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 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 biosimilar must match More

Choosing the right assay at the right time for biosimilar development

Category: Bioanalytical / Biosimilars

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By: Dr Terry Gray, Field Marketing Manager

Part three As highlighted in our previous blog articles, cost & throughput are important contributing factors to consider when developing a biosimilar. Another factor to consider is the choice of assay that will be used at each stage of the biosimilar product life cycle. There are two competing areas which drive the decision making process More

Preparing for future bioprocessing challenges with the Cellca CHO Expression Platform

13th July 2016

Category: Cell Line Development

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By: Dr. Brian Wendelburg, Sr. Field Marketing Manager

Therapeutic protein development and production is a very technically challenging, time consuming and expensive endeavor. What are some of the challenges? There are numerous critical decisions that must be made with regard to mammalian cell line choice (CHO, NS0, etc.), appropriate gene and marker expression systems, cell culture medium and feed optimization, clone selection and More

ELISA – Conception and Applications

19th August 2015

Category: Bioanalytical / Biosimilars

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By: Laura Munro, Technical Services Scientist

Since its conception in the early 1970’s the Enzyme Linked Immunosorbent Assay has been a primary method of analyte detection. In its four decades it has become a fundamental tool in a wide range of scientific fields, its diverse nature demonstrated by its range of uses. The ELISA was the first screening test widely used More

An Orthogonal Approach to ADCC Biosimilar Testing

Category: Biosimilars

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By: Debbie Allan PhD, 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. More

The Importance of Accurate Determination of ADCC Activity During Biosimilar Development

Category: Biosimilars

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By: Stefan Termen, Technical Services Scientist

Cells infected with enveloped viruses will express viral proteins on their cell membranes, and many cancer cells will express specific surface antigens. These proteins are recognized by antibodies of the humoral immune system as targets for Antibody-Dependent Cell-mediated Cytotoxicity (ADCC). In this process, effector cells of the immune system recognize the bound antibodies through their More

Cost and Time Effective Approach to Early Stage Biosimilar Development: A Case Study of Tocilizumab

Category: Biosimilars

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By: Dr Terry Gray, Field Marketing Manager

Introduction to Tocilizumab (Actemra) Tocilizumab (Actemra (US)/RoActemra (EU)) is a therapeutic monoclonal antibody that targets the Interleukin-6 receptor (IL-6R).  Interleukin-6 (IL-6) is a multifunctional cytokine which is central to the regulation of the immune and nervous systems.  This molecule has been linked to pathogenesis of several autoimmune diseases including rheumatoid arthritis (RA) due to aberrations More

Psoriatic Arthritis treatment attracts attention for Biosimilar development

2nd February 2015

Category: Biosimilars

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By: Dr Daniel Galbraith, CSO

Like waiting for a bus, there was no effective treatment for psoriatic arthritis then three came along. The literature has been awash with the new treatments; anti-TNF α drugs such as Enbrel and Humira. Janssens anti-IL-12/23 drug Stelara and now the new IL-17 blocker Secukinumab from Novartis. These drugs have clinically demonstrated to be effective More

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