Automating Bioprocesses
The process control and automation requirements of single-use systems differ from those of stainless-steel equipment.
Biosimilar Names Prove Difficult to Define
A controversial naming convention attempts to explain important distinctions between biologic drugs and their biosimilar counterparts.
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.
Strategizing a Shortcut to Market
Drug type, potential sales, and ownership factor in the race to get drugs to market.
Covering Global Regulations in a Quality System
Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment.
Will Pharma Manufacturing Move Back to the US?
Moving global manufacturing operations may be more complicated than it appears.
Serialization Hits the Home Stretch
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.
Harnessing Advances in Informatics to Ensure Data Integrity
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.
Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics
Process Characterization Essentials: Process Understanding and Health Authorities Guidance
Process characterization and model building are essential skills and are required for modern drug development.
Testing GS1’s EPCIS Standards in the Real World
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.
Speed Bumps on the Road
The author discusses the results from TraceLink and Actionable Research's Global Drug Supply, Safety and Traceability Report.
BioPharm International, March 2017 Issue (PDF)
Click the title above to open the BioPharm International March 2017 issue in an interactive PDF format.
Reconciling Sensor Communication Gaps
Process controls get some upgrades to better reflect real-time conditions.
