Raising the Bar: Advancements in HPLC Calibration for Biopharmaceuticals
The biopharmaceutical industry is continuously evolving with new developments in technology, research, and methodologies. One critical aspect of biopharmaceutical production is High-Performance Liquid Chromatography (HPLC), a powerful analytical tool used for the separation, identification, and quantification of various components in complex mixtures. Over the recent years, HPLC calibration has made significant advancements that have increased the accuracy and reliability of this analytical method.
Latest Advancements in HPLC Calibration
Improved Column Technology
A signficant advancement in HPLC calibration has been the development of new column technologies. With the introduction of sub-2-micron particle sizes and core-shell particle column, has increased the efficiency of HPLC separations. These have provided higher resolution and improved peak capacity, making results more accurate and reproducible. With the use of monolithic columns, this has enhanced the separation of biomolecules providing stability and resistance to high pressures.
Automation and Software Improvements
With today's HPLC systems, they now incorporate advanced automation features that greatly improve calibration and data processing. Automated sample injection and column switching systems have reduced manual errors. Advanced software packages enable automated method development and data analysis, which leads to consistent and accurate results.
Advanced Detectors
With the development of advanced detectors, the sensitivity and selectivity of HPLC analysis has improved. Novel detectors (charged aerosel detectors (CAD) for example) have enabled the accurate detection of non-absorbing and low-absorbing molecules which have been challening to analyze for years using traditional UV/Vis detectors. Mass spectrometry detectors combined with HPLC offer high sensitivity, specificity, and increased identification capabilities for complex biomolecules.
Implementation of Quality by Design (QbD)
Quality by Design (QbD), is a commonly used systematic approach to biopharmaceutical develoment that emphasizes the understanding of product and process parameters to maintain consistent results. With the integration of QbD principles in to the HPLC calibration and method development has led to higher quality experiments and method robustness. By incorporating QbD, biopharmaceutical and medical related organizations can identify critical process parameters and optimize HPLC methods, which has resulted in reduced regulatory scrutiny and ultimately, higher quality products.
Multidimensional HPLC
Multidimensional HPLC, aka, "2D-HPLC", is a powerful technique that combines 2 or more columns with different separation mechanisms to improve the resolution and peak capacity of complex samples. This has proven particularly beneficial for the analysis of biopharmaceuticals because it enables the separation of structurally similar biomolecules that may co-elute in a single dimension. The 2D-HPLC has led to better quantifications and identifications of critical quality attributes for biopharmaceuticals.
About GL Technologies
GL Technologies(formally Calibration Consultants) is a full service calibration provider specializing in the Biopharmaceutical and Medical Device industries. Our management has worked in, managed, and developed FDA cGMP fully compliant programs. Our services include roving crews for the Biopharmaceuticals for regular scheduled calibrations or shutdown and new system situations.