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Antibody Analytics

Glasgow, UK, GB

Antibody Analytics designs and develops beautiful bioassays to support biopharmaceutical development. Using industry leading know-how and state of the art processes, we have accelerated the development pipelines for some of the leading biotech companies in the world.

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Mixed Lymphocyte Reactions
Price on request

Our MLR assays provide a useful platform to determine the effects of antibodies and compounds on the ability of T cells to be activated and proliferate. Drug treatment that increases T cell proliferation and production of cytokines such as IFN-g in the MLR would indicate its potential ability to mount anti-tumour T cell responses... Show more »

Our MLR assays provide a useful platform to determine the effects of antibodies and compounds on the ability of T cells to be activated and proliferate. Drug treatment that increases T cell proliferation and production of cytokines such as IFN-g in the MLR would indicate its potential ability to mount anti-tumour T cell responses in the tumour microenvironment.

Various sources of APCs and modes of their activation/maturation can be used in our MLR assay such as:
1. Monocytes (CD14+ cells purified from PBMC of healthy donors)
2. Monocyte-derived dendritic cells (CD14+ cells purified from PBMC of healthy donors cultured for seven days in the presence of GM-CSF and IL-4)
3. M1 or M2 macrophages (CD14+ cells purified from PBMC of healthy donors cultured for seven days in the presence of GM-CSF or M-CSF, respectively)
4. APC can be matured using a variety of factors, LPS (and other TLR ligands) being the most common.

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Oncology
assay development
Potency Assay
Biologics
Immunooncology
Inflammation
FACS
Cell-based assays
Biosimilar
monoclonal antibodies
Method Development
Biosimilarity analysis
Drug development
Biopharmaceuticals
Biologics
functional assays
anti-cancer
ADCC and CDC Assay Services
Price on request

ADCC (antibody-dependent cellular cytotoxicity) is an immune defence mechanism in which certain cells of the body are targeted for destruction by antibodies and subsequently killed by effector cells of the immune system. Many therapeutic antibodies and antibody-like proteins can harness and direct this killing activity towards... Show more »

ADCC (antibody-dependent cellular cytotoxicity) is an immune defence mechanism in which certain cells of the body are targeted for destruction by antibodies and subsequently killed by effector cells of the immune system. Many therapeutic antibodies and antibody-like proteins can harness and direct this killing activity towards cell types that express the antigen to which they're directed. Characterising the in vitro activity and establishing the potential influence on clinical efficacy poses one of the greatest challenges to biosimilar developers.

Antibody Analytics has developed a revolutionary approach and offers services based upon a proprietary advanced ADCC platform technology. Using novel cell lines and approaches we have eliminated the issues associated with traditional performance of ADCC assays and are able to provide elegant methods that measure target cell death with varying levels of biological relevance and sensitivity, all with unprecedented levels of performance and consistency.

Methodologies based upon the advanced ADCC assay platform are able to play a pivotal role in any biosimilar ADCC characerisation strategy adding significant value by providing data of the highest possible quality.

Expertise in ADCC Characterisation Strategies

No single approach can be applied to characterise the ADCC activity of a biosimilar and a successful ADCC characterisation strategy is dependent upon the (multiple) mechanism of actions of the innovator drug, its approved indications and most importantly, upon the observed activity of the biosimilar candidate itself relative to the reference innovator molecule. An ADCC evaluation strategy must therefore encompass a range of orthogonal analytical techniques that range from relatively simply CD16a (Fcγ Receptor IIIa) binding assessments to cell based ADCC assays. The complexity of ADCC assays can significantly increase as the nature of target and effector cell preparations are varied to meet specific objectives of the characterisation strategy.

Our experts have an unparalleled understanding of ADCC assay performance combined with industry leading expertise in the design and implementation of ADCC characterisation strategies. With knowledge gleaned from different biosimilar molecules that demonstrate a diverse range of similarity relative to the reference innovator product, we can help define a successful ADCC characterisation strategy for your biosimilar and perform the required experiments.

Our ADCC characterisation services include CD16a (Fcγ Receptor IIIa) binding assays, cell based binding assays (ELISA and Flow Cytometry) for measurement of antibody-antigen at the cell membrane and a range of methods based upon the advanced ADCC assay platform and a diverse range of investigatory ADCC assay formats that, together, are designed to truly understand the biological relevance and clinical significance of differences in ADCC activity. We can provide ADCC characterisation services for the following biosimilar molecules.

Adalimumab (Humira)
Bevacizumab (Avastin)
Denosumab (Prolia)
Etanercept (Enbrel)
Golimumab (Simponi)
Infliximab (Remicade)
Rituximab (Rituxan/MabThera)
Tocilizumab (Actemra)
Trastuzumab (Herceptin)
Ustekinumab (Stelara)

CDC Assays
The complement system plays a pivotal role in the innate immune system acting as an effector of adaptive immunity to remove common pathogens and unwanted cell types. The complement system can be activated through three major pathways: the classical, alternative and mannose-binding lectin. With relevance to therapeutic antibodies, the classical pathway is activated following binding of the C1 complex (C1q with C1r and C1s serine proteases) to the Fc region of a complement-fixing antibody that is bound to a target cell, initiating the complement cascade to kill cells through a process called complement-dependent cytotoxicity (CDC).

Determination of CDC activity of a biosimilars antibody should initially be conducted using a testing strategy composed of two orthogonal methods (a C1q binding assessment combined with a functional cell based CDC assay format) to determine the levels of similarity between the biosimilar and the reference innovator product. Where necessary, a range of investigatory assay formats can be applied to determine the significance of any differences on clinical efficacy and safety to demonstrate similarity.

Expertise in CDC Characterisation Strategies

Of the numerous effector function strategies that are employed to characterise biosimilars, a CDC assessment is probably the most simplistic as the number of required assay formats is reduced and those that are employed are less technically demanding than ADCC and ADCP. However, CDC activity of biosimimlar is still significantly influenced by certain product attributes that can vary between a biosimilar and the reference innovator product and it is critical that both C1q binding assays and functional cell based CDC assays demonstrate sufficient sensitive to these known product attributes and behave, together, as orthogonal methods.

Our experts are industry leaders in the understanding of the requirements for effector function characterisation having worked with a range of different biosimilar molecules that demonstrate a diverse range of similarity relative to the reference innovator product. With a wide portfolio of assays for different biosimilar molecules, we can help define a successful CDC characterisation strategy for your biosimilar and perform the required experiments.

Our CDC characterisation services include C1q binding assays, functional cell based methods using novel cell lines coupled with capabilities to conduct a diverse range of investigatory CDC assay formats for the following molecules:

Adalimumab (Humira)
Bevacizumab (Avastin)
Denosumab (Prolia)
Etanercept (Enbrel)
Golimumab (Simponi)
Infliximab (Remicade)
Rituximab (Rituxan/MabThera)
Tocilizumab (Actemra)
Trastuzumab (Herceptin)
Ustekinumab (Stelara)

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Cancer
Oncology
Rheumatoid Arthritis
Biology
assay development
Potency Assay
Antibodies
Oncology
Immunooncology
Immunooncology
Cancer
Cell-based assays
autoimmune
inflammation
Biosimilar
Biotherapeutics
monoclonal antibodies
assay optimization
bioassay
Crohn's Disease
Method Development
Biosimilarity analysis
In vitro bioassays
HER2
functional assays
VEGFR2
Cytotoxic T Cell Assays
Price on request

The biological activity of T-cell engaging bispecific antibodies can be determined using TDCC (T-Cell Dependent Cellular Cytotoxicity) assays supported with CD3-antigen binding assays. The TDCC assay follows a similar format to that of the ADCC assay, in which the bispecific forms a bridge between target cells expressing and... Show more »

The biological activity of T-cell engaging bispecific antibodies can be determined using TDCC (T-Cell Dependent Cellular Cytotoxicity) assays supported with CD3-antigen binding assays. The TDCC assay follows a similar format to that of the ADCC assay, in which the bispecific forms a bridge between target cells expressing and T-cells present within the effector preparation. As with ADCC assays, TDCC assays are complex methods with many formats requiring the use of primary cell types and expertise to run successfully.

With proprietary cell lines expressing common bispecific antigen targets, cell line development capabilities and access to a wide variety of primary T cells, we can develop industry-leading TDCC assays to support early screening activities through to development of lot release potency methods.

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Immunology
Cell biology
Oncology
Flow cytometry
inflammatory
assay development
Potency Assay
Biologics
Cytotoxicity
Immunooncology
Inflammation
FACS
Cell-based assays
monoclonal antibodies
assay optimization
bioassay
Method Development
Biosimilarity analysis
Drug development
Biopharmaceuticals
Biologics
In vitro bioassays
functional assays
ADCP Assay
Antibody-Dependent Cell-Mediated Phagocytosis Assay
Price on request

With regulatory agencies requesting a primary cell ADCP format more regularly, Antibody Analytics has developed an assay format that, although technically challenging, directly measures the engulfment of the target cells by CD14+ effector cells.

  • Established network of over 75 genotyped donors
  • Using cryopreservation, we can... Show more »

With regulatory agencies requesting a primary cell ADCP format more regularly, Antibody Analytics has developed an assay format that, although technically challenging, directly measures the engulfment of the target cells by CD14+ effector cells.

  • Established network of over 75 genotyped donors
  • Using cryopreservation, we can analyse up to 100 ADCP samples from a single collection
  • Highly accurate, reliable and repeatable format
  • Allows for quantitative and/or qualitative data reporting
  • The most informative means of determining if structural differences between molecules that are likely to manifest as differences in clinical efficacy
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Immunology
Oncology
Flow cytometry
Biology
Drug discovery
assay development
Potency Assay
Cytotoxicity
Immunooncology
Inflammation
FACS
Biosimilar
monoclonal antibodies
assay optimization
bioassay
Method Development
Biosimilarity analysis
Biopharmaceuticals
Biologics
In vitro bioassays
functional assays
Biosimilar Assay Development
Price on request

Custom design, development and qualification of biosimilar assays to support biopharmaceutical development. Currently have assays to support the following molecules:

Adalimumab (Humira)
Bevacizumab (Avastin)
Denosumab (Prolia)
Etanercept (Enbrel)
Golimumab (Simponi)
Infliximab (Remicade)
Rituximab... Show more »

Custom design, development and qualification of biosimilar assays to support biopharmaceutical development. Currently have assays to support the following molecules:

Adalimumab (Humira)
Bevacizumab (Avastin)
Denosumab (Prolia)
Etanercept (Enbrel)
Golimumab (Simponi)
Infliximab (Remicade)
Rituximab (Rituxan/MabThera)
Tocilizumab (Actemra)
Trastuzumab (Herceptin)
Ustekinumab (Stelara)

If your molecule is not listed, please get int touch, as we are constantly developing to support the global biosimilar market

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Flow cytometry
assay development
Potency Assay
FACS
Cell-based assays
assay optimization
bioassay
Method Development
ligand binding assays
Biosimilarity analysis
In vitro bioassays
functional assays
Cell Viability & Proliferation Assays
Price on request

Custom design, development and qualification of cell viability and proliferation assays to support biopharmaceutical development.

Custom design, development and qualification of cell viability and proliferation assays to support biopharmaceutical development.

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Flow cytometry
assay development
Potency Assay
Cytotoxicity
FACS
Cell-based assays
assay optimization
bioassay
proliferation
Method Development
Biosimilarity analysis
In vitro bioassays
functional assays
Cell Proliferation Assays
Apoptosis Assays
Price on request

Custom design, development and qualification of cell death and apoptosis assays to support biopharmaceutical development.

Custom design, development and qualification of cell death and apoptosis assays to support biopharmaceutical development.

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in vitro toxicity
assay development
Potency Assay
Cytotoxicity
Cell-based assays
assay optimization
bioassay
Method Development
Biosimilarity analysis
In vitro bioassays
functional assays
Biosimilars/Biobetters
Price on request

The Antibody Analytics management team have been providing biosimilar characterisation services for over 5 years working across a wide variety of assay formats and molecules and offer characterisation services based upon the following biosimilar molecules/methods:

Adalimumab (Humira): TNF-alpha binding and cell based TNF-alpha... Show more »

The Antibody Analytics management team have been providing biosimilar characterisation services for over 5 years working across a wide variety of assay formats and molecules and offer characterisation services based upon the following biosimilar molecules/methods:

Adalimumab (Humira): TNF-alpha binding and cell based TNF-alpha neutralisation bioassays
Bevacizumab (Avastin): VEGF binding and cell based VEGF neutralisation bioassays
Denosumab (Prolia): RANKL binding and cell based RANKL neutralisation bioassays
Etanercept (Enbrel): TNF-alpha binding and cell based TNF-alpha neutralisation bioassays
Golimumab (Simponi): TNF-alpha binding and cell based TNF-alpha neutralisation bioassays
Infliximab (Remicade): TNF-alpha binding and cell based TNF-alpha neutralisation bioassays
Tocilizumab (Actemra): IL-6R binding and cell based IL-6 neutralisation bioassays
Ustekinumab (Stelara): IL-12 binding and cell based IL-12 neutralisation bioassay

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Flow cytometry
assay development
Potency Assay
Cytotoxicity
FACS
Cell-based assays
Cytokine analysis
assay optimization
bioassay
Method Development
ligand binding assays
Biosimilarity analysis
In vitro bioassays
functional assays
Cell-Based Assays
Price on request

Binding and Cell Based Potency Assays

The potency of a therapeutic biologic is most commonly determined using a cell based bioassay and is frequently supported by a complimentary binding assay that is based upon the primary mechanism of action (MOA) of the therapeutic. Such methods play a critical role at all stages of... Show more »

Binding and Cell Based Potency Assays

The potency of a therapeutic biologic is most commonly determined using a cell based bioassay and is frequently supported by a complimentary binding assay that is based upon the primary mechanism of action (MOA) of the therapeutic. Such methods play a critical role at all stages of product development and are essential tools that are employed during clone selection, process development and optimisation and will ultimately feature as the most critical of the lot release assays.

The importance of getting the method correct cannot be overstated and considerably attention should be applied during development to ensuring that robust methods are built in line with best practices, provide consistent, accurate and precise results over time and are stability indicating. With a comprehensive knowledge of the bioassay requirements across clinical phases and therapeutics classes, Antibody Analytics offers a range of best-in-class binding and cell based assays to characterise biosimilars using QuBas Bioassay Software and can apply our expertise to develop high quality potency methods for novel therapeutics.

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Functional T-cell Suppression Assays
Price on request

Custom design, development and qualification of functional T-cell suppression assays to support biopharmaceutical development.

Custom design, development and qualification of functional T-cell suppression assays to support biopharmaceutical development.

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Cytotoxicity Assays
Price on request

Custom design, development and qualification of cytotoxicity assays to support biopharmaceutical development.

Custom design, development and qualification of cytotoxicity assays to support biopharmaceutical development.

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T Cell Activation and Proliferation Assays
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Immunoassays
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Biology
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Toxicology
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Pharmacology & Toxicology
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Bioavailability Studies
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ADME and DMPK Studies
Drug Metabolism and Pharmacokinetics
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Cell Death Assays
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Functional & Cell Type Specific Assays
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Immune Cell Assays
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