Pharmaceutical Manufacturing Preview

November 2015 Issue Preview

Ad Closing: October 15, 2015 | Material Closing: October 23, 2015

Biopharmaceutical Technical Resources Guide
Soaring to New Heights -- Biopharmaceuticals in 2015
If one follows the money in Pharma, the road it paves leads to the biopharmaceutical segment. Pharmaceutical Manufacturing's editor Steven Kuehn goes up 30,000 feet and offers his view of the industry at altitude as well as its trajectory to become one of Pharma's most high-flying sectors.

New Technologies for Downstream Efficiencies
The biopharmaceutical industry has seen dramatic improvements in upstream manufacturing yields over the past 30 years, says BioPlan Associates Eric S. Langer, who sees promise in continuous purification. However, increased efficiencies in upstream operations have contributed to downstream bottlenecks, as these filtration and purification operations have failed to keep pace with upstream developments.

Process and Facility Design for a Monoclonal Antibody Facility
According to Christian Cattaruzza and Sebastien Ribault, of Millipore S.A.S., the biological drug products market is expanding, especially in emerging economies. To support this expansion the flexible factory concept is becoming an attractive path to capacity because a single-use facility can be designed for ease of use, minimized contamination risk and flexibility in mind.

Leveraging Third-Party Audits in the Pharmaceutical, Biotechnology & Medical Device Industries
Daniel Fishman, Senior Consultant, Complya Consulting, finds those in the competitive and highly regulated biotechnology and medical device industries understand the need to balance operational efficiency with regulatory compliance. Making changes to processes requires overcoming challenges arising from these often competing interests.

Biomagnetic Separation, Thinking Bigger Part I
Contrary to popular belief, biomagnetic separation is ready for large-scale processing, says Luis M. Martinez, PhD. CSO at SEPMAG. Separation is a key process used in life science. The molecules the industry is interested in are usually found in a matrix that contains numerous other biological substances. Even high-value pharma processes such as protein purification downstream process can lead to losses of 50-80 percent. However, there are ways to combat these losses. The authors explain how biomagnetic separation is a methodology that is proven itself ready for commercial-scale extraction/isolation of these molecules.

Single-Use Integrity Testing Goes Mobile
Amber Sherrick, of ASI says drug manufacturers are adopting Point-of-Use Testing to support the flexibility and mobility of the single-use systems have found a permanent place in bioproduction facilities.

Advertising & Editorial Information

For advertising information contact your district manager or Mark Wiebusch, Publisher, at 630/467-1300 ext. 393, 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