spacer
home > ebr > spring 2017 > balancing act
PUBLICATIONS
European Biopharmaceutical Review

Balancing Act

Escherichia coli has been the historical workhorse for the production of therapeutic proteins since the first biologic, insulin, hit the market in 1982. It continues to be a preferred system, because operations are inexpensive and timelines are short. Pharmaceutical companies tune the fermentation procedure for the greatest yield in every batch by maximising the cell density per batch and per cell expression. Peak cell density is obtained through process optimisation, and maximal specific productivity is achieved by strain/vector engineering.

These two activities require different research skillsets and are often performed independently of each other. Small virtual companies with preclinical programmes often separate these activities by outsourcing them to different firms. One service provider develops a strain, which is then transferred to a contract manufacturing organisation to maximise the cell density in order to enable the isolation of sufficient product to file an investigational new drug and support Phase 1 and 2 trials.

Such strategies often rely on the assumption that fine-tuning the process can occur during early clinical development. The downfall, however, occurs when fermentation cannot be significantly improved without genetic engineering of the strain. Creation of an entirely new master cell bank constitutes a major procedure change that means going ‘back to the drawing board’. If the end goal is to hand the therapeutic to a large pharma company in order to launch a commercial process, then this downfall can represent a considerable decrease in value.

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
April Stanley is the Manager of Cell Line and Strain Development at Cytovance, and earned her Master’s Degree from the University of Illinois, US, in Microbiology. During her six years at Cytovance, she has designed the company’s E. coli toolbox and currently leads the team that developed the platform fermentation processes, which match the production strains generated with the toolbox.
spacer
April Stanley
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Growing market for generics and liberalization of Over-The-Counter medicines driving demand at CPhI Japan 2017


More info >>

White Papers

Achieve full compliance with tamper-verification pharma solutions

UPM Raflatac

UPM Raflatac has developed a range of pharmaceutical labelling products to support compliance with the Falsified Medicines Directive on packaging for prescription drugs and high-risk, over-the-counter medicines. Few solutions offer the same ease of adoption for meeting the February 2019 deadline.
More info >>

 
Industry Events

Orphan Drugs and Rare Diseases Europe 2017

15-16 May 2017,

SMi is proud to announce the return of their 6th annual Orphan Drugs event to Berlin on the 15th -16th May 2017! The global orphan drug market totaled nearly $123 billion in 2014 and will continue to grow to reach nearly $191 billion by 2019.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement