Drug Substance Analysis

Data Integrity's Impact in Drug Substance Testing

September 01, 2023

Interpreting data and understanding the various components of biologic drug substance testing is an important skillset to know as a lab personnel.

ADME Studies: Determining Promising Drug Compounds

November 02, 2022

Experts discuss factors that can affect the outcome of an ADME study, signs that a drug compound shows promise, red flags, and key parameters to determine safety and efficacy.

Elemental Impurity Analysis Crucial to Patient Safety

July 06, 2022

To ensure patient safety, drug products must be tested for elemental impurities that pose risk.

Ensuring Patient Safety Through Elemental Impurity Analysis

June 02, 2022

Analyzing elemental impurities in drug products is—much like other analytical testing—primarily aimed at ensuring patient safety.

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.

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.

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.

Meeting Specificity Needs for Biologic Drug Substance Testing

January 02, 2021

Traditional biologic-based testing methods may need an upgrade to properly test newer therapeutic modalities.