2 BioPharm International
®
Manufacturing and Facilities eBook 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: onlyyouqj - stock.adobe.com
MANUFACTURING: SINGLE-USE SYSTEMS
De-Risking Sterile Manufacture with SUTs
Ben Wylie
Single-use technologies provide a barrier
between operators and drug products, allowing
for sterility and personnel safety in manufacturing. 4
MANUFACTURING: TECH TRANSFER
Tech Transfer and Regulatory Compliance
Jinhyeok Jeong and John Thomas
Demand for efficient tech transfer,
as well as compliant on-time delivery, is rising.
8
FACILITIES: OLIGONUCLEOTIDES
Oligonucleotide Production Facilities
Kyle Hubbard and Bill Jarvis
As oligo manufacturers scale up production from lab-scale to clinical
and commercial scales, they may require volumes of hazardous
materials that drive additional facilitydesign considerations. 14
FACILITIES: SUSTAINABILITY
Sustainability Using
Zero-Carbon Biopharma Facilities
Susan Haigney and Alivia Leon
How can sustainability and
zero-carbon initiatives be achieved? 22
INDUSTRY UPDATE
Update on Facilities
and Manufacturing Trends
Daria Husni
This article presents the latest developments in
biopharmaceutical manufacturing and facilities. 26
AD INDEX 28
Manufacturing
and
Facilities
2023
FOUNDER
Mike Hennessy Sr
1960 - 2021
© 2023 MultiMedia Pharma Sciences LLC All rights reserved. No part of this publication may
be reproduced or transmitted in any form or by any means, electronic or mechanical including by
photocopy, recording, or information storage and retrieval without permission in writing from the publisher.
Authorization to photocopy items for internal/educational or personal use, or the internal/educational or
personal use of specific clients is granted by MultiMedia Pharma Sciences LLC for libraries and other users
registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400
fax 978-646-8700 or visit http://www.copyright.com online. For uses beyond those listed above,
please direct your written request to BPpress@mmhgroup.com with "Permissions" in the subject line.
Reprints: Contact Brian Haug, bhaug@mmhgroup.com.
MultiMedia Pharma Sciences LLC provides certain customer contact data (such as customers'
names, addresses, phone numbers, and e-mail addresses) to third parties who wish to promote relevant
products, services, and other opportunities that may be of interest to you. If you do not want MultiMedia
Pharma Sciences LLC to make your contact information available to third parties for marketing purposes,
simply email mmhinfo@mmhgroup.com and a customer service representative will assist you in removing
your name from MultiMedia Pharma Sciences LLC lists.
BioPharm International does not verify any claims or other information appearing in any of the
advertisements contained in the publication, and cannot take responsibility for any losses or other damages
incurred by readers in reliance of such content.
BioPharm International welcomes unsolicited articles, manuscripts, photographs, illustrations, and
other materials but cannot be held responsible for their safekeeping or return.
To subscribe, email mmhinfo@mmhgroup.com
ADVERTISING
Executive Vice President, Healthcare Brian Haug BHaug@mmhgroup.com
Vice President, Pharmaceutical Sciences Todd Baker TBaker@mjhlifesciences.com
National Sales Manager Scott Vail SVail@mjhlifesciences.com
National Account Associate Andrew Demboski ADemboski@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
Assistant Editor Daria Husni DHusni@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 Editor Terri Somers
e B O O K S E R I E S
Single-Use Systems
Oligonucleotides
Tech Transfer
Industry Update
Sustainability
N O V E M B E R 2 0 2 3
MANUFACTURING
AND FACILITIES
2023
