BioPharma Efficacy Assays
Products & Services | Bioassay GmbH
BioPharma Efficacy is one of four key focus areas for Bioassay GmbH laboratories, alongside BioPharma Potency, BioPharma Safety and Chemicals / Cosmetics Safety.
Bioassay GmbH has established efficacy models that can accurately characterize new drugs, especially in the field of biopharmaceuticals like monoclonal Antibodies, Hormones or Cytokines. Bioassay GmbH also has extended experience in characterizing Biosimilars or modified Biologics, such as pegylated products.
The Bioassay laboratories also provide specialized models to characterize drug candidates in the fields of nephrology and diabetes.
BioPharma Efficacy Portfolio
Bioassay’s analytical teams using in-vivo and in-vitro facilities with state-of-the-art-equipment at the company’s 1000 m2 laboratories at Heidelberg Technology Park can execute and assess efficacy assays within quality control and development regimes for a wide range of active pharmaceutical ingredients (APIs) and drug products.
Further, Bioassay has extended experience in developing and validating new efficacy assays accordingly to ICH-Guidelines as well as in optimizing existing assay formats and transferring data into routine applications.
Bioassay has developed a series of established cGMP efficacy assays covering two different arenas:
Cell based Analysis
Bioassay offers three types of cell based efficacy analysis.
- FACS-Based Receptor Binding Assays: World-class flow cytometry analysis can perform accurate biomarker detection, and protein engineering tasks. Flow cytometry FACS analysis allows ability to analyze and measure cells individually, which is particularly useful when studying heterogeneous cell populations, allowing rapid analysis of subpopulations along with very detailed data on count, properties, and cell-by-cell classification.
- Specific Assay Development: Stable cell lines expressing recombinant targets such as ion channels and GPCRs are commonly used in a number of research applications including drug discovery screening and safety assessment. Bioassay has overseen generation of a range of functionally validated cell lines, including over-expression of membrane proteins. Bioassay cell line generation services can be tailored to client needs including choice of host cell, constitutive or inducible expression and customized validation.
- Neutralizing antibodies: A neutralizing antibodies (NAbs) are increasingly used in medicine as a way to defend target cells from antigens or infectious bodies by neutralizing any biologic effect, such as with diphtheria antitoxin. Bioassay can assess such NAbs for biologic efficacy.
Pharmacokinetic & Disease Models
Bioassay efficacy services also include pharmacokinetic and metabolic studies based on in-vivo study of efficacy and validated in-house models. These specific Nephrology & Diabetic Models include:
- Acute Kidney Injury (AKI) / Ischemia-Reperfusion-Injury (IRI): checking for ischemia, inflammation, endothelial und tubular cell death
- Kidney transplantation model
- 5/6 Nephrectomy (Chronic Kidney Disease): glomerular hypertension and glomerulosclerosis
- Unilateral Ureteral Obstruction (UUO): loss of renal parenchyma and fibrosis
- Diabetic nephropathy
- Renal Artery Stenosis: hypertension, renal fibrosis and tubular degeneration
- Renal Transplantation: acute and chronic allograft rejection
- Aortic Transplantation: vascular rejection and neo-intima formation
- Diabetes Induction Model: Streptozotocin to mild diabetic nephropathy, insulin-dependent
- Diabetes Mutation Model: BTBR Ob/Ob mice
In House Analysis:
Bioassay in-house efficacy analysis can cover:
- Direct Organ Function
- Light Cycler PCR (Renal tissue)
- ELISA (biomarkers: e.g. Kim-1, NGAL, NAG)
- FACS (peripheral blood/tissue)
- Multiplex Analysis (cytokines)
- Cell Analysis (inflammatory cells)
- Renal tissue analysis (macrophages)
Bioassay can assess immunotoxicity in a number of ways:
- Immunophenotyping (Flow Cytometry)
- In-vivo analysis (rat)
- Oral or parenteral administration of test samples
- Immunophenotyping 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)
Compliance and transparency
Bioassay conducts and documents all biopharma efficacy assays in conformity with GLP & GMP standards, which form the basis for its quality and reliability standards. This compliance guarantees acceptability of data generated for product acceptance and licensing.
Bioassay quality standards are inspected by leading regulatory authorities and in customer audits. These serve to encourage continuous improvement and reinforce transparency.
All customer-specific data and processes are handled and stored with utmost discretion and confidentiality.