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In vitro diagnostics (IVDs) have a crucial function in modern healthcare, enabling precise detection and tracking of diseases through the analysis of biological samples. IVD manufacturing involves several key steps and bringing an IVD from concept to market is a complex process that requires careful planning, validation, and regulatory approval.
This overview outlines the essential stages and key considerations in IVD manufacturing, providing a high-level map from initial assay concept through post-market surveillance. To maintain conciseness, it does not consider broader regulatory requirements, delve deeply into assay development, provide details on validation and verification, etc. The goal is to reveal insights into the steps that are directly relevant to manufacturing and operations, regardless of whether the manufacturing is performed in-house or with contract IVD manufacturing service providers.
Following initial concepting, a crucial next decision is selecting raw materials. While it may be tempting to utilize lowest cost materials, there are a number of factors that should influence your decision, with an emphasis on material reproducibility. These include:
During assay development you will establish baseline sensitivity, specificity, optimize reagent concentrations and reaction conditions, and perform guard band studies- among many other criteria. There are two key steps that rely on manufacturing:
Optimize reagent concentrations and reaction conditions for performance and stability: It is critical that the reagent formulations are reproducible and stable across production scales to maintain performance in mass IVD manufacturing. Early in assay development, test different lots or batches of key components.
Perform stability testing on critical reagents: Test reagents under different storage conditions to ensure they remain effective over the assay’s planned shelf life.
It is common for assays to be first designed with “wet components” or “liquid formulations” and then shifted to components compatible with lyophilization. Lyophilization provides reagent stability and enhance shelf-life, while removing cold-chain logistics.
As the assay is refined and comes together, key considerations are how it will be packaged, shipped, and stored.
Selection of materials for temperature-sensitive reagents: For cold chain logistics use materials that provide insulation and protection, such as double-walled packaging.
Determine ideal storage conditions for each reagent: Establish specific storage parameters (temperature, light, humidity) based on the reagent’s sensitivity to ensure maximum stability.
Design temperature-controlled logistics solutions: If reagents require strict temperature control, to maintain integrity it might be required to implement refrigerated or frozen transport options. Using temperature sensors or indicators within packaging will help track and record conditions throughout transport.
Optimize for ease of use in end-user environments: Design packaging that is both user-friendly, sustainable and provides simple and safe reagent handling in labs or point-of-care settings.
Label with clear storage and handling instructions: Clearly mark packaging with storage guidelines and warnings for temperature or light sensitivity to help users maintain product stability.
Prepare for regulatory audits: Keep thorough records of packaging and storage processes to meet FDA, ISO, and other relevant regulatory standards during inspections.
For either in-house manufacturing, or using IVD contract manufacturing services, the same key steps apply as the assay moves from engineering batches to full-scale production.
IVD kits are commonly shipped with outer packaging that protect the contents during transportation and handling. IVD manufacturing must also deal with storage and distribution.
Develop shelf-ready packaging for easy handling: Design packaging that is ready for direct placement on shelves in distribution centers and end-user facilities. Consider weights and package dimensions that fit easily within air or truck freight specifications, to avoid specialized and costly handling.
Optimize inventory levels based on demand forecasts: Plan inventory levels strategically to prevent stockouts or overstock, using demand data and predictive analytics for more accurate forecasting. Adjust logistics to account for local regulatory requirements, customs, and import/export documentation in each target region.
Document packaging and distribution processes: Keep thorough records for each packaging configuration and distribution route to ensure regulatory compliance and facilitate inspections. Include detailed instructions on packaging to guide handlers and users on correct storage and handling procedures.
IVD manufacturing of regulated products fall under a number of complex requirements and compliance is required.
IVD manufacturing teams play essential roles in product performance, even after products are delivered.
Monitor product performance: Continuous monitoring and reporting of any issues, which is critical for post-market surveillance.
Feedback and improvements: Provide customer support and gather customer feedback to maintain product quality and safety, as a part of a robust QMS. Ensure that recall handling is a smooth and efficient process.
CAPA and adverse event reporting: Use automated tools to more effectively report to regulatory bodies by identifying any unfavorable events. Create a strong CAPA procedure to ensure that corrective actions are thoroughly recorded, traceable, and informed to all relevant parties.
IVD manufacturing is complex as it spans multiple disciplines, is highly regulated, and consists of numerous steps. Key IVD manufacturing steps are not necessarily sequential. The manufacturing process must be considered very early in assay development, when the product is still in concept phase, or else teams risk developing a great assay that has high costs or one that cannot actually be produced at scale. Even if it can be manufactured, without proper development the IVD product may be unstable during storage. If the IVD packaging is burdensome to use, even an excellent assay might suffer poor market adoption. One of the most essential steps in IVD manufacturing is the transfer from the assay development team to the manufacturing team, and experienced specialists in this step can make or break a project. Finally, IVD manufacturing does not end when the product is shipped as it plays a critical role in post-market surveillance.
Argonaut is FDA inspected and supports a wide range of products under 21 CFR 820.
With ISO13485:2016 and cGMP, Argonaut adheres to the highest quality standards, ensuring compliance and reliability.
With decades of experience in IVD manufacturing, Argonaut’s team of experts offers guidance at every stage of product development and commercialization.
Argonaut is a recognized leader in lyophilization with a wide service selection including cakes, LyoDose beads, and LyoDots™.
From hand-filling for precision needs to robotic systems for large-scale production as demand grows, Argonaut provides flexible solutions for a number of formats.
Argonaut has a robust quality systems and redundancy in supply chains, guaranteeing continuity and reliability even during global disruptions.
From pre-launch engineering builds to flexible on-demand production, Argonaut manufacture in all commercial phases.
Leveraging advanced logistics solutions, Argonaut ensures secure, compliant, and efficient packaging and global shipping for temperature-sensitive IVD products.
