISA platforms

Biological Characterization Studies:

Biological activity assays beyond lot release potency assay
- Receptor binding
- Intracellular events/markers
Specificity of the lot release assay
- Activity of other products of the sponsor
- Activity of related growth factors, cytokines
- Studies with neutralizing antibodies
Analysis of stressed samples
- Thermal degradation
- Forced Aggregation

Contract R&D services

Analytical Services

Contract Manufacturing

Cell-based bioassay development

Our Competence:

Expertise and Technology:

Biological Characterization Studies:

Contact