spacer
home > white papers > Optimize your Biologic’s 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 Biologic’s 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 Biologic’s Analytical Program for Greater Risk Reduction
spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

Significant improvement in overall survival with ERLEADA®▼ (apalutamide) for patients with non-metastatic castration-resistant prostate cancer

BEERSE, BELGIUM, May 14, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the final analysis of the pivotal Phase 3 SPARTAN study demonstrating ERLEADA®▼ (apalutamide) in combination with androgen deprivation therapy (ADT) significantly improved overall survival (OS), compared to ADT alone, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high risk of developing metastases.1 Results will be presented at the American Society of Clinical Oncology (ASCO) Virtual Scientific Programme (Abstract #5516) beginning on Friday 29th May.
More info >>


White Papers

Backward Thinking

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market.
More info >>


Industry Events

12th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology

8-11 February 2021, Vienna, Austria

In continuation of the very successful scientific meetings in Budapest, Paris, Berlin, Florence, Geneva, Barcelona, Malta, Istanbul, Lisbon, Glasgow and Granada, the 12th PBP World will be held in Vienna from 8-11 Feb 2021. This every two year held conference has gained an ever increasing impact among the pharmaceutical scientists: With up to 1000 submitted abstracts and about 1300 participants it has become a well-established major meeting, attracting scientists from all over the world.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement