Bioassay Bioanalytical Contract Laboratory

Identify off-target interactions and achieve optimal specificity from your biotherapeutics

Our BioPharma Safety assays are designed to help you mitigate off-target interactions and to achieve optimal specificity from your new drug.

Complex biotherapeutics interact with many different molecules in the human body to develop their mode of action. This increases the possibility of unwanted effects which might result in an unacceptable safety profile or compromise therapeutic efficacy of a compound. Bioassay offers a panel of assays for assessment of monoclonal antibodies to any kind of recombinant proteins to characterize biotherapeutics in this respect.

Immunotoxicity

We can help you assess any adverse effect of your compound on the immune system, or on other systems as a result of immune system dysfunction.

In vitro and ex vivo analysis

Immunophenotyping (Flow Cytometry) in target organs: blood, spleen, lymph nodes and bone marrow
Standardization by ITOX3-Kit (Beckman Coulter)
Analysis of T-, B- and NK- cells by CD3, CD4 and CD8 detection
Calculation of a cellularity index (comparison to negative and positive Cyclophosphamide control)

In vivo analysis

Oral or parenteral administration of test samples
In vivo examination (rat)

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In vivo models

Specialized models for the characterization of drug candidates in the field of renal disease and diabetes.

Acute Kidney Injury (AKI) / Ischemia-Reperfusion- Injury (IRI)

Treatment related ischemia, inflammation, endothelial and tubular cell death

Chronic Kidney Disease models (5/6 nephrectomy)

Glomerular hypertension and glomerulosclerosis

Unilateral Ureteral Obstruction (UUO)

Loss of renal parenchyma and fibrosis

Renal Artery Stenosis

Hypertension, renal fibrosis and tubular degeneration

Spontaneous Diabetic Model

BTBR Ob/Ob mice

Induced Diabetes Model

Streptozotocin to mild diabetic nephropathy, insulin-dependent

Renal Transplantation Models

Acute and chronic allograft rejection

Aortic Transplantation

Vascular rejection and neo-intima formation

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Contact us to learn more about our assay development and testing services and how we can help you bring safe and effective drug products and biologics to market.

BioPharma Safety