Antibody drug-conjugates (ADCs): Analytical considerations for QC release, stability testing, characterization and comparability

An antibody-drug conjugate (ADC) represents a biopharmaceutical molecule comprising the monoclonal antibody (mAb) delivery component, which is conjugated traditionally to a highly potent cytotoxin via a chemical linker though other conjugated moieties are being developed. Regardless of the conjugate, the analytical approach is similar. All three components, mAb, cytotoxin and chemical linker, are crucial to the efficacy of the ADC, as well as the drug antibody ratio (DAR). Additionally, they must be addressed when it comes to the selection of analytics for release testing, stability testing, as well as characterization and comparability analysis. Adding to the complexity of analyzing ADC product is the analytical requirement for mAb intermediate, cytotoxic drug intermediate, drug substance and drug product, with the production of these materials often occurring at different manufacturing sites.

Five tips for healthy grilling this summer

Summer is in full swing and it’s time to enjoy the benefits of the season. Cooking and eating outdoors are popular options for parties, holidays, social gatherings, events or just plain fun. According to the Hearth, Patio & Barbecue Association’s 2023 State of the Barbecue survey, grilling out continues to grow in popularity. Approximately 80% of all homeowners and 70% of U.S. households own a grill and/or smoker, up from 64% in 2019. And 35% own two grills or more. 

Cancer and clinical trials: two survivors share their journeys

Cancer and clinical trials: two survivors share their journeys

COVID, the flu, and RSV: Now is not the time to let your guard down

Influenza (the flu) has been a part of our lives for a long time. We have been dealing with COVID-19 for almost 3 years now. Respiratory syncytial virus (RSV) might seem like a newcomer because it has been in the headlines recently, but most babies have an RSV infection before they turn 2 years old. Even though we have learned to deal with these viruses, that doesn’t mean we should take them for granted.

Is a Clinical Trial Right for My Child?

Every year, hundreds of millions of prescriptions are given to children for the treatment of a wide range of conditions. However, the U.S. Food and Drug Administration (FDA) reported in 2016 that only about 20% of prescribed medications were actually approved for use in children. In Europe, more than 70% of marketed drugs have been not been licensed for use in children.

What are mRNA Vaccines?

Vaccines play a critical role in the health and well-being of our society at large. They help drastically reduce the contraction and spread of infectious diseases, in turn limiting the severity of harm caused. Vaccines not only help protect the individual receiving the vaccine, but also everyone they come into contact with. We’re all in this together.

The Significant Contribution of Clinical Trials in Bringing The Very Latest Healthcare Treatments to Humanity

The global pandemic has brought medical research into the spotlight. “Clinical Trials”, “Safety”, “Pharmacovigilance” and “Epidemiology” have been thrust into our lexicon, and with thousands of clinical trials related to COVID-19 taking place, now is a good time to review some basics.

The Different Stages of Cancer and What They Mean

A cancer diagnosis can be scary, difficult to process and understand, and leave you and your loved ones unsure of how to move forward. While it is certainly beneficial to detect cancers as early as possible, today we have treatment options available at each stage. Most types of cancer are divided into 4 (or 5 stages if we include the so called “stage 0”): Stage 0, Stage I, Stage II, Stage III, and Stage IV – with Stage IV being the most advanced. In addition to this scale, another system — the TNM (defined below) staging system — is often used to explain stages of cancer.

The Liver Disease You Might Not (But Should) Know About: Nonalcoholic Steatohepatitis (NASH)

If you’ve never heard of NASH, you’re not alone. NASH is a chronic, silent liver disease that worsens over time.

The Four Stages of Heart Failure

Heart failure affects approximately 64 million people worldwide.1 Although heart failure is a serious medical condition that should not be taken lightly, it does not mean that your heart has stopped working. Consider the following key facts of heart failure.