January/February 2016

Biopharma Asia

January/February 2016 | Volume 5 Issue 1


Regulatory Approaches for Supporting Innovation in Pharmaceutical Manufacturing

By: Sau (Larry) Lee, Ph.D., Associate Director for Science Xiaochuan Yang, Ph.D., Visiting...


Developing a Strategy for Container and Closure Integrity –The Value of USP Guidance

By: Donald C. Singer, Global Lead Quality Manager, Microbiology R&D GlaxoSmithKline


Global Development of Biosimilars: Understanding and Reducing Regulatory Uncertainty in th...

By: Ajaz S. Hussain, Ph.D. Insight Advice and Solutions LLC. Frederick, MD 21702, USA*, an...


Characterisation of Host-Cell Proteins using Mass Spectrometry Enables Effective Purificat...

By: Li Zang, Senior Scientist, Analytical Development Biogen, Cambridge, MA 02142, USA


Understanding Single-Pass Tangential Flow Filteration and the New Era of Bioprocessing

Engin Ayturk(1,*), et. al., (1) Pall Life Sciences – BioPharm Applications R&D,...


Improvement of Physical Stability of Soft Gelatin Capsules by Film Coating

By: Yinqi Zhou and Irena McGuffy Catalent


The Use of Capto™ Core 700 and Capto Q ImpRes in the Purification of Human Papillom...

GE Healthcare Life Sciences


Development and evaluation of a research screening assay to elucidate potential endogenous...

By: Randall Logan1, Sirantha Perera1, J.D. Pipkin2 and Jeffrey P. Krise1,* Captisol 1Depa...


SYLOID® XDP Silica: Optimised for Liquisolid and Lipid-based Formulations

Grace


Long Term Compatibility of Excipients in Soft Gelatin Capsules

By: Yi Zeng, William Bell, Irena McGuffy
 Catalent


Lifetime performance study of MabSelect SuRe™ LX during repeated cleaning-in-place

GE Healthcare Life Sciences