Finished Product Analysis

The Impact of Material Management on Extractables and Leachables

August 03, 2022

A comprehensive understanding of potential material change can mitigate its impact on patient safety.

Inspecting Finished Products with Precision

August 02, 2022

Automated finished product inspection has been widely adopted in the bio/pharmaceutical industry.

Material Management and the Impact on Extractables and Leachables

July 02, 2022

By understanding potential material change, the impact on patient safety can be understood and mitigated.

Contamination Control for Cell and Gene Therapies Needs New Analytics

December 01, 2021

Analytical methods need a boost to ensure quality control for cell and gene therapies.

Visual Inspection: Seeing Room for Improvement?

November 02, 2021

Automatic visual inspection machines and artificial intelligence highlight inspection deficits for parenteral containers and units.

Determining Shelf Life: Reading the Stability Testing Data

October 02, 2021

Although stability testing programs for small-molecule drugs and biologics are often perceived as similar, stability programs for biologics are far more complex.

Reducing Uncertainty of an Analytical Method through Efficient Use of Replication

April 02, 2021

A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality.

Limitations and Advances in Dissolution Testing

April 02, 2021

Despite its importance in drug development, dissolution testing still has some limitations, but advances in automation and real-time monitoring are producing promising results.

Managing the Risk of Nitrosamine Impurities

March 16, 2021

Approaching Elemental Impurity Analysis

February 02, 2021

Common approaches to analyze elemental impurities for compliance with regulatory requirements are robust but still have some limitations.