Tag: biosimilar development

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

Improved Product Quality of Biosimilars in the Cellca CHO Expression Platform

15th December 2017

Category: Biosimilars

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By: Cornelia Lindner - Team Leader, Dr Christoph Zehe - Lead Scientist, Johannes Wirth - Scientist, Marina Putanko - Scientist,

Due to the high number of patent expirations for first generation biopharmaceuticals, the production of biosimilars is a fast growing market. Biosimilars require finger-print like similarity to their originator drug with respect to product quality.  One important aspect of product quality is a comparable glycosylation pattern, as glycosylation influences serum clearance, immunogenicity, as well as More

What is the best way to approach biosimilar development?

27th March 2017

Category: Bioanalytical / Biosimilars

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By: Dr Terry Gray, Field Marketing Manager,

Part one Monoclonal antibodies have a highly specific targeted action which allows a reduction in side effects compared to small molecule drugs, which has seen them becoming a mainstay of modern medicine. The innate complexity of these molecules allows them to be potent drugs that activate molecular cascades within the immune system. So what does More

Piecing together the biosimilar puzzle: Physicochemical & Functional Analytics

Category: Bioanalytical / Biosimilars

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By: Dr Terry Gray, Field Marketing Manager,

Part two Read Part One. A fundamental feature of a mAb is its biological structure, as this defines the functional output of the biologic, as illustrated by Figure 2. Figure 2 – The interplay between the structure of a monoclonal antibody, the affinity for interaction and the resulting functional activity. Fundamentally, the sequence of a More

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