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08.31.21 -- Does A Mature QMS = Fewer Drug Supply Chain Disruptions?

08.31.21 -- Does A Mature QMS = Fewer Drug Supply Chain Disruptions?
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03.09.21 -- Incorporating Excipients Into QbD Studies For Drug Development -- An Introduction


03.09.21 Incorporating Excipients Into QbD Studies For Drug Development An Introduction
 
 
Orphan drugs are notorious for their high costs and risk factors, which are attributed to smaller patient pools and higher development and launch costs.
 
Attend this webinar to learn more about key trends that are causing the rise of orphan drug indications, fast-tracking early development phases that will lead to commercial success, and more!
 
 
By Brian Carlin (DFE Pharma), Chris Moreton (FinnBrit Consulting), Dave Schoneker (Black Diamond Consulting), Katherine Ulman (KLU Consulting), and Joseph Zeleznik (IMCD)
This article is the first in a three-part series based on information from the new guide, “Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design,” published by the International Pharmaceutical Excipients Council Federation. Topics covered include measuring the ....

Jens Christoph Matuszczyk , Pim Hermans , Elina Klijs , Alex Armengol , Kevin Sleijpen , James Faust , Anja Overweel , Melisa Carpio , Robert Smith , Gerhard Greller , Frank Detmers , Janice Abel , Brian Rodenhausen , Sebastian Ruhl , Andy Goll , Jens Rupprecht , Hendrik Adams , Matt Hicks , Maria Lloris , Bernat Busquet , Paul Janszen , John Erdner , Simon Adema , Frederic Baudry , Seeq Corporation , Article Stevanato Group ,

01.07.21 -- Facility Engineering, Design, And Construction Tips For Up-Start Biotech Companies


01.07.21 Facility Engineering, Design, And Construction Tips For Up-Start Biotech Companies
 
 
This report helps small and emerging biopharma companies make more informed CMO decisions, and helps CMOs optimize operational and marketing strategies to better accommodate this segment. Findings are based on 93 service encounters from 42 respondents involved in outsourced small molecule API projects in the past 18 months. Learn more here.
Featured Editorial
By Herman F. Bozenhardt and Erich H. Bozenhardt
Fledgling biotech companies are financially fragile, and they can ultimately become controlled by demanding fund managers. Those who manage facility engineering, design, and construction for these companies must adjust their thinking and employ some new tactics to document all costs and impacts, reduce schedules, and maintain quality. ....

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