Bioassay bioanalytical assay services

Bioassay GmbH offers a range of GxP compliant bioanalytical assay services from its Heidelberg laboratories in Germany. These include in-vivo and in-vitro assays for potency, efficacy pharmaceutical safety and chemical/cosmetic safety.

The Bioassay laboratory teams can execute and assess cell-based bioanalytical assays within established FDA/EMA and pharmacopeia quality control and development regimes for a wide range of active pharmaceutical ingredients (APIs) and drug products. Bioassay also has extended experience in developing and validating new assay to ICH guidelines as well as in optimizing existing assay formats and transferring data into routine applications.

Bioassay bioanalytical portfolio

Bioassay’s analytical teams use in-vivo and in-vitro facilities with state-of-the-art-equipment at the company’s 1000 m2 laboratories at Heidelberg Technology Park to conduct established cGMP and cGLP assays covering three different arenas:

Potency assays

A potency assay assesses a substance or drug’s ability to elicit required response within a biological system at particular doses. Validated potency assessment is a basic requirement for a regulatory agency to be able to certify as product as eligible for release. Potency assays are also useful for ranking of potential therapeutic drug candidates during the discovery process.

Bioassay can conduct both functional assays, assessing biological response,or ligand-binding potency assays, in which interaction of drug with target is quantified. The latter typically use enzyme-linked immunosorbent (ELISA) assays or flow cytometry. Functional assays may also use flow cytometry, in vitro cell-based assays or other formats. Cell-based potency assays often depend on antibodies as critical reagents in studying drug binding or assessing a drug’s functional effects. For Bioassay, these antibodies include Rituximab, Trastuzumab, Adalimumab, Infliximab and Etanercept.

Bioassay can also use FACS-Based Binding Assays and assess Antibody Dependent Cellular Cytotoxicity (ADCC) and Complement Dependent Cytotoxicity (CDC).

Its potency testing portfolio also uses hormones, including Erythropoietin, Follicle Stimulating Hormone (FSH), Luteinising Hormone (LH), Human Chorionic Gonadotropin (HCG), and Parathyroid Hormone (PTH) along with growth factors & cytokines, such as Filgrastim (G-CSF), Human Growth Hormone (hGH) and interleukins.

Bioassay combines standardized processes with flexible organization, adapting constantly to changing needs. Project managers are assigned to each customer at both operative and administrative levels, to accompany the client through all stages of their projects.

Efficacy assays

Bioassay established cGMP efficacy assays cover both Cell-based Analysis and Pharmacokinetic & Disease models. In both cases, the efficacy assay quantifies the response achievable from the pharmaceutical drug or substance in-vitro to as well as the therapeutic effect or beneficial change in-vivo.

Bioassay in-house efficacy analysis can cover such targets as Direct Organ Function, Hematology, ELISA (biomarkers: e.g. Kim-1, NGAL, NAG), FACS for peripheral blood/tissue, Multiplex Analysis of cytokines, Cell Analysis of inflammatory cells and renal tissue analysis using macrophages.

Bioassay’s Cell based Analysis can take three forms:

• FACS-Based Receptor Binding Assays: Using flow cytometry for accurate cell counting and sorting, biomarker detection, and protein engineering tasks. This 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 Cell Line 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
• 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

Bioassay’s Pharmacokinetic and Disease metabolic studies are based on in-vivo studies and validated in-house specific Nephrology & Diabetic Models, such as Acute Kidney Injury (AKI) / Ischemia-Reperfusion-Injury (IRI), Kidney transplantation model, 5/6 Nephrectomy (Chronic Kidney Disease): Unilateral Ureteral Obstruction (UUO), Diabetic Nephropathy, Renal Artery Stenosis, Renal Transplantation, Aortic Transplantation and Diabetes Induction or Mutation Models Streptozotocin to mild diabetic nephropathy, insulin-dependent.

Bioassay’s efficacy assays can also assess immunotoxicity using Immunophenotyping (Flow Cytometry), in-vivo analysis in rats, oral or parenteral administration of test samples, immunophenotyping in target organs: blood, spleen, lymph nodes and bone marrow, Beckman Coulter standardization by ITOX3-Kit, analysis of T-, B- and NK- Cells by CD3, CD4 and CD8 detection or calculation of cellularity index.

Safety assays

Bioassay’s safety assays assess the complex biotherapeutic interactions with many different molecules in the human body to develop their mode of action to check for possibilities of unwanted effects that might compromise patient safety profile or therapeutic efficacy. These safety assays use panels of validated assays based on monoclonal antibodies (mAbs) or recombinant proteins to characterize a biotherapeutic’s interaction with different molecules in the human body.

These panels include Antibody-dependent cellular cytotoxicity (ADCC), neutralizing antibodies, Multi-Cytokine Analysis, Immunotox Three-Color Combinations (iTox3), skin sensitization tests (LLNA, h-Clat & MUSST), and Toxicokinetics.

Bioassay’s endotoxin testing regimes include bacterial endotoxins testing in compliance with the European Pharmacopoeia (Ph. Eur.) Chapter 2.6.14., chromogenic testing: using endotoxin-activated LAL to cleave amino acid cleavage sites containing chromogenic peptides and turbidimetric testing, endotoxin content to be determined using optical density measurement.

Bioanalytical validation

Bioassay conducts and documents all biopharmaassays 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.