BioPharm
I N T E R N AT I O N A L
eBook
T h e S ci e n ce & B usi n e ss o f B i o p h a r m a ce u ti c a ls
FOUNDER
Mike Hennessy Sr
1960 - 2021
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Contents
EDITORIAL
Vice President, Content Alicia Bigica ABigica@mjhlifesciences.com
Senior Editor Felicity Thomas FThomas@mjhlifesciences.com
Lead Editor Susan Haigney SHaigney@mjhlifesciences.com
Science Editor Feliza Mirasol FMirasol@mjhlifesciences.com
Assistant Editor Daria Husni DHusni@mjhlifesciences.com
Contributing editors
Cynthia A. Challener
Design and Production
Creative Director Robert McGarr rmcgarr@mjhlifesciences.com
Senior Art Director Kristen Morabito kmorabito@mjhlifesciences.com
Print and Circulation Director Jonathan Severn jsevern@mjhassoc.com
Production Manager Charlton Prince cprince@mjhlifesciences.com
Print Production Coordinator Amber Immordino ammordino@mjhassoc.com
CUSTOM CONTENT
Director Robert Alaburda
Managing Editor Jeanne Linke Northrop
Senior Editor Megan Manzano
Senior Editor Shannon Stolz
ADVERTISING
National Sales Manager Scott Vail SVail@mjhlifesciences.com
National Account Associate Padraic Finnegan
PFinnegan@mjhlifesciences.com
European Sales Manager Linda Hewitt LHewitt@mjhlifesciences.com
European Senior Sales Executive Stephen Cleland
SCleland@mjhlifesciences.com
MJH LIFE SCIENCES
®
President & CEO Mike Hennessy Jr
Chief Financial Officer Neil Glasser, CPA/CFE
Chief Operating Officer Beth Buehler
Chief Data Officer Terric Townsend
Executive Vice President, Global Medical Affairs
& Corporate Development Joe Petroziello
Executive Vice President, Healthcare Brian Haug
Senior Vice President, Content Silas Inman
Senior Vice President, Human Resources
& Administration Shari Lundenberg
Senior Vice President, Mergers & Acquisitions,
Strategic Innovation Phil Talamo
Executive Creative Director Jeff Brown
Partnerships in Outsourcing
eBook May 2024
Cover: Andrii Yalanskyi – Stock.Adobe.com
ANALYTICS
Navigating the Preclinical
CRO Outsourcing Process
Daniel Radiloff
The need for preclinical testing expertise
is growing as molecular complexity increases. 4
MANUFACTURING
Leveraging Blow-Fill-Seal
Technology for
Biologic Delivery
Vincenza Pironti
The rising demand for biologics and technological
innovations are driving blow-fill-seal capacity, harnessing
manufacturing efficiency, and benefitting patients. 8
QUALITY
How to Evaluate a CDMO's
Commitment to Quality
Ania Szymanska
What do you need to ask during the vetting and
selection process to ensure your clinical or commercial
program won't be derailed by a quality-related problem? 12
Ensuring Quality in Contracted Support
Iain McGhee
This article looks at the relationship between
a CDMO quality organization and the client. 18
www.biopharminternational.com Partnerships for Outsourcing eBook May 2024 BioPharm International
®
3
BioVectra DCL .................................................................................. 5
Curia ................................................................................................. 2
Emergent BioSolutions ................................................................... 9
Intertek Asg (Darts) ....................................................................... 22
Sannova Analytical Inc. ................................................................ 13
Simtra BioPharma Solutions ........................................................ 15
Ad Index
COMPANY PAGE
