Article
Oncology
Christopher J. Webster, Kelly L. George, Gillian R. Woollett
Summary: The principles of comparability assessments are globally accepted as sensitive and reliable tools for evaluating potential changes in biologics. Using these standards consistently for all biologics can improve market competitiveness and provide important efficiencies for regulators.
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.
Review
Immunology
Olivier Tshiani Mbaya, Philippe Mukumbayi, Sabue Mulangu
Summary: The unprecedented West Africa Ebola outbreak from 2013-2016 accelerated the development of medical countermeasures against Ebola virus disease. In the recent second-largest Ebola outbreak in the Democratic Republic of the Congo, two IPs, REGN-EB3 and mAb114, showed efficacy compared to the control arm ZMapp in an RCT. The FDA approved both medications, marking a significant advancement in EVD therapy.
FRONTIERS IN IMMUNOLOGY
(2021)
Article
Microbiology
Marina E. Kirkland, Stephanie Patfield, Anna C. Hughes, Bradley Hernlem, Xiaohua He
Summary: Shiga toxin-producing Escherichia coli infections are difficult to treat. However, a potentially therapeutic humanized mouse monoclonal antibody (Hu-mAb 2-5) targeting the most common Shiga toxin subtype has shown high neutralizing efficacy in vivo, protecting mice from mortality and HUS-related tissue damage.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2023)
Review
Biochemistry & Molecular Biology
Alexander C. Martins, Fernando Albericio, Beatriz G. de la Torre
Summary: The year 2022 saw the successful control of the COVID-19 pandemic in most countries through social and hygiene measures and vaccination campaigns. However, there was a decrease in total drug approvals by the FDA, particularly for small molecules. The Biologics class, on the other hand, maintained its figures with the authorization of 15 novel molecules.
Review
Nutrition & Dietetics
Sara Manti, Giulia Pecora, Francesca Patane, Alessandro Giallongo, Giuseppe Fabio Parisi, Maria Papale, Amelia Licari, Gian Luigi Marseglia, Salvatore Leonardi
Summary: Food allergy is a pathological immune response triggered by exposure to specific food allergens, with no specific treatment available yet. Dietary avoidance and symptomatic medications are the main treatment methods currently employed. Recent therapeutic strategies like monoclonal antibodies have shown long-term safety and benefits in clinical practice.
Review
Microbiology
Mary Garvey
Summary: This passage introduces the importance of biologics in medical research and the definition of biologics. It also describes in detail the application and advantages of eukaryotic expression systems in the production of biologics.
Review
Pharmacology & Pharmacy
Michael S. Kinch, Zachary Kraft, Tyler Schwartz
Summary: Monoclonal antibody products have become dominant in terms of revenue and patient impact, rising from obscurity in the 1990s. The remarkable advances in the discovery, development, and approval of monoclonal antibodies have contributed to this success over the past two decades. Despite industry consolidation, the number of monoclonal antibody developers continues to grow, defying the general trend in the biopharmaceutical industry.
DRUG DISCOVERY TODAY
(2023)
Review
Pharmacology & Pharmacy
Helen Prior, David O. Clarke, David Jones, Eleni Salicru, Melissa M. Schutten, Fiona Sewell
Summary: According to ICH S6 (R1), the safety evaluation of biotherapeutics usually involves two relevant species, but it can be reduced to one species for long-term toxicology studies under certain justifications. However, it is currently unclear how different companies and regulators apply these principles in practice, particularly in terms of considering the absence of toxicities.
INTERNATIONAL JOURNAL OF TOXICOLOGY
(2022)
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)
Article
Pharmacology & Pharmacy
Gangadhar Hari, Anoop Kishore, Sreedhara Ranganath Pai Karkala
Summary: Psoriasis is an autoimmune, inflammatory disorder with an unclear underlying cause. Immune cells and inflammatory cytokines are found in large amounts within the skin, contributing to inflammation. The condition has a significant impact on patients' physical and psychological well-being, with inflammation, plaque formation, and excessive keratinocyte growth being key features. Therapeutic strategies have improved with the introduction of specific therapies, and research is expanding the potential for new pharmacological targets in psoriasis treatment.
EUROPEAN JOURNAL OF PHARMACOLOGY
(2022)
Article
Allergy
Molly M. Jeffery, Jonathan W. Inselman, Jacob T. Maddux, Regina W. Lam, Nilay D. Shah, Matthew A. Rank
Summary: The study found that the likelihood of an increase in asthma exacerbation rate in patients who stopped using asthma biologics was similar to those who continued using biologics.
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE
(2021)
Article
Microbiology
Jessica Tan, Veronika Chromikova, George O'Dell, Emilia Mia Sordillo, Viviana Simon, Harm van Bakel, Florian Krammer, Meagan McMahon
Summary: The global health burden of influenza B viruses, especially in children, has been underestimated for a long time. Current vaccines and antivirals have limitations in dealing with influenza B viruses. The potential of broad antineuraminidase antibodies as therapeutics to prevent and treat infections caused by influenza B viruses is demonstrated in this study. Intranasal administration shows promise as an alternative route for antibody therapeutics.
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
Medicine, General & Internal
Sara Manti, Alessandro Giallongo, Maria Papale, Giuseppe Fabio Parisi, Salvatore Leonardi
Summary: Omalizumab remains the best choice for treating refractory CSU, but some patients remain unresponsive. Other mAbs targeting different pathways have shown promising results, but further RCTs are needed to confirm their effectiveness and safety.
JOURNAL OF CLINICAL MEDICINE
(2022)
Article
Medicine, Legal
Fiona Sewell, Ian Ragan, Graham Horgan, David Andrew, Thomas Holmes, Irene Manou, Boris P. Mueller, Tim Rowan, Barbara G. Schmitt, Marco Corvaro
Summary: There are currently three test guidelines for acute oral toxicity studies, but the subjectivity of one guideline may be hindering its wider use. In order to address this, the NC3Rs and EPAA collaborated to analyze historical data and provide recommendations on the recognition of 'evident toxicity'.
REGULATORY TOXICOLOGY AND PHARMACOLOGY
(2024)
Article
Medicine, Legal
Michael DeVito, Bas Bokkers, Majorie B. M. van Duursen, Karin van Ede, Mark Feeley, Elsa Antunes Fernandes Gaspar, Laurie Haws, Sean Kennedy, Richard E. Peterson, Ron Hoogenboom, Keiko Nohara, Kim Petersen, Cynthia Rider, Martin Rose, Stephen Safe, Dieter Schrenk, Matthew W. Wheeler, Daniele S. Wikoff, Bin Zhao, Martin van den Berg
Summary: In October 2022, the World Health Organization reevaluated the toxic equivalency factors (TEFs) for chlorinated dioxin-like compounds in a panel convened in Lisbon. This effort utilized an updated database, Bayesian dose response modeling, and meta-analysis to derive Best-Estimate TEFs. Applying these new TEFs may result in lower total toxic equivalents for dioxin-like chemicals.
REGULATORY TOXICOLOGY AND PHARMACOLOGY
(2024)