Navigating the complexities of the Biocidal Products Regulation

Biocidal products are used to control unwanted organisms (e.g., pests, such as rats, or micro-organisms, like bacteria) that are harmful to the health of humans, animals or the environment. They play an important role in everyday life and are regulated in the European Union (EU) and European Economic Area (EEA) by the European Chemicals Agency (ECHA). A biocidal product must be authorized before it can be placed on the market, although exemptions apply for active substances included within ECHA’s Review Programme.

Biocide product authorization process

From initial planning to post-submission support, Labcorp can help you navigate every stage of authorization for your biocide.

Multiparameter characterisation of human alveolar macrophage-epithelial co-culture (ImmuLUNG™) following exposure to whole smoke

CORESTA Congress 2024 -- ImmuLUNG™ cultures were exposed to whole smoke (WS) generated from 1R6F Kentucky Reference using a Vitrocell® VC10® smoking robot at varying airflows. The effects of WS on cytotoxicity, oxidative stress, epithelial barrier permeability, cytokine secretion, gene expression and individual cell phenotype via high content imaging analysis were assessed. The ImmuLUNG™ epithelial component exhibited high TEER values. Concentration-dependent viability and oxidative stress responses were observed, as indicated by 8-isoprostane/LDH release. Gene expression analysis revealed relevant macrophage RNA markers and upregulation of genes controlling macrophage production, differentiation, and function. Proteomic analysis showed increased expression of inflammatory signaling proteins and protein expression changes associated with oxidative stress control. High-content image analysis of ImmuLUNG™ macrophages revealed morphological changes, indicating assessment of macrophage endpoints are compatible with WS exposure. 

Utilizing the in vitro micronucleus assay microflow endpoint on V79 cells after treatment in 24-well plates

CORESTA Congress 2024 -- Within the standard genotoxicity test battery, the in vitro micronucleus (IVMN) test is an option for detecting chromosomal damage. As standard this is performed through slide preparations and manual scoring. Improving timelines and increasing cell numbers analysed is achieved through flow cytometry and staining methods. This method was utilised with V79 cells cultured in 24-well plates. These were treated with the OECD 487 test chemicals including nicotine and Total Particulate Matter (TPM) (ISO 20778:2018) generated from 3R4F Kentucky Reference, eluted in DMSO. Endpoints were measured using the Litron™ MicroFlow kit. Cytotoxicity was measured by relative population doubling (RPD), supported by the use of Cell Sorting Set-up Beads (Invitrogen™) during flow cytometry assessment. The Litron™ MicroFlow kit was used to stain and lyse the cells, then micronucleus (MN) induction was assessed on a flow cytometer. Results showed dose related increases in MN induction for all expected positive OECD test chemicals. 3R4F TPM at 3+21 -S9 showed a slight increase, prior to cytotoxicity. 3+21 +S9 showed dose-related induction. 24+0 -S9 showed increases to MN induction. This validation study confirmed the correct functioning of a high throughput IVMN assay by flow cytometry, with treatment in 24-well plates

Validation of the Vitrocell® 48 2.0+ 24-well mammalian module for assessing cigarettes and eHTPs: Evaluation of dilution airflow, dose resolution and 3D tissue suitability

CORESTA Congress 2024 -- The use of 3D in vitro airway tissue models that closely mimic the physiological architecture and microenvironment of the human respiratory system is critically important when studying aerosol exposure. Presence of a pseudostratified mucociliary epithelium and mucus secreting goblet cells help to provide a more accurate representation of the deposition, dissolution and clearance patterns of inhaled aerosols during human exposure. The objective of this study was to validate the Vitrocell® 48 2.0+ 24-well module by quantifying delivered dose across a range of dilutions from both reference cigarettes and electronically heated tobacco products (eHTPs). The study findings revealed low variation within dilution airflow, overall good dose resolution and supports the use of this module in relevant toxicological investigations and risk assessments.

A new way to fight cervical cancer: How artificial Intelligence is transforming pap test screening

Screening is critical for effective prevention and treatment of many cancers, and cervical cancer is no different. Each year in the U.S., an estimated 26.4 million Pap tests are ordered, and an estimated 11,500 new cases of cervical cancer are diagnosed.  

Recurrent pregnancy loss: How genetic testing can make all the difference

Richelle Marty and her husband had been trying to conceive for nine months when they decided it was time to explore other options. Despite monitoring their fertility at home, they were perplexed by their fertility challenges.

Labcorp Expands Sexually Transmitted Infection (STI) Test Offerings with Rapid Syphilis Test

Labcorp to serve as the exclusive NOWDiagnostics (NOWDx) distributor for clinical testing in the U.S. , offering First to Know® Syphilis Test nationwide BURLINGTON, N.C. , Oct 10, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced

Labcorp Declares Quarterly Dividend

BURLINGTON, N.C. , Oct. 10, 2024 /PRNewswire/ -- Labcorp  (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today that its Board of Directors has declared a cash dividend of $0.72 per share of common stock. The dividend will be payable on December 13, 2024 ,

Labcorp Biopharmaceutical CMC Services Subunit vaccines: Analytical techniques for characterization, release and stability testing

Since the development of the first vaccines that comprised inactive or attenuated pathogens, there has been a drive to continue to produce safer vaccine formulations that are more effective, cause fewer side effects and are safer overall. This has resulted in the development of a wide range of vaccine modalities, including viral vector-based component vaccines and DNA/RNA vaccines. One consequence of this has been the development of subunit vaccines, which are more chemically defined and have an enhanced safety profile. Subunit vaccines are vaccines that contain only the antigenic component(s) of a pathogen.