samedan logo
 
 
 
spacer
home > ebr > summer 2008 > protein potential
PUBLICATIONS
European Biopharmaceutical Review

Protein Potential

Interferon alpha (IFNα) was one of the first FDA-approved biotherapeutic treatments. Since its approval, it has proved to be a powerful cytokine with potent therapeutic activity but, unfortunately, strong side effects. The overall use of IFNα increased dramatically when it was approved as the treatment of choice for hepatitis C.

However, nearly half of the individuals infected with genotype 1 of the virus still fail to respond to therapy (1). Consequently, several pharmaceutical companies are now trying to turn on the body’s own interferon alpha family of proteins using immunomodulatory molecules in the hope that this will elicit a more complete antiviral response. Both therapeutic approaches are not without risk, due to the side effects associated with IFNα. Additionally, there is a growing amount of published scientific articles suggesting that IFNα may be involved in certain autoimmune diseases, including systemic lupus erythematosus (SLE) (2).

Combined, these observations clearly suggest an increased need to monitor IFNα levels in both normal and diseased individuals along with patients undergoing therapy. How much IFNα produced by the body in response to new immunomodulatory therapies will be functionally equivalent to the current IFNα exogenous treatment regimen? How much ‘basal’ IFNα is beneficial to prevent or limit viral infection and how much is too much, thereby predisposing an individual to autoimmune disorders?


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.

 You must be a member of the site to make a comment.
spacer
Ronald G Jubin PhD is the current Research and Development Director at PBL InterferonSource. Previously, he was a Research Scientist with Schering-Plough from 1992 to 2004 in the antiviral therapy department, working on hepatitis C virus and interferon antiviral mechanisms. Whilst there, he published several papers that helped better define the mechanism of HCV translation. Ronald received his BA in Microbiology from Kean University, his MS degree in Microbiology from Seton Hall University and his PhD in Microbiology and Molecular Genetics from the University of Medicine and Dentistry of New Jersey, US.
spacer
Ronald G Jubin
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Ardena expands capacity to satisfy Novavax COVID vaccine demand

Gent, Belgium/December 2021: Ardena, a specialist pharmaceutical contract development and manufacturing organisation (CDMO), announced it will be expanding its capacity for purification and fractionation of GMP manufacturing at its site in Södertälje, Sweden. The expansion will satisfy long-term demand expected from Novavax for production of the company’s COVID-19 vaccine, among others.
More info >>

White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement