Phase I-III randomized controlled trials alone are not generating enough data to extrapolate conclusions and theories about therapeutics to the global population. Not all drugs demonstrate the same efficacy in the real world as shown in the clinical trials. Because of this, we are seeing a rise in long-term follow-up …
Exploring metastatic breast cancer immunotherapies: Are ADCs and ICIs the answer?
Breast cancer is the most common malignancy in women and the second most common cancer worldwide.1 Rates of breast cancer are increasing in many parts of the world, reflecting its association with social and lifestyle factors related to economic development, as well as increases in life expectancy.2 Although the disease …
Cell and Gene Therapy Answers: Bioanalytical support for cell and gene therapy
Your source for answers to the complex challenges of cell and gene therapy development. We recently spoke with Daniel Sikkema, executive director of global immunochemistry at Labcorp drug development, regarding bioanalytical support for cell and gene therapy modalities. He shared some of the current challenges in cell and gene therapy, …
Labcorp to open new kit production innovation base in Suzhou, China
In late July, Labcorp joined the signing ceremony of its kit production innovation base project in Suzhou New District, China. The event was held and organized by the Suzhou New District government and saw attendance from city leadership officials, including Deputy Mayor of Suzhou city, Mr. Xiaodong Tang. The Kit …
Generation of polyclonal anti-idiotype antibodies
An idiotype is a unique antigen-binding site in an antibody and is made up of several epitopes in the variable region. Antibodies raised against the idiotype of a given antibody are called anti-idiotypic antibodies or commonly anti-Ids. These anti-Ids are highly specialized reagents that are produced against human monoclonal antibody …
More than a partner: How Labcorp Central Laboratories managed the 65-day Shanghai lockdown
With five global central laboratories, Labcorp understands the value of around-the-clock support to advance clinical trial testing, but the recent 65-day lockdown at their Shanghai facilities gave new meaning to “around the clock.” Understanding the severity of the situation On March 28, 2022, the entire population of Shanghai was suddenly …
New OECD TG 497: Interpretation and application of defined approaches for skin sensitization assessment
The advent of requiring multiple non-animal in vitro alternatives for skin sensitization assessments has prompted the Organisation for Economic Co-operation and Development (OECD) to publish new guidance to outline the approaches for data interpretation from multiple non-animal test methods. When used together in specific combinations, these methods will aid with …
Expanded laboratories to match your growing needs in vaccine development and antibody reagents
Continued growth in the development of large molecule therapeutics has constrained resources for in vivo studies and in vitro sample analysis. In addition, the COVID-19 pandemic has brought renewed urgency to vaccine research and development, emphasizing a need to protect the world against existing, re-emerging and emerging pathogens and accelerate …
PK, PD and immunogenicity assays to support clinical trials – building the bigger picture
Understanding how a body processes a therapy and a therapy’s effect on the body is a critical step for understanding safety and efficacy to support clinical trials. But the process of characterization differs between small-molecule therapies and biotherapeutics. Associate Director of Early Scientific Engagement at Labcorp Drug Development, Robert Nelson, …
Non-GLP sample analysis for ocular biodistribution studies
Traditional bioanalytical service providers are geared toward analyzing large sets of samples under various regulatory guidelines, such as large nonclinical and clinical studies, which are heavily regulated. This puts a heavy burden on these service providers, creating long lead times, resource constraints and lack of flexibility. Currently, many bioanalytical laboratories …