Channels

 

Special Offers & Promotions

 

 

Latest News

 

 

View Channel

New Products

 

 

View Channel

Video Presentations

 

 

View Channel

Separation Science

 

 

View Channel

Microscopy & Image Analysis

 

 

View Channel

Laboratory Automation & IT Solutions

 

 

View Channel

 

Sartorius Stedim Biotech Offers Services for Characterization of New Biological Entities (NBE)

publication date: Feb 18, 2019
 | 
author/source: Sartorius Stedim Biotech

Sartorius Stedim BioOutsource’s testing servicesSartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, announced the launch of services for new biological entities, called NBE Product Characterization.

These services are offered by its subsidiary, Sartorius Stedim BioOutsource, an experienced, industry-leading contract testing organization based in Glasgow, UK, and in Cambridge, Massachusetts, USA.

Sartorius Stedim BioOutsource provides a comprehensive range of testing for innovator molecules available either as off-the-shelf assays or custom assay development for more complex proteins. Such tests include cell-based potency assays, bioassays and binding assays, as well as physicochemical and structural analyses, enabling customers to benefit from a fully integrated package. These testing services are fully customizable for clients to ensure their innovator drugs are tested based on the right regulatory requirements by expert scientists. Robust data packages proving the safety, purity and potency as required by the regulatory authorities will smooth the submissions process for approval by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

As a result of these fully customizable methods and data packages available for monoclonal antibody characterization that complement BioOutsource’s and Sartorius Stedim Cellca’s existing innovative offer for biologics, pharmaceutical companies can now work with one contract partner from cell line development to qualification and validation of analytical and biological product characterization assays.

“We are really excited to bring to market this combined package of assay development and customizable off-the-shelf solutions for product characterization. With our unrivalled experience in biosimilars testing, combined with our proven expertise in NBE assay development, we have developed a panel of assays suitable for mAb characterization. This allows drug developers to fast-track complex bioassay development using our platform methods. With fully compliant cGMP facilities, we support our customers from early phase development to late phase and commercial release,” commented Jennifer Lawson, Product Manager for Testing at Sartorius Stedim BioOutsource.

 

find out more

more news from sartorius stedim



If you have not logged into the website then please enter your details below.



 

Subscribe to any of our newsletters for the latest on new laboratory products, industry news, case studies and much more!

Newsletters from Lab Bulletin

 

Request your free copies HERE

 

 

 

Popular this Month

Top 10 most popular articles this month

 

 

Today's Picks

 


 

Looking for a Supplier?

Search by company or by product

 


Company Name:

Product:


 

 

 

 

Please note Lab Bulletin does not sell, supply any of the products featured on this website. If you have an enquiry, please use the contact form below the article or company profile and we will send your request to the supplier so that they can contact you directly.

Lab Bulletin is published by newleaf marketing communications ltd.


 

Media Partners

 

Exhibitions & Events