July/August 2015

Biopharma Asia

July/August 2015 | Volume 4 Issue 4


Paradigm for Process Validation of Biopharmaceuticals

By: Kim H. Wong, Ph.D. Director, Facilities & cGMP Support, BioProcess Research & ...


Regulatory Pathways for Parametric Release

By: Marla Stevens-Riley, Ph.D. Senior Microbiologist Division of Regulations, Guidance, an...


An Approach to Microbiological Testing of Raw Materials Used in the Manufacture of Biologi...

By: Kim Bowers, Manager, QC Microbiology Pfizer


Choosing, Selecting, and Managing Your External Sourcing Partners

By: Firelli Alonso-Caplen, Ph.D. Senior Director, Pharmaceutical Sciences, Biotheraputics ...


Gelatin-free Softgels: Development and Optimization of Polysaccharide Capsule ShellSystems...

By: Norman Stroud, Keith Tanner, Linus Fonkwe, Elizabeth Youngblood, Randy Goodrich, and D...


Good Vibrations: Near-Infrared Spectroscopy in Pharmaceutical Analysis

By: Alfred Steinbach and Stephanie Kappes Metrohm


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

GE Healthcare Life Sciences


The Case for User-Friendly Informatics in the Pharmaceutical QA/QC Lab

By: Trish Meek, Director of Product Strategy Thermo Fisher Scientific


Managing Key Microbial Quality Control Tests within a Single Technology

By: Mark Severns Rapid Micro Biosystems


Single Use Systems in Microbiological Environmental Monitoring: A Sterile, Transparent, P...

By: Claudio Denoya, Ph.D, and Gilberto Dalmaso, Ph.D. Particle Measuring Systems


Probabilistic Evaluation – First Principles vs. Empirical

Fundamentals and Performance Characterization of Thermo Scientific TruScan Analyzers Therm...