Choosing the Right Automated Immunoassay Platform for Your Analytical Needs

Automated immunoassay platforms have transformed the way laboratories handle analytical testing in bioprocess development and manufacturing. By replacing time-intensive manual steps with streamlined automation, these systems enable faster turnaround times, greater accuracy, and reduced variability. But selecting the right platform requires careful consideration. Here, we break down the key factors that can help you make the best choice for your lab while keeping scalability, cost, and efficiency at the forefront.

Open or Closed Platform? Understanding Your Options

One of the first decisions to make is whether an open or closed immunoassay platform works better for your operational needs. Each system type offers distinct advantages and is tailored for specific workflows.

Benefits of Closed Platforms

A closed platform typically integrates pre-validated kits and reagents designed specifically for the system. Because these systems are pre-optimized, they deliver:

• Reduced variability between runs and across users.
• Simplified protocols, making advanced workflows accessible without the need for frequent manual adjustments.
• Enhanced reproducibility, especially crucial when transferring data between global teams or meeting regulatory standards.

Closed systems offer dependable consistency, making them ideal for labs with strict standardization or those working across multiple locations.

Flexibility of Open Platforms

Open platforms, in contrast, provide unparalleled adaptability. These systems allow you to customize workflows, use reagents from multiple suppliers, and scale assays as needed. Key advantages include:

• Greater control over reagents, enabling cost-effective choices without compromising sensitivity.
• Adaptability to changing project demands, such as new assay formats or regulatory updates.
• Long-term scalability, essential for labs in dynamic fields like drug discovery and biomanufacturing.

By empowering researchers to modify their processes, open platforms facilitate innovation and ensure your methods stay ahead of evolving requirements.

Scalability from Discovery to Quality Control

A versatile platform that supports the entire drug development lifecycle — from discovery to QC — offers significant benefits for cross-departmental collaboration. With a unified system, teams experience:

• Streamlined data sharing, contributing to better communication across processes.
• Standardized infrastructure, reducing operational redundancy.
• Improved coordination, allowing both upstream and downstream teams to align more efficiently.

Scalability ensures you can adapt your systems as projects move from exploratory phases to regulatory submissions, providing continuity and reliability regardless of your team’s focus.

Ensuring Regulatory Compliance with CFR 21 Part 11

If you anticipate using your platform for regulatory filings, it’s crucial to ensure its software complies with CFR 21 Part 11. Non-compliant systems may suffice for exploratory data, but for submission-critical phases, compliance guarantees:

• Data integrity, ensuring your findings are robust and secure.
• Traceability, with a clear audit trail across workflows.
• Regulatory confidence, crucial for advancing through clinical and approval stages.

Regulatory-friendly systems lend credibility to your data and support your lab’s long-term success in meeting industry standards.

Key Takeaway

Selecting the right automated immunoassay platform requires balancing flexibility, precision, and scalability. Closed platforms deliver standardization and consistency, while open systems champion adaptability and innovation. Scalability across development stages, and regulatory compliance further define a system’s capabilities to enhance your bioprocess workflows.

With automation, you can reduce manual workloads, improve reproducibility, and ultimately make faster, better-informed decisions for your projects. By understanding your unique lab requirements and matching them to the strengths of an immunoassay platform, your team gains the tools needed to innovate with confidence.

Are you ready to simplify workflows while scaling results? By focusing on the right factors, the perfect immunoassay platform for your needs could be just a step away.