How Monoclonal Antibodies Offer Hope for Severe Cases: DDE Supports the Development of Effective Asthma Treatments
Asthma is a chronic, non-communicable, inflammatory respiratory condition affecting more than 300 million people across the globe. It is caused by muscle tightening around the airways thereby causing bronchoconstriction and is recognized mainly by cough, dyspnoea, wheezing, breathlessness, and tightening or pain in the chest. This airway obstructive condition is presented in different phenotypes which differ in the pathogenesis, intensity, and symptoms. The increase in asthma prevalence is attributed to genetic and environmental triggering factors such as air pollution, viral infections, lifestyle etc. Asthma pathophysiology can be described as an airway inflammation that leads to airflow obstruction and hyperresponsiveness. Hyperplasia of airway smooth muscles with increased airway wall thickness and increased submucosal glands are observed over time. Asthma encircles a complex condition including several clinical and pathophysiological variants and the intensity of this condition is evident from the fact that asthmatics report poorer quality of life (than people of the same age without asthma) due to comorbidities and risk factors.
Asthma can be broadly classified into two-extrinsic asthma (allergic asthma associated with T helper type 2 (Th2) inflammation and caused mainly by various allergens such as grass pollens, pets, mites, food, etc.) and intrinsic asthma (primarily occurring due to medicines such as aspirin, viral infections, rhinitis, stress, obesity, exercise-induced bronchoconstriction etc.). Pathophysiology of the disease allows us to diversify the condition into much more precise subtyping using endotypes. In T2 asthma, allergen exposure mainly causes release of Interleukin-33(IL-33), IL-25 and thymic stromal lymphopoietin, which in turn activate Th2 cytokines (IL-4, IL-5, IL-19, IL-13). Another pathway is antigen presentation to T cells, which leads to B cell activation, mediating IgE production, eosinophilia, and activation of mast cells. Non-T2 asthma (or non-eosinophilic asthma) is an umbrella term composed of inflammatory endotypes (involving non-T2 cytokines) and noninflammatory endotypes (involving structural abnormalities, and neuroinflammation). Correct diagnosis and characterization are the critical steps in asthma management.
Asthma, being a heterogeneous condition, involves various management factors to be addressed such as risk factors, dosage of inhaled pharmacotherapy, and consideration of immunotherapeutics. Based on severity, asthma is grouped into mild, moderate, and severe. Mild and moderate asthma is mainly managed with corticosteroid inhalation, bronchodilators, and systemic glucocorticoids. Global Initiative for Asthma (GINA) advises monoclonal antibody (Mab) treatment for severe asthma cases that cannot be controlled using corticosteroids. The first biological treatment omalizumab(aimed at targeting IgE), received approvals in 2003 Mabs control airway inflammation by targeting pivotal asthma mediators of the allergic cascade such as IL-5, IL-5R, IL-13 and IL-4R. Mepolizumab(binding to IL-5), benralizumab(targeting IL-5R α), reslizumab(targeting IL-5), dupilumab(inhibiting IL-4 and IL-13 signaling) and Tezepelumab(blocking thymic stromal lymphoprotein (TSLP) are also approved by FDA as candidates for the treatment of severe asthma.
With the significant rise in respiratory diseases, DDE provides solutions to asthma management measures. DDE with its wide experience, meets the increasing demand for metered dose inhalers, dry powder inhalation, and nebulizers through designing and executing standalone and integrated process systems from pilot to production scale with Vibro Mixers, Top mounted Agitators and Bottom mounted Magnetic Mixers. Mixing/ Compounding Vessel, homogenizing vessel, Active Pharmaceutical Ingredient (API) charging ball/ Drug addition vessel Integrated suite, and Inbuilt or Standalone CIP system are our forte, a result of error free manufacturing. Immunotherapies using monoclonal antibodies are considered as revolutionary drugs that play a role in treatment of severe asthma by targeting specific inflammatory cytokines and providing patients with a chance to control the disease at bay. Many biological therapies presented as good candidates for eliciting responses may not successfully enter the commercial arena. DDE with its 4 decades of experience extends its responsibility of providing well-designed bioreactors for the synthesis of monoclonal antibodies. Through provision of scalable, error-free, safe bioprocess solutions with smart automation that meet manufacturers’ requirements and abide by regulatory requirements, we promise to ensure bench to the bed process of these drugs is a swift journey. “Asthma Education Empowers”, the theme for World Asthma Day, truly exposes patients to seek medical intervention when required and be literate about the treatment options the medical fraternity has in store with them. Though the condition cannot be completely cured, effective management improves the Quality of Life of patients and helps them to attain a social life on par with peers without Asthma. Let us help the patients by making the current treatments accessible to them through awareness of these highly effective medications and make sure we work to provide safe and efficacious medications whenever the situation demands.
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