Securecell Unveils APIES Multi-Attribute Analysis Platform for Biopharmaceuticals: Real-time Monitoring of Protein Concentration, Aggregation, and Stability

July 5, 2026

Securecell Switzerland

Overview

Securecell has launched APIES, a multi-attribute analysis platform providing comprehensive insights into biopharmaceutical samples. APIES leverages absorbance, intrinsic fluorescence, and scattering to enable real-time or near real-time monitoring of protein concentration, aggregation, stability, and kinetics. This significantly supports Process Analytical Technology (PAT) and Quality by Design (QbD) strategies in bioprocess development, drastically improving product quality and process efficiency.

In Depth

Key Findings

Securecell has introduced APIES, an innovative multi-attribute analysis platform that enables comprehensive characterization of biopharmaceutical samples. By utilizing three physical measurements—absorbance, intrinsic fluorescence, and scattering—this platform facilitates real-time or near real-time monitoring of multiple critical quality attributes (CQAs), including protein concentration, aggregation state, stability, and reaction kinetics. The adoption of APIES profoundly supports Process Analytical Technology (PAT) and Quality by Design (QbD) strategies in bioprocess development, dramatically enhancing product development efficiency and reliability.

Technical and Clinical Details

The APIES platform integrates multiple physico-optical methods into a single, cohesive system, allowing for a multifaceted evaluation of the complex characteristics of biopharmaceuticals. Absorbance is used to quantify the concentration of molecules like proteins and nucleic acids. Intrinsic fluorescence (e.g., autofluorescence from tryptophan residues) provides information about protein conformational changes and stability, capable of detecting denaturation due to thermal or chemical stress. Scattering (e.g., Rayleigh scattering, Mie scattering) is particularly effective for assessing protein aggregation and particle size distribution, enabling early detection of sub-micron to micron-sized aggregate formation. These measurements can be performed inline or at-line without sample pretreatment, allowing for rapid feedback loops to identify and correct process deviations in real-time. APIES is compatible with samples at various stages, including solutions sampled directly from bioreactors, purification intermediates, and final products. This ensures consistent quality monitoring throughout development and manufacturing, making it easier to maintain desired quality profiles.

Background and Industry Context

Biopharmaceutical development and manufacturing are highly complex and costly processes, demanding stringent quality control to ensure product safety and efficacy. Traditional quality control methods have relied on manual, offline analyses, which are time-consuming and labor-intensive, making real-time process control difficult. This limits opportunities for early detection and correction of process changes. Regulatory bodies like the FDA and EMA encourage the adoption of Quality by Design (QbD), meaning that product quality is built into the manufacturing process. PAT is a crucial component of QbD, providing tools to understand and control processes in real-time. A multi-attribute analysis platform like APIES offers essential technological infrastructure for effectively implementing PAT strategies, thereby reducing risks and improving efficiency in biopharmaceutical development.

Strategic Significance and Outlook

The advent of multi-attribute analysis platforms like APIES holds the potential to significantly transform the future of biopharmaceutical development. Future advancements are expected to extend the analytical capabilities of the platform to monitor an even broader range of CQAs in real-time. Integration with AI and machine learning will enhance the ability to extract insights from complex multivariate data, leading to predictive process control and self-optimizing bioprocesses. This will shorten development cycles and accelerate time-to-market. Furthermore, seamless integration into continuous manufacturing processes will enable end-to-end quality control, which is expected to further reduce biopharmaceutical manufacturing costs and improve therapeutic accessibility. APIES will establish new standards in biopharmaceutical quality and efficiency, serving as a critical tool for driving industry innovation.

Source: https://www.securecell.ch/insights/apies-biopharmaceutical-analysis-alan-ryder?hsLang=en

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