Biosafety Testing Throughout the Drug Development Cycle

12th September 2018

Category: Biosafety

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By: Daniel Cozens - Scientist, Biosafety,

Biosafety Testing from Cell Line Development Through to Lot Release For the release of biopharmaceutical drugs onto the market, products must be shown to be safe. Regulatory bodies such as the US Food & Drug Administrators (FDA) and the Medicines and Healthcare Regulatory Agency (MHRA) require products are tested for compliance before release. This involves a More

Three Decades of Quantitative PCR

17th August 2018

Category: Biosafety

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By: Ifigeneia Stavrou - Biosafety Scientist,

In April of 1983 while on a late-night Friday “moonlit drive through the mountains of California” to his weekend cabin in Mendocino, Kary Mullis, a researcher at the Cetus Corporation biotechnology company, experienced a “Eureka” moment that would change the world forever (1). The idea made him stop the car on the side of the highway 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

Why Glycan Analysis is an Essential Part of Therapeutic Protein Characterization

4th January 2018

Category: Bioanalytical

By: Dr Martin De Cecco - Senior Scientist,

A recent report on the growth of the glycan analysis market¹ highlighted the importance of assessing the glycosylation of biotherapeutics. The carbohydrate structures attached to the crystallizable fragment (Fc) of monoclonal antibodies can influence efficacy and safety and so they are often classed as critical quality attributes. For this reason the analytical characterization of glycosylation More

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