Advanced therapy products, including autologous and allogeneic cell and gene therapies (CGT), present significant opportunities alongside substantial operational challenges. Among the most critical of these challenges is managing temperature-sensitive biologics throughout the CGT cold chain process. Effective cold chain management ensures patient safety, regulatory compliance, and the viability of therapies.
While much attention is paid to packaging, transportation, and temperature monitoring, precise scheduling is often overlooked as an essential factor in cold chain integrity. Binocs™, our resource planning and scheduling tool tailored specifically for CGT production and QC workflows, addresses this challenge by coordinating patient collections, resource allocation, and capacity management to reduce cold chain risks proactively.
Let’s explore five critical ways that Binocs supports CGT cold chain integrity.
Binocs provides highly accurate slot scheduling capabilities, coordinating patient sample collections, QC testing, and manufacturing timelines.
Extended storage increases the risk of product degradation and regulatory non-compliance.
Using AI-driven algorithms, Binocs schedules critical steps such as tissue receipt, QC release, and batch fill-finish with precise timing, minimizing unnecessary storage time and maintaining strict adherence to validated temperature windows.
Binocs continuously refines turnaround-time forecasts based on real-world performance data.
Variability increases complexity, requiring larger buffers of cold storage capacity, raising costs, and amplifying risk.
Binocs dynamically integrates performance feedback, improving scheduling reliability and reducing dependency on costly and risky cold storage buffers.
Binocs integrates with Chain of Identity (COI) / Chain of Custody (COC) platforms such as TrackCel Ocellos and SAP CGTO.
Accurate alignment between patient tissue collection and manufacturing/testing availability is crucial to maintaining product viability.
Binocs provides real-time visibility into production and testing slot availability, ensuring patient tissue collections occur precisely within optimal time windows that match manufacturing schedules.
Binocs schedules the availability and maintenance of critical equipment, including biosafety cabinets and cryogenic storage tanks.
Equipment bottlenecks can lead to delays, compromising product integrity by prolonging exposure to suboptimal temperatures.
By managing equipment scheduling alongside personnel and process dependencies, Binocs proactively prevents equipment conflicts, ensuring smooth transitions and reducing cold chain exposure.
Binocs provides real-time, cross-functional visibility into emerging delays across CGT processes.
Unrecognized delays can propagate quickly, causing widespread disruption to the cold chain and risking product compliance and viability.
Real-time dashboards and predictive alerts from Binocs allow teams to quickly identify potential delays and proactively reassign resources or adjust sequences, maintaining continuity and minimizing cold chain risk.
Effective cold chain risk management in cell and gene therapy begins well before shipping or transport—it begins with precise and reliable scheduling. Binocs supports this critical need by embedding scheduling accuracy into every stage of the production, testing, and delivery process. By minimizing idle time, reducing variability, ensuring equipment availability, and providing proactive delay management, Binocs strengthens cold chain integrity, regulatory compliance, and patient safety.
Through accurate and integrated scheduling, Binocs provides CGT manufacturers with a foundational solution to maintain product integrity at every step.
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