Bioassay Products & Services

Bioassay in-vivo and in-vitro biopharma efficacy assays


Bioassay in-vivo and in-vitro biopharma efficacy assays


Bioassay Logo 150 x 36

Products & Services | Bioassay GmbH

Overview

Bioassay GmbH laboratories possess the expertise and facilities required to perform biopharma efficacy assays, both in-vivo and in-vitro.

Bioassay’s established in-vivo and in-vitro efficacy models can accurately characterize the properties of active pharmaceutical ingredients and drugs and their therapeutic efficacy against targeted indications.

The wide range of validated Bioassay efficacy models are particularly applicable to biopharmaceuticals like monoclonal Antibodies, Hormones or Cytokines, along with biosimilars or modified biologics, such as pegylated products.

The Bioassay laboratories also provide specialized models to characterize nephrology and diabetes drug candidates.

In-vitro efficacy bioassays

Analytical teams at Bioassay’s 1000 m2 laboratories at Heidelberg Technology Park use in-vitro facilities with state-of-the-art-equipment to 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 in-vitro efficacy assays covering cell-based analysis, FACS-Based Receptor Binding Assays, specific cell line development and neutralizing antibodies.

In-vivo efficacy bioassays

Bioassay has developed an extensive range of validated in vivo models of human disease to support preclinical drug efficacy testing. This range of efficacy assays can assist clients in choosing the correct pharmacodynamic (PD) or disease-specific model for selecting candidates, optimizing leads or validating targets.

Bioassay’s in vivo studies are fully supported by expertise in histopathology and bioanalysis to assess and interpret how the studied therapy affects disease pathogenesis. In-vivo efficacy assays cover a series of commercially relevant fields, including:

  • Nephrology models
  • Immunotoxicology (ITOX3-Panel)
  • LLNA

Nephrology Models
Bioassay’s In-vivo Efficacy models use in-house developed technologies that cover key study areas such as:

  • Acute Kidney Injury: (ischemia, inflammation, endothelial und tubular cell death)
  • 5/6 Nephrectomy: (glomerular hypertension and glomerulosclerosis)
  • Unilateral Ureteral Obstruction: (loss of renal parenchyma and fibrosis)
  • 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: (Streptozotocin > mild diabetic nephropathy, insulin-dependent) Diabetes Mutation: (BTBR Ob/Ob mice)

In House In-vivo analyses can cover:

  • Direct Organ Function
  • Hematology
  • 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)

Immunotoxicity assays
Bioassay’s in-vivo analysis in rat models can establish:

  • Immunophenotyping (Flow Cytometry)
  • Oral or parenteral administration of test samples
  • Immunophenotyping in target organs: blood, spleen, lymph nodes and bone marrow
  • Standardization by ITOX3-Kit (Beckman Coulter method)
  • 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)

LLNA assays
Bioassay can conduct Local Lymph Node Assay (LLNA) studies for skin sensitization using BrdU-ELISA techniques and conforming to OECD guideline 442B for determination of skin sensitization in the mouse.

These measure lymphocyte proliferation without disposal of radioactivity by a non-radio labelled 5-bromo-2-deoxyuridine (BrdU). BrdU is an analog of thimidine and is similarly incorporated into the DNA of proliferating cells.

Unlike traditional LLNA (429) techniques, the LLNA:BrdU-ELISA model can be used for testing nickel compounds.

These assays have further key advantages including:

  • No use of adjuvant required (compared to OECD 442A and 406)
  • Reduction and refinement of animal use (compared to OECD 406)

Specialized efficacy assays

For further products or to meet specific customer requirements, Bioassay has a comprehensive library of existing specialized assay formats. Its analysts can also develop customized efficacy assays at short notice.

Biopharma efficacy assays combine 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.

This combined approach enables Bioassay to extend the scope of its assay services.

Compliance and transparency

Bioassay conducts and documents all biopharma efficacy assays in conformity with 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.

Resources

Click on Bioassay Efficacy Assays for more information.
Click on Bioassay to contact the company directly.


Supplier Information
Supplier: Bioassay GmbH
Address: Im Neuenheimer Feld 515, D- 69120 Heidelberg, Germany
Tel: +49 6221 433 88 910
Fax: +49 6221 433 88 90
Website: www.bioassay-online.de


BioPharma ADCC and CDC Potency Assays


BioPharma ADCC and CDC Potency Assays


Bioassay Logo 150 x 36

Products & Services | Bioassay GmbH

Overview

Bioassay can perform high quality assays for Antibody Dependent Cell mediated Cytotoxicity (ADCC) Complement Dependent Cytotoxicity (CDC) as part of its BioPharma Potency portfolio.

Reliable and high quality ADCC & CDC assays have assumed greater significance with the growing importance in medicine of Therapeutic Antibodies (tAbs) and their role in combating cancers.

ADCC assay

Antibody Dependent Cell mediated Cytotoxicity is a prime mechanism of immune defense, along with Complement Dependent Cytotoxicity (CDC), attributed to the mode of action of several tAbs, in particular tumor cell targeting.

In ADCC, tumor cells (recognized by tAb) are targeted by natural killer cells by their FcγRIII (CD16) receptor binding to the Fc portion of the tAb followed by lysis of the target (tumor) cell (See Figure 1)

Bioassay’s ADCC assay is based on natural killer (NK) cells, delivering a readout for target cell lysis for a range of target cell lines, using purified NK effector cells. These include genotyped 158 V/F and 131 H/R NK cells, with quality controlled using flow cytometry based on CD16 and D56 marker expression.

Assay set up

Bioassay has established protocols for several tAb FACS-based ADCC Assays, with different stainings of target cells, such as PKH26, Calcein AM), tAb FcR, generic tumor cell and killer cell.

ADCC assays are Microtiter plate (MTP)-based with different cytotoxicity detection methods (e.g. Calcein AM, LDH, Alamar- Blue®, Delfia®)

For comparative ADCC potency testing, Bioassay uses a double controlled assay by measurement of fluorescence in supernatant (NK cell lysed) and direct lysis of remaining target cells (detergent lysed).

The assay produces a full logistic curve fitting with data readout driven by target cell lysis endpoint.

CDC Assay

Bioassay can also offer cGMP CDC assays that use normal human serum as the source of complement.

Complement-dependent cytotoxicity is the mechanism by which antibodies lyse unwanted targets by triggering a series complement-related reactions. Similar to ADCC, antibodies elicit ‘killing’ effects by binding Fc to serum complement components, particularly C1q, eventually forming a membrane attacking complex (MAC) that targets cell destruction. Typically CDC manifests as a vital mode of action in most therapeutic antibodies; enhancing the effect of ADCC. This is a complex process involving a wide spectrum of cellular elements, which means an effective CDC assay needs to consider many parameters in detecting, analysing and quantifying CDC activity in investigated antibodies.

Bioassay’s integrated CDC assay portfolio offers a high-quality complement system in human serum, complying with GLP and GMP guidelines. Sera from rodent species can be used as alternatives.

Multiple endpoints and readout formats are available, with typical endpoint by target cell lysis (e.g. LDH/ATP/GAPDH release or FACS screening). We can also design alternative assay readouts upon custom request.

A pre-proven CDC assay format features CD20 and TNFα and primary targets.

Compliance and transparency

All Bioassay biopharma potency assays are conducted in conformity with GLP & GMP standards, forming the basis for core 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.

Resources

Click on Bioassay ADCC/CDC Assays for more information.
Click on Bioassay to contact the company directly.

Figure 1: Basic ADCC Mechanism

Figure 1: Basic ADCC Mechanism

Example for MTP ADCC Assay: MabThera® (RTX) was used with 100% and 70% potency levels in comparative potency testing with Calcein AM fluorescence (vertical) and RTX dose (horizontal) shown as response parameters.  A 4-PL fit was used for potency determination, in this case showing estimated potency of 69.3% versus stated 70%, with relative confidence interval of 12.5%.

Example for MTP ADCC Assay: MabThera® (RTX) was used with 100% and 70% potency levels in comparative potency testing with Calcein AM fluorescence (vertical) and RTX dose (horizontal) shown as response parameters. A 4-PL fit was used for potency determination, in this case showing estimated potency of 69.3% versus stated 70%, with relative confidence interval of 12.5%.


Supplier Information
Supplier: Bioassay GmbH
Address: Im Neuenheimer Feld 515, D- 69120 Heidelberg, Germany
Tel: +49 6221 433 88 910
Fax: +49 6221 433 88 90
Website: www.bioassay-online.de


Skin Sensitization – Local Lymph Node Assay: BrdU – ELISA


Skin Sensitization – Local Lymph Node Assay: BrdU – ELISA


Bioassay Logo 150 x 36

Products & Services | Bioassay GmbH

To learn more about Bioassay’s Skin Sensitization – Local Lymph Node Assay: BrdU – ELISA, please click on the brochure below:

DOWNLOAD BROCHURE

DOWNLOAD BROCHURE

Resources

Click on Skin Sensitization – Local Lymph Node Assay: BrdU – ELISA for more information.
Click on Bioassay to contact the company directly.

Supplier Information
Supplier: Bioassay GmbH
Address: Im Neuenheimer Feld 515, D- 69120 Heidelberg, Germany
Tel: +49 6221 433 88 910
Fax: +49 6221 433 88 90
Website: www.bioassay-online.de

Bioanalytical Service – Immunotoxicity


Bioanalytical Service – Immunotoxicity


Bioassay Logo 150 x 36

Products & Services | Bioassay GmbH

To learn more about Bioassay’s Bioanalytical Service – Immunotoxicity, please click on the brochure below:

DOWNLOAD BROCHURE

DOWNLOAD BROCHURE

Resources

Click on Bioanalytical Service – Immunotoxicity for more information.
Click on Bioassay to contact the company directly.

Supplier Information
Supplier: Bioassay GmbH
Address: Im Neuenheimer Feld 515, D- 69120 Heidelberg, Germany
Tel: +49 6221 433 88 910
Fax: +49 6221 433 88 90
Website: www.bioassay-online.de

Nephrology Models – In-vivo Efficacy


Nephrology Models – In-vivo Efficacy


Bioassay Logo 150 x 36

Products & Services | Bioassay GmbH

To learn more about Bioassay’s Cell based Potency Assays, please click on the brochure below:

DOWNLOAD BROCHURE

DOWNLOAD BROCHURE

Resources

Click on Nephrology Models – In-vivo Efficacy for more information.
Click on Bioassay to contact the company directly.

Supplier Information
Supplier: Bioassay GmbH
Address: Im Neuenheimer Feld 515, D- 69120 Heidelberg, Germany
Tel: +49 6221 433 88 910
Fax: +49 6221 433 88 90
Website: www.bioassay-online.de

Cell based Potency Assays


Cell based Potency Assays


Bioassay Logo 150 x 36

Products & Services | Bioassay GmbH

To learn more about Bioassay’s Cell based Potency Assays, please click on the brochure below:

DOWNLOAD BROCHURE

DOWNLOAD BROCHURE

Resources

Click on Cell based Potency Assays for more information.
Click on Bioassay to contact the company directly.

Supplier Information
Supplier: Bioassay GmbH
Address: Im Neuenheimer Feld 515, D- 69120 Heidelberg, Germany
Tel: +49 6221 433 88 910
Fax: +49 6221 433 88 90
Website: www.bioassay-online.de

In-vivo and in-vitro potency bioassays


In-vivo and in-vitro potency bioassays


Bioassay Logo 150 x 36

Products & Services | Bioassay GmbH

Overview

Bioassay GmbH laboratories specialize in biopharma potency assays performed in-vivo and in-vitro.

Bioassay’s established in-vivo and in-vitro potency models can accurately assess quality control of active pharmaceutical ingredients and drugs. It also possesses extensive experience in developing and validating new assays under ICH-Guidelines, as well as optimizing existing assay formats for transfer into specific applications.

Bioassay GmbH has established a series of cGMP potency assays for antibodies, hormones, growth factors and Cytokines.

In-vitro potency bioassays

Bioassay’s analytical teams use in-vitro facilities with state-of-the-art-equipment at the company’s 1000 m2 laboratories at Heidelberg Technology Park to execute and assess potency 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 potency assays accordingly to ICH-Guidelines as well as in optimizing existing assay formats and transferring data into routine applications.

Bioassay’s In-vitro potency assay portfolio covers antibodies, hormones and growth factors.

Bioassay similarly offers potency assays to reflecting the diverse mechanisms of antibodies, notably trastuzumab, adalimumab, infliximab, and etanercept.

Bioassay in-vitro potency assays provide a range of ADCC and CDC testing solutions, as well as FACS-based binding assays.

In-vivo potency bioassays

The Erythropoietin potency assay determines biological activity of erythropoietin by quantitative reticulocyte counts in flow cytometry (FACS), using GMP-certified execution of a validated method according to European Pharmacopoeia monograph no. 1316. Daily routines and analysis of more than 500 test samples per year assure high quality data. Bioassay extensive experience in research on erythropoietin analogues includes participation in international round-robin testing and contribution to Pharmeuropa publications.

Bioassay can also predict the potency of Follicle Stimulating Hormone (FSH), Luteinising Hormone (LH) and Human Chorionic Gonadotropin (HCG).

Compliance and transparency

Bioassay conducts and documents all biopharma potency assays in conformity with 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.

Resources

Click on In-vivo and in-vitro potency bioassays for more information.
Click on Bioassay to contact the company directly.

Supplier Information
Supplier: Bioassay GmbH
Address: Im Neuenheimer Feld 515, D- 69120 Heidelberg, Germany
Tel: +49 6221 433 88 910
Fax: +49 6221 433 88 90
Website: www.bioassay-online.de

Cell based Potency Assays


Cell based Potency Assays


Bioassay Logo 150 x 36

Products & Services | Bioassay GmbH

To learn more about Cell based Potency Assays, please click on the brochure below:

DOWNLOAD BROCHURE

DOWNLOAD BROCHURE

Resources

Click on Cell based Potency Assays for more information.
Click on Bioassay to contact the company directly.

Supplier Information
Supplier: Bioassay GmbH
Address: Im Neuenheimer Feld 515, D- 69120 Heidelberg, Germany
Tel: +49 6221 433 88 910
Fax: +49 6221 433 88 90
Website: www.bioassay-online.de

Rituximab Binding Assay (FACS) using Raji cells


Rituximab Binding Assay (FACS) using Raji cells


Bioassay Logo 150 x 36

Products & Services | Bioassay GmbH

To learn more about Rituximab Binding Assay (FACS) using Raji cells, please click on the brochure below:

DOWNLOAD BROCHURE

DOWNLOAD BROCHURE

Resources

Click on Rituximab Binding Assay (FACS) using Raji cells for more information.
Click on Bioassay to contact the company directly.

Supplier Information
Supplier: Bioassay GmbH
Address: Im Neuenheimer Feld 515, D- 69120 Heidelberg, Germany
Tel: +49 6221 433 88 910
Fax: +49 6221 433 88 90
Website: www.bioassay-online.de

In Vitro and In Vivo Bioassays


In Vitro and In Vivo Bioassays


Bioassay Logo

Products & Services | Bioassay GmbH

To learn more about In Vitro and In Vivo Bioassays please click on the brochure below:

DOWNLOAD BROCHURE

DOWNLOAD BROCHURE

Resources

Click on In Vitro and In Vivo Bioassays for more information.
Click on Bioassay to contact the company directly.

Supplier Information
Supplier: Bioassay GmbH
Address: Im Neuenheimer Feld 515, D- 69120 Heidelberg, Germany
Tel: +49 6221 433 88 910
Fax: +49 6221 433 88 90
Website: www.bioassay-online.de

In Vivo Bioassays


In Vivo Bioassays


Bioassay Logo

Products & Services | Bioassay GmbH

To learn more about In Vivo Bioassays please click on the brochure below:

DOWNLOAD BROCHURE

DOWNLOAD BROCHURE

Resources

Click on In Vivo Bioassays for more information.
Click on Bioassay to contact the company directly.

Supplier Information
Supplier: Bioassay GmbH
Address: Im Neuenheimer Feld 515, D- 69120 Heidelberg, Germany
Tel: +49 6221 433 88 910
Fax: +49 6221 433 88 90
Website: www.bioassay-online.de


TNF-alpha Neutralisation Assay


TNF-alpha Neutralisation Assay


Bioassy Logo

Products & Services | Bioassay GmbH

To learn more about TNF-alpha Neutralisation Assay please click on the brochure below:

DOWNLOAD BROCHURE

DOWNLOAD BROCHURE

Resources

Click on TNF-alpha Neutralisation Assay for more information.
Click on Bioassay to contact the company directly.

Supplier Information
Supplier: Bioassay GmbH
Address: Im Neuenheimer Feld 515, D- 69120 Heidelberg, Germany
Tel: +49 6221 433 88 910
Fax: +49 6221 433 88 90
Website: www.bioassay-online.de


Antibody dependent cell cytotoxicity (ADCC)


Antibody dependent cell cytotoxicity (ADCC)


Bioassay Logo

Products & Services | Bioassay GmbH

To learn more about Antibody dependent cell cytotoxicity (ADCC) please click on the brochure below:

DOWNLOAD BROCHURE

DOWNLOAD BROCHURE

Resources

Click on Antibody dependent cell cytotoxicity (ADCC) for more information.
Click on Bioassay to contact the company directly.

Supplier Information
Supplier: Bioassay GmbH
Address: Im Neuenheimer Feld 515, D- 69120 Heidelberg, Germany
Tel: +49 6221 433 88 910
Fax: +49 6221 433 88 90
Website: www.bioassay-online.de


BioPharma Efficacy Assays


BioPharma Efficacy Assays


Bioassay logo

Products & Services | Bioassay GmbH

Overview

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
  • Hematology
  • 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)

Immunotoxicity

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.

Resources

Click on BioPharma Efficacy Assays for more information.
Click on Bioassay to contact the company directly.

Supplier Information
Supplier: Bioassay GmbH
Address: Im Neuenheimer Feld 515, D- 69120 Heidelberg, Germany
Tel: +49 6221 433 88 910
Fax: +49 6221 433 88 90
Website: www.bioassay-online.de


BioPharma Safety Assays


BioPharma Safety Assays


Bioassay Logo

Products & Services | Bioassay GmbH

Overview

BioPharma Safety is one of four key focus areas for Bioassay GmbH laboratories, along with BioPharma Efficacy, BioPharma Potency and Chemicals/Cosmetics Safety.

Bioassay’s analytical team, operating 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 safety assays within quality control and development regimes for a wide range of complex biopharmaceuticals and biotherapeutics.

Biopharma Safety Assays

Complex biotherapeutics interact with many different molecules in the human body to develop their mode of action. This increases the possibility of unwanted effects that 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 (mAbs) to any kind of recombinant proteins to characterize biotherapeutics in this respect.

Safety assay panels

Bioassay offers a panel of assays for assessment of complex biotherapeutics ranging from mAbs to recombinant proteins to characterize their interaction with different molecules in the human body to filter out possibilities of unwanted effects that might prejudice safety profile or compromise therapeutic efficacy.

Bioaasay offers a range of relevant biologics safety panels covering:

  • Antibody-dependent cellular cytotoxicity (ADCC)
  • Neutralizing antibodies
  • Multi-Cytokine Analysis
  • Immunotoxicity (iTox3)
  • Skin sensitization tests (LLNA, h-Clat, Keratinosens & MUSST)
  • Toxicokinetics

Compliance and transparency

Bioassay conducts and documents all biopharma safety 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.

Resources

Click on BioPharma Safety Assays for more information.
Click on Bioassay to contact the company directly.

Supplier Information
Supplier: Bioassay GmbH
Address: Im Neuenheimer Feld 515, D- 69120 Heidelberg, Germany
Tel: +49 6221 433 88 910
Fax: +49 6221 433 88 90
Website: www.bioassay-online.de


BioPharma Potency Assays


BioPharma Potency Assays


Bioassay Logo

Products & Services | Bioassay GmbH

Overview:

BioPharma Potency is one of four key focus areas for Bioassay GmbH laboratories, along with BioPharma Efficacy, BioPharma Safety and Chemicals / Cosmetics Safety.

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 potency 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 potency assays accordingly to ICH-Guidelines as well as in optimizing existing assay formats and transferring data into routine applications.

BioPharma Potency Portfolio

Bioassay has developed a series of established cGMP potency assays covering three different arenas:

Antibodies

  • Rituximab
  • Trastuzumab
  • Adalimumab
  • Infliximab
  • Etanercept
  • Antibody Dependent Cellular Cytotoxicity (ADCC)
  • Complement Dependent Cytotoxicity (CDC)
  • FACS-Based Binding Assays

Hormones

  • Erythropoietin
  • Follicle Stimulating Hormone (FSH)
  • Luteinising Hormone (LH)
  • Human Chorionic Gonadotropin (HCG)
  • Parathyroid Hormone (PTH)

Growth Factors & Cytokines

  • Filgrastim (G-CSF)
  • Human Growth Hormone (hGH)
  • Interleukins

Specialized potency assays

For further products or to meet specific customer requirements, Bioassay has a comprehensive library of existing specialized assay formats. Its analysts can also develop customized assays at short notice.

Biopharma potency assays combine 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.

This combined approach enables Bioassay to extend the scope of its assay services.

Compliance and transparency

Bioassay conducts and documents all biopharma potency 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.

Resources

Click on BioPharma Potency Assays for more information.
Click on Bioassay to contact the company directly.

Supplier Information
Supplier: Bioassay GmbH
Address: Im Neuenheimer Feld 515, D- 69120 Heidelberg, Germany
Tel: +49 6221 433 88 910
Fax: +49 6221 433 88 90
Website: www.bioassay-online.de