Mpox: A Global Health Crisis Requiring Urgent Therapeutic Innovations and Scalable Solutions

Amid global efforts to combat the Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) pandemic, a novel viral threat, Mpox, formerly referred to as Monkeypox has emerged within the human population. Mpox — an infectious disease caused by the Monkeypox virus — is categorized into two distinct clades: Clade I (with subclades Ia and Ib) and Clade II (with subclades IIa and IIb). A significant global outbreak, attributed to the Clade IIb strain, occurred between 2022 and 2023, leading the World Health Organization (WHO) to classify Mpox as a public health emergency. Affecting multiple regions, the resurgence of Mpox, particularly in the Democratic Republic of the Congo and other African countries due to Clades Ia and Ib, has intensified global concerns. In August 2024, the WHO once again declared Mpox a global public health emergency following the emergence of a more virulent Clade Ib strain, which has now expanded beyond Africa. In September 2024, India confirmed its first case of the Clade I variant, heightening the sense of urgency surrounding this evolving threat.

Mpox primarily transmits among monkeys, Gambian pouched rats, and squirrels, but it can sporadically jump to humans, leading to localized outbreaks. Zoonotic transmission occurs through contact with infected animals via bites, scratches, or activities such as hunting, skinning, and handling. Human-to-human transmission predominantly arises from close interpersonal contact, particularly within households. Additionally, the virus may spread through contaminated objects such as clothing and linens, needle-stick injuries in healthcare settings, or vertical transmission during pregnancy or childbirth. 

The clinical presentation of Mpox typically encompasses several symptoms, including a characteristic rash, fever, pharyngitis, sore throat, headache, muscle aches, back pain, and lymphadenopathy. The treatment of Mpox is primarily centered on symptomatic relief, as most cases are self-limiting. Supportive care, including analgesia, antipyretics, and fluid maintenance, forms the foundation of management. In severe cases or individuals with heightened vulnerability, such as immunocompromised patients, or those exhibiting severe disease or complications, antiviral therapies are indicated. Furthermore, stringent infection control protocols are critical to mitigating transmission.

The global discontinuation of smallpox vaccination has shown a decline in the proportion of individuals possessing cross-immunity against the Mpox virus. Although the Mpox virus is categorized within the DNA virus family, it exhibits markedly elevated genomic variability, attributable to heightened nucleotide polymorphism. The surge in global population mobility and the escalation of international travel have further facilitated the pervasive dissemination of the Mpox virus among diverse populations, augmenting its potential for mutation and contributing to increased genetic variability, drug resistance, and the emergence of multidrug-resistant strains.

Considering the continual evolution of Mpox variants, researchers are actively investigating novel drug targets and therapeutic modalities for treating this infection. Monoclonal antibodies (mAbs) have demonstrated promising effectiveness in treating Mpox in preclinical studies and early clinical investigations. Designed to bind to viral proteins specifically, mAbs inhibit the virus' ability to infect host cells, which enhances their efficacy compared to broader antiviral treatments. Although comprehensive clinical trial data specific to Mpox mAbs is still emerging, the efficacy observed in related viral infections, such as the vaccinia virus, supports optimism regarding their effectiveness against Mpox. However, extensive clinical trials are required to fully establish their efficacy and safety in human populations. Challenges such as the emergence of viral escape variants and the need for early administration underscore the importance of prompt diagnosis and treatment.

As the field advances, mAbs are poised to play a pivotal role in managing Mpox and other Orthopoxvirus infections. To realize their full therapeutic potential, it is essential to integrate innovative solutions and specialized expertise to establish a streamlined, scalable platform for production. DDE offers a robust portfolio of safe, effective solutions, helping manufacturers meet stringent regulatory standards that ensure the consistency, purity, and efficacy of their final products. Our cutting-edge aseptically processing bioreactors are engineered to streamline manufacturing workflows, boost operational efficiency, and expedite bioburden-free biologics while ensuring full compliance with global regulatory standards such as FDA , EMA, World Health Organization (WHO) , and cGMP. DDE’s adaptable, highly versatile, and modular systems are engineered to accommodate the evolving advancements within the biopharmaceutical landscape, facilitating hassle-free transitions between production processes. This design ensures rapid responsiveness to pandemic-like scenarios, enabling more efficient and timely interventions.

DDE's bioreactor portfolio, ranging from 10L to 150 KL, is engineered for optimal cell growth and expression, featuring advanced aeration systems that deliver ideal bubble size, increased residence time, and enhanced gas dissolution in media. Uniform mixing, free of dead zones, ensures maximized media utilization, while low-shear impellers and an optimized agitation system prevent cell damage, supporting superior cell expansion. Integrated Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) capabilities, along with customizable Sterilization In Place (SIP) options, ensure aseptic conditions throughout bioprocesses. DDE’s bioreactors are energy-efficient, minimizing utility consumption without sacrificing performance. Automation systems comply with stringent regulatory standards, including those of the USFDA, and the PLC (Programmable Logic Controllers) ∕PCS (Process Control System)/DCS (Distributed Control System)/ SCADA (Supervisory Control and Data Acquisition)/OPC (Open Platform Communications)-driven platforms provide remote connectivity and redundancy. Fully user-configurable, upgradeable software ensures flexibility, while batch management systems with eBMR recipe documentation offer an ideal solution for comprehensive record-keeping and regulatory compliance.

The ongoing Mpox outbreak is the most extensive in the virus’s history, heightening concerns about a potential global public health threat. DDE recognizes that expediting the development of effective anti-Mpox therapies is critical to addressing future challenges and ensuring more robust protection for global health. With a comprehensive grasp of technological advancements, DDE continuously refines its bioprocessing solutions to lead in the production of innovative therapeutics. Leveraging cutting-edge Process Analytical Technology (PAT) and a robust Quality by Design (QbD) approach, DDE ensures scalable, consistent product quality. Its automated, closed-system solutions are pivotal for enhancing the safety and efficacy of large-scale monoclonal antibody (mAbs) production, driving both efficiency and regulatory adherence. DDE is committed to accelerating the development of effective anti-Mpox therapies, a critical step in strengthening global health defenses.