Manufacturability is access: redesigning antibody production for equitable pediatric access in LMICs
By
Kerry R. Love
Stacy E. Martin
Laura Crowell Orella
May 18, 2026
Clinical Scorecard: Enhancing Antibody Production for Improved Pediatric Access in Low- and Middle-Income Countries
At a Glance
Category Detail
Condition
Key Mechanisms Cost reduction through optimized manufacturing processes, local production, and regulatory adaptations.
Target Population
Care Setting
Key Highlights
Monoclonal antibodies are critical for treating infectious diseases in pediatric populations. Current manufacturing costs limit access to mAbs in LMICs, necessitating a target COGsM of Innovative mAbs like nirsevimab and CIS43LS show promise in preventing diseases like RSV and malaria in children. Local production and regulatory adaptations are essential for improving access to mAbs in LMICs. Cost-effectiveness of mAbs compared to vaccines is contingent on reduced pricing and local adaptability. Regional adaptability of mAbs is crucial for enhancing access in diverse healthcare settings.
Guideline-Based Recommendations
Diagnosis
Assess the need for mAb interventions in pediatric patients based on local disease prevalence.
Management
Implement regional production strategies to lower costs and improve access to mAbs.
Monitoring & Follow-up
Evaluate health outcomes and cost-effectiveness of mAb use in pediatric populations.
Risks
Consider the implications of high costs and cold-chain requirements on mAb accessibility. Assess local cold-chain capabilities to ensure mAb accessibility.
Patient & Prescribing Data
Pediatric patients in LMICs at risk for infectious diseases.
mAbs may be more cost-effective than vaccines if priced appropriately.
Clinical Best Practices
Prioritize local manufacturing to reduce costs and improve access. Engage in innovative licensing and technology transfer agreements. Adapt mAb products for regional disease variants and healthcare infrastructure. Foster partnerships with local regulatory authorities to facilitate mAb access.
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