Immune monitoring services for advanced therapies
Immune profiling services for immune biomarkers, TCR and BCR sequencing, and custom gene expression assays.
Our immune profiling services
Protein immune biomarker analysis
Our immune biomarker analysis services use affinity-based proteomics (Olink) for high-throughput immune profiling and detection of inflammatory biomarkers in small blood and plasma sample volumes. These assays support clinical immune monitoring, helping identify key inflammatory biomarkers for disease progression and treatment response.
TCR and BCR sequencing for immune repertoire analysis
TCR and BCR sequencing to characterize the immune repertoire and track clonal diversity in immunotherapy and disease research.
GLP and GCLP compliant laboratory
We are accredited for Good Laboratory Practice (GLP) by the Swedish Board for Accreditation and Conformity Assessment (SWEDAC) for qPCR, dPCR, and molecular biology. In addition, we are Good Clinical Laboratory Practice (GCLP) compliant to ensure the safe and reliable analysis of clinical samples.
Immunogenicity testing is essential in the bioanalysis of cell and gene therapies, vaccines, and biologics. It is conducted during preclinical studies to ensure that efficacy data is not biased by immune-mediated degradation of the drug product. In clinical studies, immunogenicity testing is used as an inclusion/exclusion criterion, and post-administration immunogenicity testing is used to assess safety, efficacy, and persistence.
Pre-existing antibodies against adenoviruses, vaccines, and biologics can impact therapeutic efficacy, degrade the drug product, and, in the case of AAV therapeutics, hinder efficient cell transduction and lead to the elimination of transduced cells. The immunogenicity must be considered in all bioanalyses, including pharmacokinetics (PK), biodistribution, and shedding studies. If pre-existing antibodies are present, they can affect transgene protein expression, potentially compromising the reliability of PK, biodistribution, and shedding data.
For gene therapies, understanding the immune status of each treated individual is crucial for determining efficacy, safety, and dosing strategies. In clinical trials, pre-existing antibodies should be monitored to predict therapeutic response and post-dose immune responses should be assessed to evaluate safety, efficacy, and persistence.
The immune system and its response to foreign substances are highly complex. If an individual has been previously exposed to an agent, they may have acquired adaptive immunity, which includes a humoral B-cell-dependent antibody response and a T-cell-mediated cellular response. Upon encountering new foreign agents, the immune system first initiates a reaction through the innate immune system, often involving cytokine cascades to recruit and activate immune cells. Over time, this leads to the development of adaptive immunity.
A significant portion of the population has been infected with non-pathogenic adenoviruses and has acquired adaptive immunity. In AAV therapeutics, AAVs are generally not considered potent elicitors of innate or adaptive immune responses compared to natural adenoviruses. This is due to strategies such as codon optimization, CpG reduction, incorporation of regulatory elements, lower dosing, and immunomodulation to evade the immune response. However, the immune response to AAV therapeutics remains complex due to their multi-component nature, including the capsid, nucleic acid content, and translated gene product, which may be recognized as foreign by the immune system.
Resources
Overview of bioanalysis in advanced therapies
- Assay design and validation
- Regulatory guidelines (EMA and FDA)
- Challenges and best practices
Genomic biomarker analysis (DNA, RNA, miRNA, ctDNA etc,)
- Technology overview
- Analytical validation
- Regulatory overview
Capability PDF
Download our latest brochure for a summary of our molecular CRO services and capabilities.