samedan logo
 
 
spacer
home > white papers > Planning the Execution of a Viral Clearance Study - Eurofins BioPharma Product Testing
WHITE PAPERS
logo_Eurofins.jpg

Eurofins BioPharma Product Testing

phone +32 2 766 16 20
email pharma@eurofins.com
web http://www.eurofins.com/Biopharma
email Chaussée de Malines, 455 B-1950 Kraainem

Planning the Execution of a Viral Clearance Study

Viral clearance studies are a necessary component of any regulatory submission for clinical trials or commercial product approval for all biopharmaceutical products. These studies are performed to evaluate the capability of the purification process to remove or inactivate viruses that could potentially contaminate the starting material. They are complex studies that require substantial financial and personnel resources, as well as specialized scientific expertise to perform. As such, viral clearance studies are often performed at a qualified contract testing laboratory rather than in-house. When multiple parties are involved in this process, clear communication and a comprehensive understanding of the approach and timeline is critical.
spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

2019 Pharmapack Awards

Pharmapack Europe have announced entries for the 2019 Pharmapack Awards are now open across both the ‘Exhibitor Innovation’ and ‘Health Products’ categories with a closing date of 30th November 2018. The Health Products category will include two winners with one for Patient-Centric Design – which is launched in partnership with HCPC Europe (Healthcare Compliance Packaging Council of Europe) – and a second introduced alongside Adelphe for Eco-design in health packaging and drug delivery devices. Pharmapack Europe have also announced that they’re accepting applications for the start-up hub which provides young start-up companies servicing the pharma industry with the benefit of valuable networking and learning opportunities at half the price of a regular stand.
More info >>


White Papers

Orthogonal Approaches for the Analysis of Protein Sequence and Post Translational Modifications of a Monoclonal Antibody

RSSL

Monoclonal antibodies are an important class of biopharmaceuticals. They are expressed from living cells and therefore, are subject to complex biochemical pathways. Not all of these pathways are fully understood and many are known to be sensitive to subtle environmental changes during production. These changes may affect the final biopharmaceutical sequence, structure and post-translational modifications. This is in addition to any changes that may occur during subsequent purification. This means that the final product from one batch may be subtly different from another batch. Furthermore, each batch is a heterogeneous mix of similar molecules. Analysis of the degree of batch-tobatch variation, and batch heterogeneity, is therefore, very important to establish in order to be confident that the drug is safe and effective for medicinal use.
More info >>


Industry Events

INTERPHEX 2019

2-4 April 2019, Javits Center, New York

At INTERPHEX, find all of the State-of-the-Art Solutions you need to Cost Effectively Develop and Manufacture Product. INTERPHEX is a premier pharmaceutical, biotechnology, and medical device development and manufacturing event and sponsored by Parenteral Drug Association (PDA). Dedicated to Innovation, Technologies and Knowledge, the show focuses on the entire product development life cycle.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement