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 recognised 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 recognise 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

Testing for Human Cytomegalovirus

5th December 2013

Category: Biosafety

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By: Dr Daniel Galbraith, CSO

Human cytomegaloviruses (and simian) are members of a virus family that are specifically identified by the biologics safety guidelines as a specific concern. Most recently the 2010 FDA guidelines for testing of vaccine cell substrate included a recommendation that if there is the possibility of contamination with Human and Simian cytomegalovirus then the in vitro More

Top 10 problems encountered in IND or BLA submissions

24th October 2013

Category: Bioanalytical / Regulatory

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By: Dr Daniel Galbraith, CSO

During the Well Characterised Biological Congress an FDA reviewer gave us an insight into some of the common problems encountered in IND or BLA submissions with a list of the Top 10 inadequacies. Number 1 – The lack of procedural details contained within the submission. What was clear was that the FDA requires a working SOP More

Prospect of plant based production methodologies for Trastuzumab (Herceptin)

8th October 2013

Category: Biosimilars

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By: Dr Daniel Galbraith, CSO

The production of Biosimilar Monoclonal Antibodies often follows the same or similar production methodologies to the innovator product, Chinese Hamster Ovary Cells being the most common method. However there is nothing in the current guidelines to prevent the use of other production systems for these products. In the paper published by Grohs et al., 2010 More

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