Technical Expertise

Reproductive Toxicology & the EPA’s Tiered Testing System

Reproductive Toxicology & the EPA’s Tiered Testing System

The endocrine system comprises myriad glands, hormones and receptors throughout the body that regulate biological processes from birth to death. Chief among those processes is the differentiation, growth and function of the human reproductive system. Human...

The Secret Recipe for Extractable/Leachable Testing Success

The Secret Recipe for Extractable/Leachable Testing Success

Every great chef has a secret "something" to their name—a recipe, a technique, an ingredient. It stands to reason that a lab essentially concerned with chemistry would also have its own special something. After all, cooking is a form of chemistry, isn't it? While some...

The Many DMPK Challenges of Cancer Treatment ADCs

The Many DMPK Challenges of Cancer Treatment ADCs

Since German Nobel laureate Paul Ehrlich developed the concept of the “magic bullet” in 1907, researchers have chased the possibility relentlessly. Ehrlich’s immune response research proposed killing specific microbes without harming the body itself, a goal which...

6 Essential Qualities in a Drug Safety Assessment Testing Partner

6 Essential Qualities in a Drug Safety Assessment Testing Partner

Drug safety assessment is a highly complex, involved and molecule-specific process, which is why most drug developers benefit from working with a testing partner. But not all CROs are created equal. Here are six characteristics to consider. Safety assessment studies –...

What Is Bioanalytical Testing & Method Validation?  

What Is Bioanalytical Testing & Method Validation?  

To be effective and safe, a therapy must contain precise drug concentration. That’s why bioanalytical testing is required during the drug development process. For robust and accurate data, bioanalytical testing relies on effective method development and validation. In...

What Is E/L for Biopharma? 4 Essential Things to Know

What Is E/L for Biopharma? 4 Essential Things to Know

Extractable and leachable (E/L) studies are becoming more and more important to drug development programs. Here’s why – and an overview of what E/L looks like for biopharma. As drug manufacturing changes and becomes more flexible with plastic systems, the requirements...

Everything You Need to Know About Single-Use Systems

Everything You Need to Know About Single-Use Systems

Pharmaceutical manufacturers have used single-use products since the 1990s, when plastic filters and tubing were integrated with stainless steel bioreactors, revolutionizing biomanufacturing. Prior to this breakthrough, manufacturers were forced to clean and prepare...

QWBA vs. Mass Balance Studies

QWBA vs. Mass Balance Studies

Quantitative whole-body autoradiography (QWBA) and mass balance testing are equally important processes to gather data on a drug candidate’s absorption, distribution, metabolism, and excretion (ADME) properties.  While both QWBA and mass balance can give details...

What Is IND-Enabling Testing & What Does It Include?  

What Is IND-Enabling Testing & What Does It Include?  

IND-enabling testing is a cornerstone of the drug development process, helping researchers predict safety concerns and estimate safe and efficacious starting doses for clinical trials. Planning ahead, understanding the tests you need to conduct, and diligent tracking...

In Vivo ADME Testing in Drug Development: A Short Guide

In Vivo ADME Testing in Drug Development: A Short Guide

In vitro and in vivo ADME studies provide valuable data about a test article as it moves through preclinical development. In this short guide, we provide an overview of in vivo ADME testing, including why it’s important and how it works. For a successful...