Official Media Sponsor of the INTERPHEX Show
GENERAL MANAGER, MANUFACTURING GROUP
TODD BAKER, 973-920-7118
EDITORIAL ADVISORY BOARD
Michael J. Beier,
Senior Vice President of Operations
TITAN PHARMACEUTICALS, INC.
Dr. James V. Blackwell, PhD, Consultant
BIOPROCESS TECHNOLOGY CONSULTANTS, INC.
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
Carlos Villalobos, Sr. Dir. Global Engineering
Richard G. Whitfield, Senior Director
Patrick Wong, Director of Global Engineering
BRISTOL-MYERS SQUIBB (BMS)
8 New Developments in
Cyclic olefin copolymers make strong
inroads in pharmaceutical packaging.
14 New Challenges: Social
Media Backlash and Generic
Drug Inflation Penalties
Navigating inflation penalties, public
perception, and pharmaceutical revenue
20 A CMO with a Hand
in Both the Contract
PCI Synthesis’ journey: from discovering
their niche as a company, to becoming
the largest small molecule drug
substance manufacturer in the New
26 Facing Up to the Challenge
of Low Endotoxin Recovery
Better understanding LER and how to
detect endotoxins in medicinal products.
30 Improving Operations with
A new generation of analytics software
simplifies extraction of insights and value
from data historians.
5 From the Editor
PHARMACEUTICAL PROCESSING® (ISSN #1049-9156, USPS
#001-314), is published seven times a year. Monthly except combined
in Jan/Feb, Sep/Oct, Nov/Dec, no issue in May and Aug by Advantage
Business Media, 100 Enterprise Drive, Suite 600, Box 912, Rockaway,
NJ 07866-0912. 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, P. O. Box 3574, Northbrook, IL 60065-
3574, 847-559-7560, Fax: 847-291-4816, email: firstname.lastname@example.org.
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. Non-qualified
subscription rates per year are: USA $110, Canada, Mexico & Foreign
$158, single copy USA $17.50, single copy Canada, Mexico & Foreign
$25, prepaid in USA funds drawn on a USA branch bank.
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
©2016 Advantage Business Media. All rights reserved.