Analytical Best Practices

The Importance of Partnering for Bioanalytical Studies

June 01, 2020

Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.

Keeping Aggregation Under Control

April 07, 2020

Characterizing and controlling protein aggregation is vital to ensure safety and efficacy of a biopharmaceutical product. In this interview, important aspects of protein aggregation and the tools available to address this issue are discussed.

Meeting E&L Expectations

December 02, 2019

As regulatory bodies extend the oversight of E&L testing, companies working with drug products need to make provisions on how to best comply with the evolving expectations.

Essentials in Bioassay Development

November 01, 2019

Developing an effective bioassay is crucial for determining the potency of a drug substance or finished drug product. This article gives an overview of how to avoid most problems associated with correct bioassay development.

The Latest in the Laboratory

November 01, 2019

The following details some of the latest tools and systems available for biopharmaceutical laboratory operations.

Dealing with particulates or aggregates in biologics

September 01, 2019

Particulates or aggregates are a notable challenge for injectables, but there are several methods available to help with identification during formulation and development.

Putting Biopharma Stability Testing Under the Microscope

September 01, 2019

Stability testing for biologics is more complex than for small-molecule drugs, so companies should be aware of the potentially serious issues that can be costly and jeopardize drug development.

Container Closure Integrity Testing of Finished Sterile Injectable Product

September 01, 2019

As regulatory guidance has evolved, changes in CCIT testing have also become apparent. In this article, possible CCIT strategy approaches are outlined.

An Analytical Approach to Biosimilar Drug Development

October 15, 2018

Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.

Glycan Analysis Best Practices

October 15, 2018

Experts discuss best practices for performing glycan analysis.