Pharmaceutical Manufacturing Preview

June 2015 Issue Preview

Ad Closing: May 15, 2015 | Material Closing: May 22, 2015

BioManufacturing Trends
Time for a New Prescription
McKinsey Group authors Ralf Otto, David Keeling, Akira Sugahara note that biopharma has attracted plenty of new players in recent years, but for most of them, the experience has been an uphill struggle. Newcomers have learned the hard way that biopharma operations are vastly more complex than traditional operations, requiring entirely new levels of technical and management sophistication. McKinsey's analysts offer insight into how companies can master these challenges and win.

Critical Trends Driving BioProduction Strategies
According to Eric S Langer and BioPlan Associates, the biopharmaceutical manufacturing industry has undergone many changes over the past decade, ranging from better expression systems to new modular and flexible facilities and the emergence of single-use devices. Each of these trends is being driven by the need for productivity and efficiency and BioPlan takes a deep dive into this segment of the Pharma industry illuminating data from its most recent 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.

Better Water, Better Pharma Process
Editor Steve Kuehn talks operations and best practices with some of the industry's top water systems subject matter experts and offers a dialogue that reveals current thinking on one of the most vital, fundamental of Pharma's utilities.

Best Practices
How Humidity Mapping Differs from Temperature Mapping
Paul Daniel, Senior Regulatory Expert, Vaisala Life Science explains that over the past decade it has become more common to validate humidity as well as temperature in controlled environments in order to meet GxP requirements. Daniel offers a few special considerations for mapping humidity and best practices associated with calibration and sensor density/placement.

Technology at Work
Environmental Monitoring FAQs
Data loggers can measure nearly any physical or electrical value, so they're used in many laboratory applications, whether to record data from experiments or to handle measurement of the required temp and humidity for equipment such as refrigerators and freezers, incubators, climate chambers, autoclaves, etc. CAS Dataloggers' Stewart Thompson offers a quick guide to better application of these devices.

Efficient Development of Robust Generic MDIs
Like many drug delivery technologies, development of Metered Dose Inhalers (MDIs) is a technical challenge. Richard Moody, Global Laboratory Manager, 3M Drug Delivery Systems, explains that generic formulators must ensure that the finished product is safe, efficacious for the duration of the product shelf life, and that it complies with the requirements of the current regulatory landscape; to do so, says Moody, covering what's required to closely manage MDI development for generic inhalants.

Automation & Control
Integrating Multigenerational Automation Systems
Most automation systems include elements from different eras and vendors. Keeping those working and making improvements can present a variety of challenges. Chad Harper, Senior Director of Technology, MAVERICK Technologies, explains process manufacturing plants are famous for their tendency to keep automation systems and associated networks up and running for decades. Eventually something new needs to be implemented and Harper offers some good advice on how to manage integrating the old with the new.

Plant Tour
Pfizer Pilots Advanced Oral Solid Dose Manufacturing Plant
Pfizer announced last year a partnership with GEA Pharma Systems and G-CON Manufacturing on the design and fabrication of a prototype of a portable, continuous, miniature, and modular system ("PCMM") for oral solid dose development and manufacturing. The project is now about to move into its next phase with installation of the prototype at Pfizer's Groton R&D site and readiness for GMP expected by the end of 2015. Plant Tour covers this exciting development in processing capacity that replaces traditional batch production with continuous manufacturing operations that will rapidly and efficiently process drugs from powder to tablet.

Product Round-Up
Microbiological Contamination Detection
A product round-up from prominent equipment and technology suppliers.

Advertising & Editorial Information

For advertising information contact your district manager or Tonia Becker, Publisher, at 630/467-1300 ext. 455, Send insertion orders to Rita Fitzgerald, Production Manager, at Pharmaceutical Manufacturing, 1501 E. Woodfield Rd., Suite 400N, Schaumburg, IL 60173; fax 630/467-1120.

For editorial information, contact Steve Kuehn, Editor-in-Chief, at 630/467-1301, Ext. 410,

Pharmaceutical Manufacturing