Review
Immunology
Vincent Dussupt, Kayvon Modjarrad, Shelly J. Krebs
Summary: The unprecedented Zika outbreak in the Americas from 2015-2016 led to global concern and accelerated the deployment of vaccine and therapeutic countermeasures. Several potent neutralizing antibodies against Zika and related flaviviruses have been discovered in recent years. Structure-based approaches have helped identify species-specific and cross-protective epitopes with therapeutic value.
FRONTIERS IN IMMUNOLOGY
(2021)
Editorial Material
Pharmacology & Pharmacy
B. Gorovits, A. Hays, D. Jani, C. Jones, C. King, A. Lundequist, J. Mora, M. Partridge, D. Pathania, S. S. Ramaswamy, D. Rutwij, H. Shen, G. Starling
Summary: EURL ECVAM recommends discontinuing the use of animals for the development of antibodies, emphasizing that EU countries should adhere to Directive 2010/63/EU and not authorize animal immunization without legitimate scientific justification. AAPS acknowledges progress in reducing animal use in drug discovery but suggests more data and discussion within the scientific community are needed before implementing non-animal derived antibodies.
Review
Biotechnology & Applied Microbiology
Harleen Kaur
Summary: Monoclonal antibodies are prone to instability issues due to their proteinaceous nature, making stability testing a critical regulatory requirement in their development and commercialization as therapeutic biological molecules. This article reviews various drug manufacturing processes and physical/chemical factors affecting stability, highlighting analytical techniques used to investigate stability studies and develop stability-indicating methods. Additionally, it discusses ICH regulatory guidelines for the stability assessment of biological products.
CRITICAL REVIEWS IN BIOTECHNOLOGY
(2021)
Editorial Material
Endocrinology & Metabolism
Cate Speake, Carla J. Greenbaum
Summary: Type 1 diabetes mellitus (T1DM) can be predicted and altered by immune therapy. The FDA's approval of teplizumab as the first disease-modifying therapy for T1DM and delaying the clinical onset of any immune-mediated disease represents a paradigm shift in the treatment of T1DM.
NATURE REVIEWS ENDOCRINOLOGY
(2023)
Review
Immunology
E. Sally Ward, Deborah Gelinas, Erwin Dreesen, Jolien Van Santbergen, Jan Terje Andersen, Nicholas J. Silvestri, Joseph E. Kiss, Darrell Sleep, Daniel J. Rader, John J. P. Kastelein, Els Louagie, Gestur Vidarsson, Isabel Spriet
Summary: Serum albumin plays important roles in maintaining homeostasis and has various functions in the body. Dysregulation of SA concentration can lead to increased risks of cardiovascular disease, hyperlipidemia, and mortality. Further understanding of the multifunctional nature of SA and its potential clinical impact is necessary.
FRONTIERS IN IMMUNOLOGY
(2022)
Article
Medicine, General & Internal
Rachel A. Bender Ignacio, Kara W. Chew, Carlee Moser, Judith S. Currier, Joseph J. Eron, Arzhang Cyrus Javan, Mark J. Giganti, Evgenia Aga, Michael Gibbs, Herve Tchouakam Kouekam, Eva Johnsson, Mark T. Esser, Keila Hoover, Gene Neytman, Matthew Newell, Eric S. Daar, William Fischer, Courtney V. Fletcher, Jonathan Z. Li, Alexander L. Greninger, Robert W. Coombs, Michael D. Hughes, Davey Smith, David Alain Wohl
Summary: These two clinical trials showed that tixagevimab and cilgavimab monoclonal antibodies were safe and effective for treating early COVID-19, but did not change the time to symptom improvement. The treatment outcomes were better for the intramuscular injection.
Review
Medical Laboratory Technology
Andrew E. O. Hughes, Ronald Jackups
Summary: This article reviews common classes of CDS tools from literature examples and institutional experience, and provides practical framework and specific recommendations for effective CDS implementation. CDS encompasses a rich set of tools that have potential for significant improvements in laboratory testing, particularly in test utilization. Deploying CDS effectively requires thoughtful design, careful maintenance, and structured processes focused on quality improvement and change management.
CLINICAL CHEMISTRY
(2022)
Review
Environmental Sciences
Tamzin A. Blewett, Kerri Lynn Ackerly, Lela S. Schlenker, Sidney Martin, Kristin M. Nielsen
Summary: Scientists are calling for greater environmental relevance in laboratory studies within the field of ecotoxicology. This article highlights key considerations when working between the lab and the field.
SCIENCE OF THE TOTAL ENVIRONMENT
(2024)
Review
Medical Laboratory Technology
Say Min Lim, Nilika Wijeratne, Kay Weng Choy, Thi Thanh Hai Nguyen, Lyana Setiawan, Tze Ping Loh
Summary: This article reviews the pathophysiology of monoclonal gammopathy (MG) and examines the laboratory testing and reporting recommendations in clinical practice guidelines. There are differences between the clinical guidelines and laboratory recommendations, with the latter providing additional diagnostic information. The assessment criteria of quality assurance programs for MG testing also vary, and greater harmonization is needed for better clinical interpretation.
CRITICAL REVIEWS IN CLINICAL LABORATORY SCIENCES
(2023)
Review
Chemistry, Multidisciplinary
Yu Chen, Ira Tandon, William Heelan, Yixin Wang, Weiping Tang, Quanyin Hu
Summary: Proteolysis Targeting Chimeras (PROTACs) have the potential to revolutionize the healthcare industry by degrading target proteins. However, inadequate delivery to the target site is one of the main challenges for PROTACs. The integration of PROTACs and delivery systems is being explored to enhance their in vivo performance.
CHEMICAL SOCIETY REVIEWS
(2022)
Article
Medicine, Research & Experimental
James Austerberry, John Edwards, Tim Eyes, Jeremy P. Derrick
Summary: The method involves using a synthetic peptide microarray to study the binding behavior of therapeutic proteins under different solution conditions. By analyzing peptide adhesion profiles, quantitative relationships between solution conditions can be established, enabling comparisons of monoclonal antibodies. Machine learning methods, such as neural networks, can be applied to train data on indicators of protein stability and self-association, providing insights into therapeutic protein formulation.
MOLECULAR PHARMACEUTICS
(2021)
Review
Pharmacology & Pharmacy
Johann Sellner, Harald H. Sitte, Paulus S. Rommer
Summary: Neuromyelitis optica spectrum disorder (NMOSD) is a rare disease of the central nervous system (CNS) with poor outcomes, and recent clinical trials have shown therapeutic benefits of IL-6 blockade. Tocilizumab and satralizumab are widely used IL-6 receptor inhibitors, successful in extending the half-life of antibodies and highlighting the potential therapeutic benefits of the emerging technology.
DRUG DISCOVERY TODAY
(2021)
Article
Oncology
Laura M. Spring, Erika Nakajima, Jennifer Hutchinson, Elene Viscosi, Gayle Blouin, Colin Weekes, Hope Rugo, Beverly Moy, Aditya Bardia
Summary: Patients with metastatic triple-negative breast cancer have a poor prognosis. Sacituzumab govitecan has shown promising therapeutic activity and received accelerated approval for the treatment of these patients. Limited information is available regarding adverse event management with this agent.
Article
Chemistry, Multidisciplinary
Angelina S. Bortoletto, W. Vallen Graham, Gabriella Trout, Alessandra Bonito-Oliva, Manija A. Kazmi, Jing Gong, Emily Weyburne, Brandy L. Houser, Thomas P. Sakmar, Ronald J. Parchem
Summary: Translation mentioned that one of the main pathological features of type 2 diabetes is the toxic accumulation of human islet amyloid polypeptide (hIAPP) aggregates. Current therapies fail to address hIAPP aggregation, while novel mAbs can serve as a diagnostic screening tool for early detection of T2D and protect beta cell function by targeting one of the underlying mechanisms of the disease.
Article
Medical Laboratory Technology
Allison Cushman-Vokoun, Josh Lauring, John Pfeifer, Damon R. Olson, Anna Berry, John Thorson, Karl Voelkerding, Jonathan Myles, James Barbeau, Pranil Chandra, Marilyn Li, Gail H. Vance, Brad W. Jensen, Molly Y. Hansen, Sophia Yohe
Summary: This article discusses the clinical and laboratory considerations regarding incidental/secondary findings in clinical tumor testing and calls for the development of guidelines in this area.
ARCHIVES OF PATHOLOGY & LABORATORY MEDICINE
(2022)