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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
February 15, 2020
The need for lyophilization services is growing as a burgeoning pipeline of new biologics matures.
January 01, 2020
Temperature-sensitive biologics are lyophilized to preserve therapeutic viability, but the process presents complexities and challenges that are as yet not fully understood.
April 01, 2019
Technical advances in process understanding and control must be accompanied by a change in mindset.
February 01, 2019
Most extractable and leachable (E&L) studies are based on liquid formulations. This article examines options for E&L studies to evaluate leaching from primary packaging into lyophilized drugs.
October 01, 2018
Non-destructive surface area measurement can improve stability testing.
June 01, 2018
Rentschler Fill Solutions and Ultragenyx announce fill and finish agreement for the US commercial supply of Mepsevii.
January 18, 2018
Researchers at Purdue University and and industry experts have partnered up at the Advanced Lyophilization Technology Hub to optimize the 70-year-old freeze-drying process.
December 01, 2017
A technology roadmap aims to drive and consolidate improvements in a process that has remained unchanged for more than 70 years.
April 11, 2017
GE Healthcare continues to ramp up its offerings in the bioprocessing space with the purchase of Asymptote and a continued partnership with Zenith Technologies.
February 01, 2017
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) using a small-scale model.