Monoclonal antibodies (mAbs) are used to prevent, detect, and treat a broad spectrum of non-communicable and communicable diseases. Over the past few years, the market for mAbs has grown exponentially with an expected compound annual growth rate (CAGR) of 11.07% from 2024 (237.64 billion USD estimated at the end of 2023) to 2033 (679.03 billion USD expected by the end of 2033). Ever since the advent of hybridoma technology introduced in 1975, antibody-based therapeutics were realized using murine antibodies which further progressed into humanized and fully human antibodies, reducing the risk of immunogenicity. Some benefits of using mAbs over conventional drugs include a drastic reduction in the chances of adverse reactions, interactions between drugs, and targeting specific proteins. While antibodies are very efficient, their higher production costs impede the process of commercialization. However, their cost factor has been improved by developing biosimilar antibodies as affordable versions of therapeutic antibodies. Along with the recent advancements and innovations in antibody engineering have helped and will furtherly help to design bio-better antibodies with improved efficacy than the conventional ones. These novel mAb-based therapeutics are set to revolutionize existing drug therapies targeting a wide spectrum of diseases, thereby meeting several unmet medical needs. This review provides comprehensive insights into the current fundamental landscape of mAbs development and applications and the key factors influencing the future projections, advancement, and incorporation of such promising immunotherapeutic candidates as a confrontation approach against a wide list of diseases, with a rationalistic mentioning of any limitations facing this field.
Antibodies are one of the naturally existing and primary pathways through which the body defends itself against antigens, which may be derived from bacteria, viruses, fungi, parasites, bacterial/virus-infected cells, pollen, or nonliving substances, such as toxins, chemicals, drugs, or foreign particles considered alien to the body as epitopes expressed on cancer cells, etc. Specific binding to their targets is consequenced by either neutralizing and interfering with their pathogenic effect or flagging them for clearance or destruction as one of the Ag-Ab immune-complex fates. Antibodies are considered one of the most prominent and promising remarks in the medicinal, pharmaceutical, and even veterinary fields, with a wide range of significant diseases’ prophylactic, therapeutic, and diagnostic approaches, on the cusp of the modern medicine era.
In this context, this review aims to comprehensively: (1) highlight the fundamentals of mAbs-development and optimization technologies, (2) focus on the wide range of current therapeutic applications of mAbs in non-communicable diseases, (3) shed light on the ongoing development of mAbs-dependent antimicrobials for communicable diseases, (4) clearly describe the limitations and possible adverse reactions associated with the use of mAbs, and (5) in a prospective manner mentioning prospective insights on incorporating artificial intelligence (AI) to accelerate and redirect mAbs development and applications.
This review comprehensively presented an overall view of the background, fundamentals, and future of mAbs development platforms, techniques, and technologies with a deep and wide glimpse of the mAbs therapeutic applications either in both infectious and noninfectious diseases. In this context, mAbs can potentially provide more effective and safer treatment options than traditional therapies. In a world of antibiotic-resistant superbugs and an aging population grappling with autoimmune disorders and cancer, mAbs offer the potential for new, targeted treatments and drugs that can provide personalized care, and a window into the complex, overlapping conditions that underlie human disease.
Despite the tremendous progress in developing new mAbs with a wide range of developmental technologies and the significant advantages that have been achieved using previously developed mAbs in the field of medicine that have revolutionized the treatment of various diseases, there are still many obstacles to overcome in every step of the developing process, as well as clinical and market challenges that make them commercially less attractive which includes the high cost of production, and administration challenges may hinder their widespread accessibility, immunogenicity, and limited target range are additional considerations that need to be addressed to optimize their effectiveness.
Enhancing mAb formulations in terms of dose, distribution, and stability is a continuous challenge. Improvement of these Abs' PK and PD is also necessary. It's important to comprehend how mAbs work in concert with other medications or therapies and the best ABD combinations for different medical conditions. The mechanisms of action of mAbs require further research, particularly in complex illness settings. The development of AI- and machine learning (ML)-based models that can be utilized to further optimize the molecular architectures of protective Ab molecules is hindered by the scarcity of experimentally confirmed data. More sophisticated machine learning models and algorithms must be developed to improve prediction. Next-generation mAb production is expensive and time-consuming. It demands appropriate, scalable, cost-effective cell line production and procedures, as well as efficient expression and purification platforms
Many efforts are required to overcome these challenges, including advancing more potent mAbs, development of new formulation and delivery methods, efficient clinical trials that include mAb combinations, and engagement with organizations operating in low- and middle-income countries to favor technology transfer and access to these new bioproducts.
The ability to engineer these molecules to improve their properties and target intracellular compartments, bind two different antigens simultaneously, deliver drug conjugates, and generate Fc fusions revolutionized the treatment of diseases. Out of more than 100 currently approved mAbs, 6 were approved in the 1990s, 16 from 2000 to 2010, 70 from 2011 to 2020, and 32 in the past three years (2021–2023), thus showing an upward growth in the production and marketing authorization of therapeutic mAbs. Also, AI has the potential to accelerate mAb development, enhance production processes, improve therapeutic efficacy, and enable personalized medicine approaches. However, it's important to note that while AI can provide valuable insights and predictions, experimental validation and human expertise remain crucial for successful mAb synthesis and application. Finally, mAbs are providing a promising alternative and strategic therapeutic panel that grows day after day.
For more interesting updated details about mAbs, their developing techniques, and their wide range of applications in communicable and non-communicable diseases, visit our open access article on Molecular Biomedicine at the following link; https://link.springer.com/article/10.1186/s43556-024-00210-1#Sec58
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