biosimilars

Developing Biologics Faster

For centuries Scotland has been a leader in biotechnology with brewing and distilling technologies creating whiskies that are the envy of the world. So it shouldn’t come as a surprise that it is also a major player in modern biotechnology, too; with over 600 life sciences organizations, employing more than 30,000 people. That makes Scotland one of the largest life sciences clusters in Europe. A wealth of talent has been supplemented by heavy investment from biopharmaceutical companies and contract research organizations. It is fast becoming a key destination for many would-be drug developers.

This is evident at places like BioOutsource (full name – Sartorius Stedim BioOutsource Ltd.) in Glasgow, Scotland. BioOutsource is an industry leader in the characterization and comparability of biosimilar to originator biologics, providing comprehensive testing services to the biopharmaceutical industry. They have created a niche within the industry, dedicated to rapid and confident biological and structural evaluation of biosimilar monoclonal antibodies (mAbs) and vaccines. Fast off-the-shelf drug development, in the heart of Scotland. Offering a comprehensive range of physicochemical and biological testing to support biosimilar development, BioOutsource works with over a dozen biosimilar molecules and around forty biosimilar developers.

A few weeks ago I was privileged to drive through Glasgow and meet the team at BioOutsource. A highly skilled and educated group of scientists, which has grown in number several fold in the last two years as the demand for testing and development of biosimilar drugs has risen exponentially. A key mantra that drives productivity at BioOutsource is their ability to offer clients cost-effective ‘Speed to Market’, enabled through a comprehensive range of cutting edge, off-the-shelf assays for biosimilar characterization and comparability.

This strategy is clearly manifested in recent investment by BioOutsource of an innovative, fast and robust charge variant workflow. The Charge Variant Workflow comprises:

  • Thermo Scientific™ CX-1 pH Gradient Buffer Kits
  • Thermo Scientific™ MAbPac™ SCX-10 columns
  • Thermo Scientific™ Vanquish™ Flex UHPLC systems
  • Thermo Scientific™ Chromeleon™ CDS software

 


“The CX-1 pH Buffer Kits are really popular with the team in the lab because they are easy to prepare. In a few minutes you are ready to go. Plus we have full traceability from the certified kits.”

Dr. Martin De Cecco, Biochemistry R&D, Sartorius Stedim BioOutsource


Charge variants can occur in therapeutic protein products for a number of reasons, including sequence variation, post-translational modification and chemical degradation; for example asparagine and/or glutamine deamidation or C-terminal lysine truncation. Depending on the nature of the modification, the resultant species can be more acidic or more basic than the main peak. As these changes can influence the stability and biological activity of the product, the charge heterogeneity represents a challenge to demonstrating comparability.

Like what you are learning?

Sign up to stay connected with all Thermo Scientific resources, applications, blog posts and promotions.
Keep Me Informed!

For a candidate biosimilar, any differences need to be identified quickly and minimized as early as possible. This would involve further optimization of the cell culture process, or, when related to stability of the drug product, further formulation optimization.

A fast and confident charge variant profiling routine can significantly accelerate candidate development time.

The workflow has enabled BioOutsource to qualify and achieve productivity within a very short time frame. Moreover, they are able to achieve their exacting strategy of providing fast, confident protein characterization services to their clients.


The system was installed and qualified in three days, we had training and we were ready to run samples within a week.

Dr. Martin De Cecco, Biochemistry R&D, Sartorius Stedim BioOutsource


 

Watch BioOutSource’s story here:

 

For more information on the Charge Variant Workflow, please visit www.thermofisher.com/ChargeVariants