So far this year, the U.S. general economic picture has been positive, with new tax cuts, a stock market— although wobbly—that has climbed to record levels, and consumers reportedly feeling confident that everything is headed in the right direction. For the pharmaceutical sector, however, that
general economic euphoria may be somewhat
tempered by critical changes and issues that must be
dealt with by all sides of the market:
• Pressure increasing to lower drug prices
• Expensive R&D efforts challenged by cost-
• Generic drugs stealing market share from Big
• The opioid epidemic and resulting lawsuits
• Ongoing efforts to thwart counterfeit drugs from
entering the pipeline
• DSCSA serialization deadlines near and
regulatory enforcement looms
• Data security concerns
• Staying ahead of the ever-changing regulatory
The good news is that despite all of the
challenges facing the pharmaceutical sector, there
is no shortage of expert advice and proven success
strategies. This issue of Pharmaceutical Processing
examines several of those topics.
Our cover story by Jürgen Metzger of Bosch
Packaging Systems focuses on contamination control
and solutions for transferring
products into barrier systems.
In his article, Metzger
warns that a large number
of considerations must be
addressed when planning aseptic
production in order to avoid
discovering shortcomings at a
very late planning stage, or worse, during actual
Other timely topics in our March issue examine
robotics and automation in pharma R&D; how
choosing the right strategy for implementing
compressed air technology can save big money;
Multiple Attribute Monitoring in drug development;
the latest word on DSCSA; and a one-on-one
interview with Master Control’s Matt Lowe on the
effectiveness of newly introduced e-management and
Meanwhile, professionals attending INTERPHEX
2018, April 17-19, at the Javits Center in New York
will have a unique opportunity to access plenty of
information, equipment, and recommendations for
solving the pharma challenges faced now and over
the next several years.
I’ll be there too, along with our new
Pharmaceutical Processing Associate Editor Catherine
Sbeglia. We look forward to seeing you at the show!
— Mike Botta
Follow Pharmaceutical Processing Online!
Pharmaceutical Processing® (ISSN #1049-9156, USPS #001-314), is published seven times a
year. Bi-monthly in Jan/Feb, Apr/May, Jul/Aug, Sep/Oct, Nov/Dec monthly in Mar & Jun by Advantage
Business Media, 100 Enterprise Drive, Suite 600, Rockaway, NJ 07866. No part of this publication
may be reproduced in any form without prior written permission of the publisher. Opinions expressed in
articles are those of the authors and do not necessarily reflect those of Advantage Business Media.
Periodicals Mail postage paid at Rockaway, NJ 07866 and at additional mailing offices.
POSTMASTER: Send address changes/cancellations to Pharmaceutical Processing, 100 Enterprise
Drive, Suite 600, Rockaway, NJ 07866-0912, email: ABM_return@advantagemedia.com. Publications
Mail Agreement No. 41336030. Return undeliverable Canadian addresses to: Imex/Pitney Bowes, P.O.
Box 1632, Windsor Ontario N9A 7C9.
Subscriptions are free to qualified individuals.
Printed in USA: Every attempt is made to ensure the accuracy of the information contained herein,
however Advantage Business Media and its employees cannot accept responsibility for the correctness
of information supplied, advertisements, or opinions expressed. Copyright ©2018 Advantage Business
Media. All rights reserved.
Michael J. Beier,
Senior Vice President of Operations
TITAN PHARMACEUTICALS, INC.
Dr. James V. Blackwell, PhD, Consultant
BIOPROCESS TECHNOLOGY CONSULTANTS,
Ronald C. Branning,
Vice President Global Quality
Robert F. Dream, Vice President
H.D.R. COMPANY LTD.
Johanna Carmel Egan,
VGP Project Management
Girish Malhotra, President
Allan F. Pfitzenmaier, President
VECTECH PHARMA CONSULTANTS INC.
Susan Polizzotto, Manager,
R&D QA GMP Compliance
US SANOFI PASTEUR
Sr. Dir. Global Engineering
Richard G. Whitfield, Senior Director
Patrick Wong, Director of Global Engineering
BRISTOL-MYERS SQUIBB (BMS)
For subscription related matters please
contact us at: