MTS Recommends... Challenges in Analytical Method Development and Validation

Challenges in Analytical Method Development and Validation 

Susan Haigney, BioPharm International, Jun 1, 2014 

Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.

MTS Recommends... Superficially Porous Particles: Perspectives, Practices, and Trends

Superficially Porous Particles: Perspectives, Practices, and Trends

By: Szabolcs Fekete, Davy Guillarme, Michael W. Dong
LCGC Europe
Volume 27, Issue 6
Jun 1, 2014

"Columns packed with superficially porous particles (SPPs) have created considerable excitement over the last few years. Indeed, this column technology manifests the advantages of fully porous material (loading capacity, retention) and some beneficial properties of nonporous particles (kinetic performance). This review provides an updated overview of the theory behind the success of SPP technology, trends, benefits, and limitations. It also summarizes the latest developments of sub-2-µm SPPs and instrumental constraints associated with their use. Finally, it describes several applications to illustrate the performance and the universal applicability of these newly engineered particles."

MTS Recommends... Is a Sample Size of n=6 a 'Magic' Number?

Is a Sample Size of n=6 a 'Magic' Number?

By: Chris Burgess 
Pharmaceutical Technology
Volume 38, Issue 6
Jun 2, 2014

"Statistical analysis shows how much testing is needed to deliver a reliable estimate result."