Blog
The Inherent Challenges of Antibody-Drug Conjugate (ADC) Bioanalysis
Antibody-drug conjugates (ADCs) target and destroy cancer cells like few available therapies. Highly potent and laser-focused, these tools have been around since 2000; currently, just 14 of them have been approved for use. ADCs are made up of a monoclonal antibody, a...
4 Critical In Vitro Genotoxicity Assays for Preclinical Drug Development
Genetic toxicology studies are an integral part of the basic toxicological information package used in the risk assessment and decision-making process for a new drug. In this short guide, we walk through four critical in vitro genotoxicity assays drug developers need...
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...
As Requirements for E/L Testing Continue to Increase—Here Is What You Need to Ask When Selecting A Testing Partner
U.S. Pharmacopeia (USP) recently issued two new chapters (665/1665) on production equipment and patient safety for polymeric components and systems used in biomanufacturing. These new requirements demonstrate a heightened focus on the extractables and leachables in...
5 Critical Nonclinical Toxicology Studies Required for IND Submission
Toxicology studies are required for Investigational New Drug (IND) and New Drug Application (NDA) submissions in order to fully define the safety profile of a drug – and maintain the highest level of patient safety. In this short guide, we cover the core battery of...
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
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
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?
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
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
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 and 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...