spacer
home > ebr > autumn 2017 > definitive screening designs
PUBLICATIONS
European Biopharmaceutical Review

Definitive Screening Designs

The ability to quickly develop reliable and robust analytical test methods is an important aspect of navigating the technical path to a successful investigational new drug (IND) submission. Often, an insufficient amount of time is allocated to understanding analytical methods and reference materials and how they perform at in-process test points.

Charge Heterogeneity

Analytical comprehension is particularly challenging for proteins expressed in mammalian cells, which can present extensive charge heterogeneity resulting from variations in post-translational modifications (PTMs). The milieu parameters in any given bioprocess can impact charge heterogeneity, which, when not properly understood and controlled, can cause unwanted batch-to-batch variation in product quality.

Therefore, early detection of charge heterogeneity, using a robust method with good resolution, is an important capability for process development. Some PTMs result in charge differences on the molecule that are likely to alter the protein’s stability or activity.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Dr Srividya Suryanarayana has over five years’ industry experience at Cytovance Biologics and over seven years’ academic experience in R&D. She is a subject matter expert on charge-based analytical methods using icIEF and has a strong background in enzymology, protein biochemistry, analytical method development, qualification and validation. Srividya is a method validation lead scientist in Quality Control at Cytovance Biologics, leading method validation activities for several client-specific projects. She holds a PhD in biochemistry/biophysics from the University of Kansas, US, and has completed post-doctoral training from the Medical College of Wisconsin, US.
spacer
Dr Srividya Suryanarayana
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Oxford Genetics licenses SnapFast™ expression vectors to Twist Bioscience

November 16, 2017, Oxford, England and San Francisco, US. – Oxford Genetics, a leader in innovative synthetic biology-based technologies for biologics discovery, development and delivery, announced today a new licensing agreement with Twist Bioscience Corporation, a company enabling customers to succeed through its offering of rapid, high-quality synthetic DNA. Oxford Genetics will supply Twist Bioscience with its SnapFast™ technology platform to provide a broad range of application-specific expression vectors which Twist Bioscience will use to clone synthesized DNA for its diverse customer base.
More info >>

White Papers

The Importance of ADCC in Assessing Clinically Relevant Differences

Sartorius Stedim BioOutsource Ltd

Biosimilars have caused a revolution in the development of biologic drugs. The model for biosimilars is a combination of speed to market and low cost; these are fundamental to any biosimilar development project. The biosimilars pathway to approval is not always without difficulty, biosimilars are still relatively new, and as each new applicant is reviewed we are learning more and more about these molecules.
More info >>

 
Industry Events

Clinical Trial Supply New England 2018

7-8 March 2018, Boston, MA, USA

Clinical Trial Supply New England has now reached its 7th birthday! For the 7th annual Clinical Trial Supply New England 2018 conference, we have speakers who will focus primarily on discussing case studies, drawing from their own experiences to share the highs and lows for you to adopt in your trials.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement