Improved Characterization of IgG2 isoforms by LC-MS

2nd May 2019

Category: Bioanalytical / Biosimilars

By: Dr Martin De Cecco - Senior Scientist,

The majority of therapeutic mAbs developed so far belong to the IgG1 subclass, although some are IgG2 or IgG4. These different IgG subclasses differ in terms of the connectivity of their disulfide bonds. Whereas IgG1 molecules generally only have one defined structure, IgG2 antibodies can exist as three isoforms1, each with a different pattern of More

Comparative Assessment of mAb C1q Binding Using a Sensitive SPR Assay

21st January 2019

Category: Bioanalytical

By: Daniel O'Loughlin - Scientist, Technical Services,

Developing a Method for a Complex Molecular Interaction Effector functions such as complement dependent cytotoxicity (CDC) are important modes of action for many therapeutic monoclonal antibodies (mAbs). The degree of C1q binding and resultant CDC activity can influence the safety and efficacy of a mAb and therefore requires characterization during the development process. In addition, More

What is Mycoplasma?

11th January 2019

Category: Biosafety

By: Daniel Cozens - Biosafety Scientist,

Mycoplasmas are the smallest self-replicating organisms currently known to science. Common in nature, they are a group of simple bacteria characterized by a lack of a cell wall and a small genome. Many Mycoplasma species are found in the respiratory tracts of animals, where they have been associated with disease. For example, Mycoplasma pneumoniae is More

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

Regulatory Standards for Sterility Testing

12th October 2018

Category: Biosafety

By: Daniel Cozens - Biosafety Scientist,

What is Sterility Testing? During the production of biopharmaceuticals, contaminating microorganisms can enter the process at many stages. Once introduced, bacteria or fungi can replicate exponentially, severely compromising the final product. The presence of microorganisms in vaccines and other biopharmaceuticals can over time both spoil the product and pose a major risk to patient health. More

Biosafety Testing Throughout the Drug Development Cycle

12th September 2018

Category: Biosafety

Tags: ,

By: Daniel Cozens - Biosafety Scientist,

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

Tags: ,

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

Tags: , ,

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

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