samedan logo

 
 
spacer
home > white papers > Optimize your Biologicís Analytical Program for Greater Risk Reduction - Merck
WHITE PAPERS
logo_Merck.jpg

Merck

phone +33 (0)5 57 960 960
email Sebastien.ribault@merckgroup.com
web http://www.merckmillipore.com/adaptive-CDMO
email 1 rue Jacques Monod, Site Montesquieu, 33650 Martillac, France

Optimize your Biologicís Analytical Program for Greater Risk Reduction

Analytical methods are used throughout upstream and downstream processes to help ensure the desired molecule is being produced with the desired purity. In addition to having the right molecule, quality must be confirmed in terms of glycosylation, oxidation, aggregates, activity and concentration. The analytical package must also ensure that all impurities from the manufacturing process and environment are consistently removed.
Optimize your Biologicís Analytical Program for Greater Risk Reduction
spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

3P innovation Announces Transition to Employee Ownership

Award-winning, UK based engineering and process automation company, 3P innovation Ltd, is proud to announce that it is now an employee-owned company. This transition has been taken to secure its long-term future, for the benefit of customers and employees alike.
More info >>


White Papers

EU GDP Guidelines: Implications for Shipping Clinical Materials into the European Market

PCI Pharma Services

Recently, the UKís Medicines and Healthcare products Regulatory Agency (MHRA) opened an investigation into a patient complaint of mold on paracetamol (acetaminophen) tablets (1). It discovered the product was shipped by sea from India to multiple companies in the UK at temperatures reaching up to 60 degrees Celsius. Labeling for paracetamol tablets typically states they should be kept below 30 degrees Celsius. In addition, MHRA discovered the humidity levels exceeded 80 percent during shipping, which is too high for the packaging that was used.
More info >>


Industry Events

DIA Europe 2021

15-19 March 2021, VIRTUAL CONFERENCE

DIA Europe is the must-attend event for all life science professionals working in drug development, from discovery to marketed use. It encourages open collaboration by bringing together representatives from the entire spectrum of the life science landscape and facilitating crucial discussions across several topic tracks: Clinical Development, Regulatory Strategy, Pharmacovigilance, Value and Access, Health Policy, and many more.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement