BioPharm International December 2016

December 2016 | Volume 29, Issue 12
BioPharm International December 2016 Issue
Cover Story
Job security may have increased, but biopharma professionals remain somewhat dissatisfied with pay levels.
Andrew Bulpin, head of Process Solutions Strategic Marketing & Innovation at MilliporeSigma spoke with BioPharm International about the requirements of expression systems in biosimilar development.
The baculovirus-insect cell system can produce large quantities of complex protein in a short period of time.
Biopharma must see regulators as partners in their efforts to provide safe and effective therapies.
What will manufacturers have to do to ensure the continued uptake of biosimilars?
Understanding of endotoxin assays and a range of detection technologies are essential for effective testing.
A consistent approach in assessing risk is an important aspect of successful quality management.
Peer-Reviewed Research
This report describes the first known attempt at quantifying the success of such processes in inducing nucleation on a 56–m2 freeze dryer operating at a load of 195,960 vials.
John Ward, vice-president of Engineering at Patheon, discusses the potential for cross contamination in the manufacture of biopharmaceuticals.
Downstream Processing
A novel coiled flow inversion reactor (CFIR) improves process productivity and performance.
Regulatory Beat
Republican control of Washington promises overhaul of healthcare and medical product regulation.
Perspectives on Outsourcing
Biosimilars may be the key to CMO growth.
Ask the Expert
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on a limited budget.
From the Editor
Rookie API developers beat pharma at its own game.
Product Spotlight
By BioPharm International Editors
Zeiss’s Axio Observer inverted microscope platform includes new automation features, allowing researchers to perform multimodal imaging of living and fixed specimens.
By BioPharm International Editors
The Prominence Ultra-Fast Preparative and Purification Liquid Chromatograph (UFPLC) from Shimadzu enables fast recovery of highly purified target compounds from complex samples including organic synthesis reaction mixtures and natural products.
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