Pharmaceutical Manufacturing Preview

May 2016 Preview

Ad Closing: April 15, 2016 | Material Closing: April 22, 2016

Covery Story
Branded Pharma Trends
There is no shortage of challenges facing today's branded pharma products. Patent expirations, generic competition, drug pricing battles, and the hunt for innovation gaps for new products are familiar struggles for branded pharma. Editor Karen Langhauser explores specific branded pharma strategies used to retain market share when generics come into play. The discussion includes trends such as:

Operations
Biomagnetic Separation, Thinking Bigger Part II
When it comes to the practical application of biomagnetic protein purification, there are limitations due to its lack of efficiency at large volumes. Part II of a piece published by Pharmaceutical Manufacturing last year, this article from Lluis M. Martinez of SEPMAG explores how biomagnetic protein purification can be easily implemented at large volumes if the separation process is correctly defined at early stages.

Tech at Work
GlaxoSmithKline Banks on Vision System Flexibility
The multinational pharmaceutical giant wanted to continue inspecting its products itself at its Evreux, France production facility. They were looking for a vision system that did not require any direct operator intervention and thus would eliminate the risk of incorrect adjustments. This piece will discuss why they chose to add the Keyence XG vision system to their automated process control system.

McKinsey on Operations Excellence
Replicating Success: Scaling up quality transformation across a network
McKinsey analysts Sasikanth Dola, Jean-Baptise Pelletier, Lorenzo Positano and Paul Rutten contend that quality transformations can have tremendous impact reducing quality incidents by 30-50%. Transformation in a small pilot area is often successful, but many pharmacos struggle to replicate this success throughout a network. This article will discuss the best replication mechanisms.

Quality & Compliance
Meeting Looming DSCSA Deadlines
In accordance with the Drug Supply Chain Security Act, complex serialization milestones loom for the pharma industry -- the next one being November 2017. The Electronic Product Code Information System (EPCIS) is one of the top contenders for serialized data exchange. What is EPCIS, what are the key considerations and timing, and how can you best prepare while you await the decision? GS1, a non-for-profit organization facilitating healthcare industry and FDA collaboration to adopt and use standards to support DSCSA requirements, will discuss DSCSA, EPCIS and how the industry needs to exchange information at the individual package level.

Informatics and Data Management
PLM for Pharma -- Applying an Old Tool in New Ways
Pharma companies employ different models to succeed in this demanding new environment. One common challenge across these models - discovery, development and launch of new products - is management of product and process data. As companies "lean out" and speed up their development processes with new technologies, they face increasing challenges with capturing and efficiently managing data as it flows from their labs to their plants around the globe. Experts at PwC will discuss how pharma companies are beginning to tap into the capabilities of Product Lifecycle Management processes and tools in order to address this product and process data challenge.

Automation and Control
Specifying Instruments to Meet Pharmaceutical Hygienic Requirements
Pharmaceutical manufacturing applications call for a variety of process instruments to meet the demanding requirements of this highly regulated industry. Users often place their highest emphasis on the configuration of instruments since these are spelled out in detail in the various standards and manufacturing practices. Ron Pozarski, senior industry manager with Emerson Process Management and Emily Saopraseuth of Rosemount Pressure discuss why it is just as important to pay attention to the instrument sensor itself and the instrument transmitter electronics supporting it.

Supply Chain Excellence
Audit & Inspection Dos and Don'ts
This topic will be explored from two different perspectives:

MasterControl supply chain expert Terrance Holbrook explores and provides guidance on the challenges that pharmaceutical manufacturers face when their suppliers' quality systems perform poorly. The piece addresses common risks of poor supplier quality, how to tell if a supplier's quality system is failing, and how to guide a supplier to a state of quality.

CDMOs that are routinely successful in regulatory inspections are aware of the pitfalls and obstacles and incorporate a plan for compliance into their company culture. In this piece, Joachim del Boca, Vice President of Regulatory Affairs/Quality Compliance for Vetter, shares some key considerations from a CDMO perspective how to successfully manage a regulatory inspection.

Innovators/Product Focus
Fill & Finish; Drug Delivery Devices
Product round-up from prominent equipment and technology suppliers.


Advertising & Editorial Information

For advertising information contact your district manager or Mark Wiebusch, Publisher, at 630/467-1300 ext. 393, mwiebusch@putman.net. Send insertion orders to Rita Fitzgerald, Production Manager, rfitzgerald@putman.net at Pharmaceutical Manufacturing, 1501 E. Woodfield Rd., Suite 400N, Schaumburg, IL 60173; fax 630/467-1120.

For editorial information, contact Karen Langhauser, Editor-in-Chief, at 630/467-1301, Ext. 463, klanghauser@putman.net.

Pharmaceutical Manufacturing