Newsletter | January 26, 2023

01.26.23 -- Make The Service Agreement Work For You And Your CDMO
 
Featured Editorial
Make The Service Agreement Work For You And Your CDMO
 
By Mauro Turrini, Jean-Christophe Troussel, Nadia Feola, and Auriane Schockaert

Knowledge of the applicable rules and legal challenges, as well as ways to ensure the enforcement of proprietary rights, requires companies to invest in negotiating and drafting robust and balanced CDMO service agreements. This article provides practical tips (for both the principal and the CDMO) for drafting these vital legal agreements.
Cleanroom Gowning Programs Compliant With EU GMP Annex 1
 
By Crystal M. Booth, PSC Biotech

Part 1 of this article series provided an overview of cleanroom gowning per the revised EU GMP Annex 1. This article focuses on establishing an aseptic personnel gowning program compliant with the Annex.
Industry Insights
Starting Your Sterile Injectables Program Off On The Right Foot
Article | By Jennifer Quint and Daniel Lenz, Pfizer CentreOne

How can drug sponsors and developers leverage these increasingly strategic commercial fill/finish partnerships? Explore tips on how to put programs on a firmer footing.
Does Selecting A CDMO Based On Price Really Save You Money?
Article | Pfizer CentreOne

Before you sign on the dotted line, do a little digging to unearth potential costs that could turn your development program into a cash-burning exercise.
Learn About Affinity Chromatography Using Tagged Protein Purification
e-book | Cytiva

Choosing the right tag is essential to getting the purity, solubility, and protein quality your application needs. Learn how to prepare a recombinant protein in the quantity and quality you need.
Improve The Injection Experience In Chronic Care
Q&A | BD Medical - Pharmaceutical Systems

This series of frequently asked questions covers the research and design mindset applied to the development of the BD Neopak XtraFlow solution and how the anticipated clinical benefits of 8 mm needles will support their broad adoption over time for subcutaneous drug delivery, particularly for use in chronic care settings.
News Headlines
Solutions
Minimizing Uncertainty Throughout The Development Life Cycle
West Pharmaceutical Services, Inc.
Large Molecule Biologics Made With Intelligent Collaboration
Pfizer CentreOne
Powerful. Possible. Compliant. Discover Our NGS Services
MilliporeSigma Biosafety Testing Services
Life Science Leader Magazine
 

Have you heard of Life Science Leader?
Check it out today for access to candid interviews with top-tier executives on how they do business.