IN THIS ISSUE 10 FROM THE BOARD


Bringing Poorly Soluble Molecules to Market with Bioavailability Enhancement Technologies


Ronak Savla, Fellow of the Catalent Applied Drug Delivery Institute Jeff Browne, Director, Science & Technology, Rx Softgel Vincent Plassat, Scientific Affairs Manager


22 BIOPHARM PROCESSING


Global Biomanufacturing Trends, Capacity, and Technology Drivers: Industry Biomanufacturing Capacity Overview


Patti Seymour, Senior Consultant Dawn M. Ecker, Consultant BioProcess Technology Consultants, Inc.


32 FORMULATION AND DEVELOPMENT


Challenges and Opportunities in Developing Up-to-Date USP–NF Excipient Monographs Tong (Jenny) Liu, PhD1


, Catherine Sheehan, MS2


Convention, Rockville, MD 2


Rockville, MD 3


Silver Spring, MD , and Steven Wolfgang, PhD3


1Scientific Liaison for Excipients and Harmonization, United States Pharmacopeial Senior Director, Science –Excipients, United States Pharmacopeial Convention, Lead Consumer Safety Officer, United States Food and Drug Administration,


» 48 SPECTROSCOPY


Independence and Dependence in Calibration: A Discussion of FDA and EMA Guidelines


Rodolfo J. Romañach, PhD Engineering Research Center for Structured Organic Particulate Systems (C-SOPS), Department of Chemistry, University of Puerto Rico, Mayaguez Campus, Mayaguez, PR


55 MANUFACTURING


Pharma Equipment Budget Expansion Fueling Quest For Operational Excellence


Steve Kuehn Executive Content Director, That’s Nice LLC/Nice Insight


58 ROUNDTABLE Controlled Release Technologies and Trends


63 RESEARCH Sponsor Company Size Influences Contract Research Activity


Guy Tiene Strategic Content Director, That’s Nice / Nice Insight


SPECIAL FEATURES 8


REGULAR FEATURES Social Media Connections


9 CNPerspectives 46 An Interview with MilliporeSigma 68 An Interview with MEGGLE Group Wasserburg 70 P.I.N. Points


6 A Message from the Editor 7 Editorial Advisory Board 30 Editor's Top Tech 66 Equipment Focus 72 Advertiser's Index


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| May/June 2016


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