A Laboratory Developed Serum Anti-Mullerian Hormone Electrochemiluminescent Immunoassay: Performance and Retrospective Analysis of Over 2.2 Million Tests in Females and Males Across Lifespan

Authors:  D. Alfego, C. Cheng, M. Bastidas, B. Bauer, K. Chun

4T1-luc2: An orthotopic mammary cancer model to support novel immuno-oncology drug discovery

Breast cancer is the second most deadly malignancy after lung cancer in woman in the United States, with an estimated 246,000 new cases and 40,450 deaths expected in 2016. Many treatment options for breast cancer exist including surgery, radiotherapy, anti-estrogen therapy, targeted therapies (e.g., trastuzumab), and chemotherapy. Despite these therapeutic advances, metastatic disease remains a significant source of mortality. Immunotherapy has seen remarkable progress in the last five years with four T cell immune checkpoint inhibitors approved. While none of these checkpoint inhibitors are approved in breast cancer, there are currently 60+ clinical trials ongoing in breast cancer with checkpoint inhibitors against PD-1 or PD-L1 and 20+ clinical trials ongoing with CTLA-4 inhibitors. 

Labcorp Expands Collaboration with Ultima Genomics to Advance Whole Genome Sequencing Applications and Oncology Testing Capabilities

BURLINGTON, N.C. , and FREMONT, Calif. , July 29, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced an expanded collaboration with Ultima Genomics to utilize its UG 100 TM sequencing solution and ppmSeq TM technology to

Melissa Usher

Melissa joined Labcorp in April of 2024 as the Quality Director of the West Division. After serving as a Medical Lab Technician in the U.S. Navy, she spent over 20 years in pharmaceutical, medical device, and biologics manufacturing. She has a wide variety of experience, having worked in laboratory, individual contributor, management, and leadership roles across Quality Control and Quality Assurance functions. She also has experience with Lean Enterprise, participating in and facilitating methodologies such as kaizen, kanban, and 5S.

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.