Category: Bioanalytical

Reporter Bioassays: A cost & time effective alternative

3rd December 2018

Category: Bioanalytical

By: Lisa Blackwood - Scientist,

Whilst an in vivo bioassay method may be available, identifying a cell line that responds to a particular monoclonal antibody target or to the antibody itself, in both a specific and reproducible manner, can often be a hurdle in the development of a cell-based potency assay. This can prove to be a significant challenge in More

Why Use KILR Effector Cells for QC & Lot Release?

26th November 2018

Category: Bioanalytical

By: Laura McAleer, Technical Services Scientist,

Therapeutic monoclonal antibodies are able to bind to their target antigen and can also bind to Fc receptors found on the surface of effector immune cells. This results in target cell death by Antibody-Dependent Cell-mediated Cytotoxicity (ADCC). Traditional ADCC assays can be complex and require the use of freshly isolated primary human cells such as More

Scientist’s Review of BEBPA 2018

2nd November 2018

Category: Bioanalytical

By: Ben Tyrrell - Scientist, Laura McAleer, Technical Services Scientist,

At the end of September 2018 Sartorius Stedim BioOutsource attended the 11th Annual EUR BEBPA Bioassay conference in Budapest, Hungry. The conference ran over three days with the first day containing workshops and day 2-3 having talks and poster presentations. The aim of this conference was to provide discussions on topics of current interest to the More

Peptide Mapping by LC-MS: A Multi-Attribute Method for the Characterization of Therapeutic Proteins

23rd July 2018

Category: Bioanalytical

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By: Dr Martin De Cecco - Senior Scientist,

A hot topic in the field of biopharmaceutical analysis is the concept of a multi-attribute method (MAM)¹, i.e. the characterization of several different product quality attributes with a single assay. The appeal to developers of biotherapeutics is clear: more information from a smaller number of tests. Such an approach is in keeping with the principle More

The Impact of Human Serum on ADCC Assays

3rd July 2018

Category: Bioanalytical

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By: Laura McAleer, Technical Services Scientist,

Antibody-Dependent Cellular Cytotoxicity (ADCC) is a mechanism adopted by the immune system to remove infected or cancerous cells. Antibodies bind a specific antigen on the target cell surface, which in turn binds the FcγRIIIa receptor on effector cells (e.g Natural Killer (NK) Cells) via the Fc region, resulting in the lysis of the target cell. Although in More

Qualifying & Developing VEGF Binding Assay using an iQue® Screener PLUS

25th May 2018

Category: Bioanalytical

By: Ben Tyrrell - Scientist, Katie Chapple - Scientist,

The iQue® Screener PLUS, by Intellicyt (part of the Sartorius Group), is used at Sartorius Stedim BioOutsource to achieve a faster assay throughput and deliver an air-gap-deliminated flow of samples to the detectors. Bevacizumab is a humanized monoclonal antibody (mAb) which mediates its activity through a high affinity binding to VEGF (vascular endothelial growth factor). More

Robust & Reproducible ADCC with Single Donor KILR CD16 Effector Cells

23rd May 2018

Category: Bioanalytical

By: Laura McAleer, Technical Services Scientist, Lisa Blackwood - Scientist,

The success of ADCC (antibody-dependent cell-mediated cytotoxicity) depends on the quality of the effector cells used. Traditional ADCC assays can be complex and require freshly isolated primary human cells, such as PBMC (peripheral blood mononuclear cell) or NK (natural killer) cells. However these can have inter-individual variability. While NK cell lines engineered to overexpress CD16 are More

The Path to Protein Concentration Measurement

8th May 2018

Category: Bioanalytical

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By: Stuart Wright - Scientist,

Protein Concentration Analysis Quick and accurate measurement of protein concentration is very important within the biopharmaceutical industry. This must be carried out on a large number of samples prior to performing the various physicochemical analysis involved in protein characterization or protein structural analysis, since many assays depend on knowledge of the biotherapeutic protein concentration. However, More

Orthogonal Chromatographic Techniques for Therapeutic Protein Characterization

1st March 2018

Category: Bioanalytical

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By: Stuart Wright - Scientist,

Development of biotherapeutics, for example monoclonal antibodies (mAbs), requires a wide range of physicochemical and structural analysis to be undertaken in accordance with ICH Q6B guidelines. Each technique will assess different critical quality attributes (CQAs) which form part of the analytical characterization of the biotherapeutic. CQAs are properties or characteristics relating to physical, chemical, biological More

Characterization of Protein Structure: The Value of Intact Mass Analysis

26th February 2018

Category: Bioanalytical

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By: Dr Martin De Cecco - Senior Scientist,

Intact mass analysis is the assessment of a protein’s total molecular weight  by mass spectrometry (MS) without prior digestion or fragmentation of the molecule of interest. Molecular weight determination forms part of the ICH Q6B guidelines for physicochemical analysis of biological products: what use is this information in the analytical characterization of biopharmaceuticals? High resolution More

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