Manufacturing

Articles

The need for lyophilization services is growing as a burgeoning pipeline of new biologics matures.

Lyophilization Services Gain Ground Amid Growing Biologics Market

Temperature-sensitive biologics are lyophilized to preserve therapeutic viability, but the process presents complexities and challenges that are as yet not fully understood.

Lyophilization Presents Complex Challenges

Editor of Pharmaceutical Technology Europe

Technical advances in process understanding and control must be accompanied by a change in mindset.

Changing Perceptions: An Understanding of Lyophilization Advancements

Steven A. Zdravkovic is a senior research scientist at PPD Laboratories, Middleton, WI.

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. 

Understanding Leaching from Stoppers into Lyophilized Drugs

Jeff Kenvin is chief scientific officer at Micromeritics.

Non-destructive surface area measurement can improve stability testing.

Using Nondestructive in-situ Measurements to Ensure Lyophilized Product Stability

Rentschler Fill Solutions and Ultragenyx announce fill and finish agreement for the US commercial supply of Mepsevii.

Rentschler Fill Solutions Announces Agreement for US-Market Drug

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. 

Experts Partner to Optimize Lyophilization

Agnes Shanley is senior editor of BioPharm International.

A technology roadmap aims to drive and consolidate improvements in a process that has remained unchanged for more than 70 years.

Modernizing Lyophilization

Randi Hernandez was science editor at BioPharm International from September 2014 to May 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.

GE Healthcare: The Next Cell and Gene Therapy Manufacturing Giant?

Peter J. Martin is investigator, Biopharmaceutical Product Sciences, GlaxoSmithKline.

James D. Colandene, PhD, is manager, Biopharmaceutical Product Sciences, GlaxoSmithKline.

W. Aaron Pruett is drug product process engineer, Novavax.

Douglas P. Nesta, PhD, is director, Biopharmaceutical Product Sciences, GlaxoSmithKline.

Kashappa Goud Desai, PhD, is investigator, Biopharmaceutical Product Sciences, GlaxoSmithKline, kashappa-goud.x.desai@gsk.com

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.

Manufacturing, Lyophilization