"Monoclonal Antibodies as Promising Therapeutic Agents in the Pharmaceutical Industry and Their Current Challenges" by Alara Ozen

 Objectives:

Objective 1: Assessment of the progression of monoclonal antibody generation over time to provide better quality, safety, and efficiency of the product and advance its therapeutic use.

Objective 2: Identification of the current challenges in the development and therapeutic use of monoclonal antibody therapeutics.

Objective 3: Analysis of the therapeutic use and challenges of monoclonal antibodies from different perspectives of professionals.

Objective 4: Evaluation of the potential of monoclonal antibodies for the treatment of recently emerged COVID-19 pandemic.

Methodology:

As the therapeutic use and potential of monoclonal antibodies, especially for recently emerged diseases, is brand-new technology and the uncertainties are ongoing, the philosophy of critical realism is considered. Additionally, positivism was deemed appropriate due to being a scientific field. As the determination of the challenges would be the first step of the problem-solving process, the research is additionally influenced by pragmatism. A blended form of induction and abduction approaches is followed. Both quantitative and qualitative data were gathered, and survey and archival research strategies were followed in a cross-sectional time horizon.
 
Findings:

The pharmaceutical industry has seen a massive improvement in the market value with the discovery of monoclonal antibodies and so did the advancements in the generation of human-like antibody types. The number of approved monoclonal antibodies has increased 4 times in the second half of the last ten years compared to its first half. Drug design and formulation as a challenge in the development of monoclonal antibodies received the highest percentage of 81% among other factors. The following two concerns were the biodistribution of the molecule with 75% agreement, and undesirable by-products generated during manufacture and processing with 71% agreement. Related to their therapeutic use, high costs bring a major challenge for patient access. There are also safety concerns stated by some professionals. Despite current bottlenecks; professionals overall believe monoclonal antibodies are promising for the future due to their positive impact on current diseases with no cure, including COVID-19.

Analysis:

The monoclonal antibody therapeutics have rapidly grown due to patient needs. The statistics of the approved monoclonal antibodies in the last 10 years show that it will continue to grow even much faster. The challenging factors in the development of monoclonal antibody therapeutics indicate that there are still gaps in molecular attributes, therefore more R&D studies in the field are needed. Complex manufacturing procedure brings difficulties in the prediction of the molecules. The studies on the biosimilar alternatives and implementation of high-volume manufacturing technologies should be fostered to reduce costs. This technology will also help to decrease biocontamination risks, which answers the challenge of undesired by-products during the manufacturing of monoclonal antibodies. The significant percentage of respondents being in favor that monoclonal antibodies will grow in the future is a great indication that challenges are achievable and will not prevent the growth of monoclonal antibody therapeutics.

Conclusions:

Monoclonal antibodies have an extraordinary potential to shape the future of the pharmaceutical industry. The advancements in the formulation of monoclonal antibodies and the implementation of genetic engineering techniques are likely to reduce the safety risks while increasing efficiency and quality. These efforts to generate more human-like or effective monoclonal antibodies also improved the quality of the product. However, current technology has not been improved enough to perform a standardized mass manufacturing of monoclonal antibodies, resulting in high costs in the production which also reflects patients’ access. Regulatory differences between countries is another challenge that limits the global pharmacovigilance knowledge of certain products and prolongs the time needed for the approval procedure. Nevertheless, considering the benefits of monoclonal antibodies to human health, as well as their influential aspects within the pharmaceutical market profiles, and the rich product pipeline they provide, monoclonal antibodies are well worth investing in.