Cell-based assay
From immunogenicity testing under GLP/GCP to batch release testing under GMP, we are ready to support both your development phases and final product release testing maximizing your success.
A cell-based assay provides a comprehensive view of the biological activity of newly developed drugs as well as biosimilars.
Cell-based Assay
Our biologics analysis department offers comprehensive services including dedicated Cell-bassed assay for:
- Preparation and storage of cell banks (working and master cell banks) with ccrtification to handle Genetically Modified Organisms (GMO) Class 1 and Class 2.
- Feasibility studies.
- Method Development.
- Method Transfer.
- Method Qualification and Validation.
With GMP, GLP, and GCP certifications, we are able to support your preclinical and clinical phases as well as routine quality testing.
- Certified to operate under GMP, GCP, and GLP.
- Approved for handling GMO Class 1 and Class 2.
Our Cell-based assay laboratory is equipped with the highest quality equipment to ensure a smooth operation for your analyses
- Biohazard boxes Class II – to protect both the sample and the operator.
- CO₂ incubators with controlled and monitored environments – to ensure stable cultivation conditions.
- Automated cell counter compliant with 21 CFR Part 11 – for morphology and viability monitoring.
- Dewar vessel with temperature monitoring – a safe storage solution for cell banks.
- Agilent Synergy H1 plate reader.
- Stegmann Systems PLA software for statistical evaluation.
Combine cell-based assays with ELISA, ADA determination, and QC testing to obtain a complete picture of your drug’s behavior across both preclinical and clinical phases.
Quinta – Analytica’s capabilities extend beyond Cell-based laboratory. We handle complex projects across various domains of the pharmaceutical industry, including, Biologics Quality Control, small molecule analysis, analytical R&D, bioanalytical testing, and clinical studies. Our comprehensive services ensure we meet the diverse needs of our clients, providing high-quality solutions for every stage of drug development.
Do you need any other services in the pharmaceutical industry such as formulation, GMP manufacturing of IMP or batch release? Take a look at the solutions provided within our Conscio Group.
Full GMP Batch Release Assay
Regulatory authorities require (if possible) implementation of a cell-based assay for every new batch of biologics to establish consistent biological activity. QC release consists of multiple tests, such as concentration, purity, and osmolality. We are equipped to coordinate all required assays for your full GMP batch release, ensuring compliance with the latest standards.
Immunogenicity Testing
Anti-Drug Antibodies (ADAs), especially neutralizing ADAs, are key analytes measured after administration of an immunogenic drug to the organism (e.g., animals in the preclinical phase or patients in the clinical phase of the study). Neutralizing antibodies (NAbs) are particularly important as they can inhibit the efficacy of the drug itself. To measure NAbs, competitive ligand-binding assays or, preferably, cell-based assays are established. We can measure both animal and clinical samples under GLP and GCP compliance.
Stability Testing
Oxidation, UV exposure, changes in pH or temperature – your drug can encounter all these stress conditions in different matrices. The most reliable method to evaluate changes in biological activity following such exposures is a cell-based assay.
Support for Cleanability Studies
Determining the residual biological activity after treatment with a disinfectant agent can support your manufacturer’s cleaning validation process. Our cell-based assays are designed to evaluate the effectiveness of your cleaning procedures with precision.
Screening Assay of candidate molecules
Selecting the best candidate molecule during preclinical discovery is a crucial and often complex process in biologics development. Using cell-based assays, we can help you identify the most promising clone in terms of biological activity and functionality.
Small Molecule Drug Testing
While cell-based assays are widely used for biologics, they are also powerful tools in evaluating small molecule drugs, particularly in functional cellular assays. We can assess the mechanism of action, receptor activation or inhibition, and downstream signaling effects, helping you bridge the gap between in-vitro data and in-vivo relevance.
Other supporting Services
Cell-based assays are invaluable for assessing biological activity after changes in production processes, formulation buffers, drug-to-antibody ratios (DAR) in Antibody-Drug Conjugates (ADCs), or payloads in ADCs. We also provide assays to evaluate bystander killing effects or immune cell responses, such as Mixed Lymphocyte Reactions (MLR). We are equipped to support a wide range of development-stage testing needs.
Additional Services
NITROSAMINES ANALYSIS
Based on isotopically labeled standards, our customizable in-house detection methods are available immediately.
MONITORING OF STUDIES
Oversight of participant health and correctness of treatments during clinical studies.
PHARMACOVIGILANCE
Monitoring of daily routine to detect unrecognized adverse events, plus assess and ensure drug safety.
MODULE 3 AUDIT
Thorough dossier M3 data audit to ensure consistency and compliance with regulatory requirements.
IMPD COMPILATION
As an EU based company we are well-placed to help create & develop your IMPD.
Questions?
Our Sales team is ready to help: sales@quinta.cz
Questions?
Please use the contact details or form below.
quinta@quinta.cz
+420 242 454 311
