BioPharm International March 2017

March 2017 | Volume 30, Issue 3
BioPharm International March 2017 issue
Cover Story
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics
Features
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.
A controversial naming convention attempts to explain important distinctions between biologic drugs and their biosimilar counterparts.
Although best practices are key, advances in integrated informatics platforms and automation can make it easier to ensure data integrity and improve overall laboratory efficiency.
Troubleshooting
The process control and automation requirements of single-use systems differ from those of stainless-steel equipment.
Manufacturing
Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.
Downstream Processing
Process controls get some upgrades to better reflect real-time conditions.
Supply Chain
As the November 2017 deadline nears, a surprising number of companies still don’t have a serialization plan in place. New programs aim to get them compliant in time.
Johnson & Johnson Supply Chain (JJSC) and the distributor AmerisourceBergen launched a four-week pilot program to test GS1’s EPCIS standards and to see how effectively data could be transferred between the two partners.
The author discusses the results from TraceLink and Actionable Research's Global Drug Supply, Safety and Traceability Report.
Analytical Best Practices
Process characterization and model building are essential skills and are required for modern drug development.
Perspectives on Outsourcing
Moving global manufacturing operations may be more complicated than it appears.
Ask the Expert
Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment.
From the Editor
Drug type, potential sales, and ownership factor in the race to get drugs to market.
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