2 BioPharm International eBook Partnerships for Outsourcing eBook May 2023 www.biopharminternational.com
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 t i c a ls
Contents
Cover: Koto Amatsukami - Stock.adobe.com
INDUSTRY TRENDS
Identifying Outsourcing Market Trends
Grant Playter 4
EARLY DEVELOPMENT
CROs Gaining a Competitive Edge
Felicity Thomas 8
PROCESS DEVELOPMENT
Streamlining and Standardizing
Process Characterization
Claudia Berdugo-Davis and Danielle Wittenwyler 12
MANUFACTURING
Scaling Manufacturing Processes
Using Single-Use Technologies
Kai Lipinski 18
FILL/FINISH
Fill/Finish Lessons
Learned from COVID-19
Roberto Raffaele Addamo 24
Preparing for a
New Wave of mRNA Technologies
Jeong Jin-hyeok 28
TECH TRANSFER
Communication is Key
in Complex Tech Transfer
Susan Haigney 32
AD INDEX 37
Partnerships for
Outsourcing 2023
FOUNDER
Mike Hennessy Sr
1960 - 2021
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ADVERTISING
Executive Vice President, HealthcareBrian Haug BHaug@mmhgroup.com
Vice President, Pharmaceutical Sciences Todd Baker TBaker@mjhlifesciences.com
Publisher Mike Tracey MTracey@mjhlifesciences.com
National Sales Manager Scott Vail SVail@mjhlifesciences.com
European Sales Manager Linda Hewitt LHewitt@mjhlifesciences.com
European Senior Sales Executive Stephen Cleland SCleland@mjhlifesciences.com
AUDIENCE DEVELOPMENT
Audience Development Stacy Argondizzo SArgondizzo@mjhlifesciences.com
MJH LIFE SCIENCES
TM
President & CEO Mike Hennessy Jr
Chief Financial Officer Neil Glasser, CPA/CFE
Chief Marketing Officer Brett Melillo
Chief Data Officer Terric Townsend
Executive Vice President,
Global Medical Affairs & Corporate Development Joe Petroziello
Senior Vice President, Content Silas Inman
Vice President, Human Resources and Administration Shari Lundenberg
Vice President, Mergers & Acquisitions Phil Talamo
Executive Creative Director Jeff Brown
EDITORIAL
Editorial Director Chris Spivey CSpivey@mjhlifesciences.com
Senior Editor Felicity Thomas FThomas@mjhlifesciences.com
Managing Editor Susan Haigney SHaigney@mjhlifesciences.com
Science Editor Feliza Mirasol FMirasol@mjhlifesciences.com
Editor Jill Murphy JMurphy@mjhlifesciencs.com
Associate Editor Grant Playter GPlayter@mjhlifesciences.com
Assistant Editor Alivia Leon ALeon@mjhlifesciences.com
Creative Director, Publishing Melissa Feinen
Senior Art Director Marie Maresco; Senior Graphic Designer Maria Xelo
CONTRIBUTING EDITORS:
Jill Wechsler jillwechsler7@gmail.com; Hallie Forcinio, editorhal@cs.com;
Susan J. Schniepp, sue.schniepp@mac.com; Cynthia A. Challener, PhD
challener@vtlink.net; and Jennifer Markarian, Manufacturing Reporter.
CUSTOM CONTENT:
Vice President, Content and Special Projects Colleen Hall;
Director Robert Alaburda; Managing Editor Jeanne Linke Northrop;
Senior Editor Megan Manzano; Senior Editor Shannon Stolz; Senior Writer Zainab Khan
