spacer
home > pmps > summer 2009 > biomolecule formulation
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Biomolecule Formulation

The development of injectable biopharmaceutical products is based on the ability of the formulation expert to overcome three main technical hurdles. First, he must preserve the activity of the native molecule, without damaging it or changing the active structure. Secondly, he must conserve or improve the bioavailability of the molecule in order to determine a targeted therapeutic activity. Finally, he has to ensure an acceptable product expiry date while considering the volunteer recruitment programme of the clinical study and he must adjust storage conditions which facilitate the distribution of the products and their convenient medical use.

The biomolecules which are currently encountered range from high molecular weight proteins and peptides to DNA and siRNA. Most of these molecules present physico-chemical properties which do not allow the formulation of stable liquid forms. Furthermore, storage at -20 or -80°C is often required, which induces a restrictive organisation and logistics throughout the manufacturing and distribution of clinical trial material. This article will focus on the strategy required for the development of such biotech products, and on the main critical product and process variables involved in the stabilisation of biomolecules and parenteral drug products in particular.


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
Maxime Laugier is a pharmacist and graduate of the Institute of Industrial Pharmacy of Bordeaux. He has over 12 years of experience in pharmaceutical development, investigational medicinal products and manufacturing and industrial scaling up with European CMOs such as SkyePharma and Creapharm. Maxime joined MP5 in early 2007 as the Pharmaceutical Development and Projects Director.
spacer
Maxime Laugier
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Avacta develops SARS-COV-2 neutralising Affimer reagents with therapeutic potential for COVID-19

Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, is pleased to announce that several of the Affimer reagents recently generated for development of a point-of-care COVID-19 antigen saliva test have now also been shown to block the interaction between the virus’ spike protein and ACE2, a receptor on human cells that is key to the virus infection pathway1.
More info >>

White Papers

The Power of Execution in Clinical Research

Medpace

Medpace, long known for its excellence in conducting Phase I-IV studies on a global platform, is particularly noted for its therapeutic excellence. When that expertise is combined with operational precision, the results are nothing short of stellar. The Medpace full-service outsourcing approach – combined with therapeutic expertise, regulatory know how, and global presence – delivers clinical studies with an industry recognized track record.
More info >>

 
Industry Events

World Vaccine Congress Washington

27-29 September 2020, Walter E Washington Convention Center, Washington, US

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement