spacer
home > ebr > summer 2017 > complex characters
PUBLICATIONS
European Biopharmaceutical Review

Complex Characters

Oligonucleotides are biopolymers consisting of modified ribonucleotide or deoxynucleotide monomer units. Since they play such a critical role at the human cellular level, they are being developed by several biopharmaceutical organisations as potential therapies and vaccines and are considered to be their own unique modality, distinct from traditional small molecule drugs and biologics.

The FDA has approved a number of these biopolymers, including fomivirsen, pegaptanib and mipomersen, primarily antisense oligonucleotides (ASOs), with several more on the way. In Europe, the Committee for Medicinal Products for Human Use, a division of the EMA, has recently recommended nusinersen for approval. n 100 oligonucleotide drugs progressing through the development pipeline, designed to target diseases and rare genetic disorders, including Huntington’s disease, asthma and certain types of cancer, as well as vaccines for the Ebola, Zika and influenza viruses.

Brief Background

Messenger RNA (mRNA) is a type of oligonucleotide that is critical to the translation of genetic sequence information of DNA into the specific amino acid array of proteins manufactured in the ribosomes of a cell’s cytoplasm. In eukaryote human cells, mRNA consists of several distinct regions. This naturally occurring sequence is known as the sense sequence.

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
Jon S Kauffman, PhD, is Senior Director of Biopharmaceutical Services and Method Development and Validation at Eurofins Lancaster Laboratories. With more than 25 years of analytical testing experience, he oversees departments responsible for developing and validating methods and performing analysis of clinical and commercial samples for stability and release purposes. Jon earned a doctorate in chemistry from the University of Delaware, US.
spacer
Jon S Kauffman
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

WuXi STA and Dizal Pharmaceutical Sign CMC Development and Manufacturing Agreement

STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – and Dizal Pharmaceutical, a biotechnology company, announce a strategic partnership. Under the terms of the collaboration, WuXi STA will become the preferred CDMO partner of Dizal Pharmaceutical for GMP production, providing integrated CMC (Chemical, manufacturing and Control) process research and manufacturing services from API to drug product.
More info >>

White Papers

The Role of the CRO in Effective Risk-Based Monitoring

Medpace

The clinical trial industry is evolving. In an effort to improve participant safety and data integrity, regulators are encouraging trial sponsors to transition from a focused on-site monitoring approach they have traditionally employed toward a risk-based approach that utilizes a combination of centralized and on-site monitoring techniques to ensure patient safety and data quality. The Risk-Based Monitoring (RBM) paradigm has many potential advantages over established monitoring practices including enhanced patient safety and data integrity, more efficient and effective protocol design, reduced costs, and the ability to strategically adjust oversight in keeping with changes in risk level.
More info >>

 
Industry Events

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from India's pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement