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)
08 CMOs: Strategic Initiatives for Growth
in a Crowded but Burgeoning Field
Leveraging tech transfer and analytical
capabilities to enter new markets and absorbing
additional production steps that brand owners
are seeking to offload.
12 Deadlines Loom in the March to
Become Fully Compliant
The tracking systems resulting from DSCSA will
complement the drug design control process,
which includes guidelines that companies must
follow in order to enter ingredients into the
16 Scottish Specialty CMO
Thrives as ‘One-Stop-Shop’
Becomes the Trend
CMO Symbiosis Pharmaceutical Services, a
small-scale, niche sterile manufacturer, finds
market sweet spot in the development and
manufacturing of biologics, highly potent APIs,
and small molecules.
20 Biosimilars May Be Similar, but Their
Barriers to Entry Are Unique
Despite immense challenges and hurdles,
biosimilars may be where generic medicines
were in the mid-1980s.
24 Pinpointing Opportunities in Generics
India-based Dr. Reddy's expects the bulk of
short-term market growth to be in complex
generics, while mid- to long-term likely will shift
6-7 What’s Hot in Innovation
26 What’s Trending on PharmPro.com
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, 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
(c)2017 Advantage Business Media. All rights reserved.