05.07.14 -- Innovation In Disposable Connectors; BMS Acquires iPierian Along With Cutting-Edge mAB
The NEW USP Chapter 41: It's Easier Than You Think!
New regulations of the United States Pharmacopeia (USP) Chapter 41 have been in effect since December 1, 2013. The US Food and Drug Administration (FDA) oversees this implementation and deems it as mandatory. The major scope of this chapter pertains to balances. The balances used for weighing are required by Chapter 41 to be calibrated.
It's about weighing accurately. Are you in compliance? Learn more.
By Eric Langer, President and Managing Partner, BioPlan Associates, Inc.
The single-use application market in biopharmaceutical manufacturing is rapidly expanding and highly innovation-driven. Adoption of single-use equipment in early manufacturing has reached a level of maturity that will spill into commercial-scale manufacturing in the near term. Indeed, results from our 10th Annual Report and Survey of Biopharmaceutical Manufacturers (www.bioplanassociates.com/10th) indicate that nearly half of biopharmaceutical manufacturers and CMOs either strongly agree (18 percent) or agree (28 percent) that they expect to see 100 percent single-use facility in operation within five years.
By Karl Schick, Innovation Manager, Parker domnick hunter Process Filtration
Sensors designed for incorporation into disposable purification platforms, i.e., single-use tangential flow filtration (TFF), single-use normal flow filtration (NFF), or disposable chromatography, must meet a number of challenging requirements.
Gain the insight and contacts you need to make your single-use platforms more efficient, economical, and meet more complex drug demands at IBC's 11th Single-Use Applications for Biopharmaceutical Manufacturing conference, taking place June 9 and 10, 2014 in Boston, MA.
Bioresearch Online readers can save 20 percent off the standard rate with priority code B14187BIO20 during online registration at http://bit.ly/1jHaZ86.