Safety & Potency
Safety - Immunogenicity testing
Recombinant proteins or antibodies may often lead to formation of anti-drug (ADA) or neutralizing antibodies (NADA) that might jeopardize a patient's safety.
To thoroughly determine the biopharmaceutical drug's immunogenic potential SYMBIOSIS follows a four-step immunogenicity testing strategy:
- Screening assay
- Confirmatory assay
- Titer assessment
- Detection of cell-based neutralizing antibodies
We work very closely with clients because each project contains unique challenges. SYMBIOSIS offers several approaches to immunogenicity testing to ensure that the most robust, sensitive and reliable techniques are employed.
Potency - Bioassays
SYMBIOSIS provides a dedicated one-stop-service from bioassay development to GMP batch release, helping to accelerate your testing programs. The measurement of the biological activity is a crucial test method required throughout the life cycle of all biopharmaceutical products. Our development and validation is based on US FDA Guidance for Industry. Potency assays are used for candidate selection, product characterization, assessment of clinical efficacy, comparability testing, stability studies and ultimately for the lot release of your product.
Our experienced team of scientists is experienced in performing assays following various modes of actions including:
At SYMBIOSIS we can perform virus-based assays (biosafety levels S1) according to Genetic Engineering Law (Gentechnikgesetz (GenTG). We also have the permission to work with pathogenic germs according to Infektionsschutzgesetz (IfSG).
During proof of concept studies we develop new methods or optimize non-routine assays by applying in-house expertise to generate robust bioassays. Using statistical-based approaches like parallel line assays or full logistic curve fits we are able to determine the most appropriate assay design. These are capable of meeting the rigorous demands of regulatory acceptance, whilst reducing the cost and timelines associated with the testing of your product.
Our capabilities include:
- Development of scientifically sound and cost effective cell banks qualified for your bioassay
- Validation of potency assays according to US FDA Guidance for Industry
- Establishment of criteria for critical reagents and define the specifications of the reference materials that will enable a measure of relative potency
- Cell bank storage and stability programs