Introduction and U.K.’s exit from the EU On leaving the EU, EU-REACH legislation was copied over into UK-REACH as of 01 January 2020. Applying to only England, Wales and Scotland (collectively referred to as Great Britain or GB), Northern Ireland continues to be regulated by EU-REACH. The UK-REACH transitional arrangements …
Top considerations for developing a biomarker solution and CDx strategy
When it comes to designing clinical trials with expedience and efficiency, many drug developers are choosing biomarker-driven strategies for their investigational precision medicines. As key features of developing new therapies and diagnostics, biomarkers define the disease biology, provide potential targets for new therapies and provide strong potential for market differentiation. …
How to de-risk OECD 443 studies through optimized dose level selections
The European Chemicals Agency (ECHA) recently conducted a review project regarding the design of the OECD 443 (Extended One-Generation Reproductive Toxicity Study, or EOGRTS). The project’s goal was to assess the performance of the study in terms of study design, conduct and findings to determine if the study design currently …
Faster access to biopesticide alternatives to conventional pesticides under the U.S. BPPD regulatory framework
There is pressure worldwide for better, faster access to biological alternatives to conventional crop protection chemicals (CPCs). The U.S. Environmental Protection Agency (EPA) is ahead of regions such as the European Union (EU) in revising its regulatory approaches for biopesticides and in having a division dedicated to them, namely, the …
Program management services are now offered as part of Labcorp’s Preclinical Oncology Services
When it comes to discoveries in oncology, cancer patients can’t wait, which means neither can you. At Labcorp Preclinical Oncology, we understand there are many steps, phases and regulations to wade through to get to a lead drug candidate—all while time is of the utmost importance. We are excited to …
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 …
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 …