Elemental impurities per USP and ICH q3d guidelines

Elemental impurities in a drug product may arise from several sources. These sources may include impurities in starting raw material, reagents, catalysts intentionally added during synthesis, contaminants due to interaction with components in the manufacturing processes or container closure systems. To keep the number of elemental impurities within the limits provided by United States Pharmacopeia (USP) 232, the concentration of these impurities should be monitored. The raw materials should be tested before they are used for manufacturing. The manufacturing components coming in contact with the drug product should also be tested for these elemental impurities since they can also be a contributing factor, especially if exposed to elements further the process, closer to the final product. These elemental impurities, —in addition to having potential toxicological effects, —may adversely impact a drug’s stability, leading to loss of efficacy or other unintended effects.

UK-REACH alternative transitional registration model (ATRm)

Public consultation on proposals being put forward by the Department for Environment, Food & Rural Affairs on an alternative transitional registration model (ATRm) is open until July 25, 2024.

Insights into cell seeding and the tea leaf phenomenon

Proper cell culture seeding is crucial for successful experiments that involve testing for cellular reactivity to determine toxic potential. This is particularly important because the outcome of the study (pass/fail) includes examining the cells under the microscope and evaluating the cellular morphology and confluency; this can be assessed if an appropriate cell density is achieved and there is an overall even distribution of cells in the well during seeding. The method and techniques used for proper cell culture seeding may vary depending on the testing lab; therefore, having a clear understanding of the mechanism behind cell seeding is beneficial.

Analytical performance of the plasma β-Amyloid 1-40 and 1-42 assays on the Fujirebio® LUMIPULSE® G1200 to support Alzheimer’s Disease clinical trials

AAIC 2024 -- Alzheimer’s Disease (AD) is a major neurodegenerative disorder characterized by amyloid deposits in brain tissue and represents a continuously increasing global burden in need of disease-modifying therapeutic options. Amyloid beta 1-42 (Aβ1-42) and 1-40 (Aβ1-40) peptides and the amyloid beta 1-42/1-40 ratio are hallmarks of AD and are commonly monitored in cerebrospinal fluid (CSF) along other AD biomarkers, to support diagnosis and management of AD patients. Over the past few years, blood-based AD biomarkers have emerged as highly relevant and more practical alternatives to CSF biomarkers, and further technical performance characterization of the associated assays would be beneficial to the AD research and medical community. The LUMIPULSE® G β-Amyloid 1-42 and 1-40 Plasma assays are two-step chemiluminescent enzyme immunoassays (CLEIA) performed on the LUMIPULSE G1200 system and designed for the quantitative measurement of Aβ1-42 and Aβ1-40 in plasma specimens. We validated these two assays in EDTA plasma specimens in a CAP/CLIA environment, utilizing CLSI guidelines in setting validation parameters and acceptance criteria.

Amanda Wilson

Amanda Wilson currently serves as the director and global head of LC/MS method development and validation, bioanalytical chemistry. In this role, she provides leadership and oversight for all bioanalytical method development and validation activities across LC/MS bioanalytical sites in the U.K. and North America. Amanda is responsible for ensuring the scientific quality and timely d8elivery of these studies, as well as managing the scientific evaluation of new LC/MS bioanalytical opportunities to meet evolving market needs.

Labcorp Declares Quarterly Dividend

BURLINGTON, N.C. , July 25, 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 September 13, 2024

Three wellness tips to prepare your family for a healthy school year

The latter part of summer can be bittersweet. While many parents and families are still enjoying fun outdoor activities and sunshine, they’re also preparing for the inevitable: going back to school. It’s an exciting time for families ready to return to the comfort of a predictable routine. As part of your preparation, be sure to get your kids ready to start the school year off right by settling into a good wellness routine under these three pillars.

How payers are reimagining cost strategies with lab services: Four Becker’s roundtable takeaways

During Becker’s Spring 2024 Payer Issues Roundtable, Labcorp’s Cameron Thomason, vice president for acute care services, hospitals and health systems, and Andrew Wirsul, vice president for payer solutions, moderated a discussion among a diverse group of payer executives about the evolution of lab services. The key themes that emerged are summarized below. 

Unlocking Cell Therapy’s Full Potential by Rewiring T-Cell Metabolism

A new approach from Labcorp and Xcell Biosciences mimics the tumor microenvironment and leads to more effective T-cell populations. This published research discusses the culture conditions emulating the tumor microenvironment can be used to generate more potent cell populations. Teams at Xcell Biosciences and Labcorp used the AVATAR system to compare the performance and effectiveness of CAR T-cells grown in conventional culture conditions versus conditions more closely mirroring the tumor microenvironment. Download this research article to learn more about this breakthrough.