<span>Antibody Reagent Spotlight – Generating positive control antibodies for your Anti-Drug Antibody (ADA) assay</span>
December 6, 2023

Antibody Reagent Spotlight – Generating positive control antibodies for your Anti-Drug Antibody (ADA) assay

Biopharmaceuticals, including monoclonal antibodies, recombinant proteins, hormones, cytokines, growth factors, gene therapy products are a crucial class of therapeutic agents that have transformed the treatment of various diseases. As these complex molecules are introduced into patients, it is essential to monitor potential immunogenic responses. Biopharmaceuticals, including monoclonal antibodies, recombinant proteins, hormones, cytokines, growth factors, gene therapy products are a crucial class of therapeutic agents that have transformed the treatment of various diseases. As these complex molecules are introduced into patients, it is essential to monitor potential immunogenic responses. The potential immunogenicity of biological products results in the elicitation of anti-drug antibodies (ADA).  Anti-Drug Antibodies (ADAs) are immune responses generated against the therapeutic drug itself. The assessment of ADAs is a vital component of biopharmaceutical development. To ensure the reliability and sensitivity of ADA assays, positive control antibodies are generated as key reference materials.
<span>Recognizing National Kidney Month by Breaking Down Barriers to Improve Clinical Trials for Glomerular Diseases</span>
June 3, 2021

Recognizing National Kidney Month by Breaking Down Barriers to Improve Clinical Trials for Glomerular Diseases

To raise awareness about kidney diseases during National Kidney Month, we’d like to focus on rare renal diseases and the importance of studying not only adults but the pediatric population as well. Several rare glomerular diseases1 can impact the kidney’s important cleansing function. Tiny clusters of looping blood vessels, called glomeruli, sit within each kidney’s approximately 1 million nephrons. Similar to other kidney diseases, glomerular diseases often progress silently and remain undetected until the disease becomes more advanced. Once diagnosed, treatment options have historically been limited, but recent clinical trials and drug approvals have been encouraging.
<span>Five Benefits of Risk-Based Quality Management (RBQM) for Clinical Trial Data</span>
June 3, 2021

Five Benefits of Risk-Based Quality Management (RBQM) for Clinical Trial Data

Risk-based quality management methodologies address risk control and management during execution of a clinical trial. RBQM adoption has generated valuable benefits for project management and clinical operations, changing the way trial monitoring is done. However, data management activities are ideally suited for an RBQM approach as well. Today, we explore five benefits data managers can gain from implementing a risk-based quality management approach and the enabling applications.
<span>Webinar: Advancing Your Neurodegenerative Biomarker Strategy Beyond Discovery</span>
June 8, 2021

Webinar: Advancing Your Neurodegenerative Biomarker Strategy Beyond Discovery

On April 15, we hosted the virtual conference, “Advancing Your Neurodegenerative Biomarker Strategy Beyond Discovery.” For study teams working to develop treatments for patients suffering from neurodegenerative diseases, the need to leverage new techniques quickly and effectively is imperative. This topic is vital, as nearly 50 million people worldwide suffer from Alzheimer’s or related dementia1, and 10 million are living with Parkinson’s Disease2.
<span>A Creative Solution to Address the Biosimilar Boom</span>
July 26, 2021

A Creative Solution to Address the Biosimilar Boom

Identifying viable study sites presents a challenge in many clinical trials. Biosimilar development is especially challenging as the number of sponsors preparing to broaden access to today’s blockbuster biologics, by providing lower-cost biosimilar alternative, continues to grow. While this flood of research activity will make a significant improvement for patient access to breakthrough treatments, it has also created an increasingly competitive environment for finding suitable, experienced sites.