Otsuka
Establishing Cold Chain Robustness for Otsuka’s Sibeprenlimab PFS: A Shipping Validation Study
Challenge
Otsuka, a global healthcare company, developed sibeprenlimab, an investigational monoclonal antibody for treating Immunoglobulin A (IgA) nephropathy. As the therapy advanced toward commercialization, Otsuka needed to validate its global supply chain to ensure the product’s integrity throughout shipment and storage.
The project presented several challenges, including managing temperature-sensitive distribution across multiple global lanes, demonstrating packaging robustness under variable conditions, and meeting stringent regulatory requirements for a pre-filled syringe (PFS) configuration.
To address these complexities, Otsuka required a partner with deep expertise in cold chain engineering, transport validation, and regulatory alignment—one capable of delivering a comprehensive, risk-based validation strategy for global submission.
Objectives
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Map supply chain conditions and define transport requirements.
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Conduct a risk assessment to identify and mitigate potential transport hazards.
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Develop a Validation Master Plan detailing strategy, scope, and approach.
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Execute risk-based transport qualification and simulated distribution studies.
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Select and qualify active and passive thermal packaging solutions.
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Oversee performance qualification (PQ) studies and compile validation reports.
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Support global and FDA submissions with regulatory-ready documentation.
Results
In November 2025, the FDA granted accelerated approval for sibeprenlimab, now marketed as Voyxact, as the first treatment of its kind for IgA nephropathy. Read the full case study to see how Modality Solutions created a risk-driven validation strategy to help enable global distribution readiness for a first-in-class therapy.
Download the full case study