Biotherapeutics development requires accurate and robust analytical testing methodologies with dependable separations. Agilent is committed to the biopharmaceutical market and has the initiative to leverage the entire product portfolio, application-specific total workflow solutions, and global presence to deliver the support customers rely on to make trusted decisions. As a trusted supplier of Agilent solutions in Africa, Chemetrix is proud to see customers thrive and advance in their research and development.
With biopharma continuing to grow, there are challenges that naturally arise as part of the sector’s evolution. Here, we explain how Agilent’s products address customer pain points including poor reproducibility and difficulties with instrumentation and methods, with insights from Padraig McDonnell, executive vice president and general manager for the Chemistries and Supplies Division at Agilent Technologies.
The future of biopharmaceuticals looks promising with life-changing treatments, and the field keeps growing, powered by innovative groundbreaking therapies to treat cancer and autoimmune diseases. Advancing these novel biotherapeutics safely in the clinic requires reliable manufacturing and quality control processes.
The complexity of biopharma development
The complex heterogeneous nature of biotherapeutics requires accurate and robust analytical testing methodologies with dependable chromatographic separations. Identifying critical quality attributes (i.e., impurities that could impact the product safety and efficacy) is the most difficult step in the implementation of a Quality by Design approach for biopharmaceutical development and production. Defining each product attribute is extremely challenging. Therefore, consistency of product quality becomes even more important.
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Some of the key challenges in biopharma development are accuracy, robustness, and reproducibility of the data. It all comes down to speed and efficiency of the workflow. It is important to recognise that several analytical techniques are used as part of a workflow solution. This includes sample preparation, separation detection, and data analysis. Each part of the workflow must work seamlessly with the other components to ensure trusted answers.
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Innovative solutions for quality challenges
Reproducibility is a cornerstone of scientific research, ensuring that results can be consistently replicated to validate findings and advance knowledge. Several factors contribute to this issue, including variability in biological samples, inconsistencies in experimental procedures, and limitations in analytical techniques. Known for their precision and sensitivity, Agilent’s mass spectrometry systems deliver highly reproducible results, essential for accurate biomolecule analysis.
Liquid chromatography is another critical technique in the biopharma and biotherapeutics industries, used extensively for the separation, identification, and quantification of complex biological samples. However, achieving consistent and reproducible results can be challenging due to the complexity and variability of these samples.
Agilent offers a wide range of high-performance LC columns tailored for different applications, ensuring optimal separation of complex biomolecules. These columns are designed to provide high resolution and reproducibility, crucial for accurate quantification.
The systems are equipped with highly sensitive detectors, such as UV, PDA, fluorescence, and mass spectrometry detectors. These detectors provide accurate quantification and detection of analytes at low concentrations, enhancing reproducibility.
Getting the workflow right
With great instruments comes great software. Agilent’s data analysis software integrates seamlessly with their instruments, offering powerful tools for data processing, visualisation, and interpretation. This integration helps ensure that data is accurately analysed and reproducible. These software solutions are designed to maintain data integrity and comply with regulatory standards, supporting reproducibility and reliability in research and development.
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Regular customer contact and integrating the voice of customer is really critical to us. It gives us exceptional insight into the scientific challenges our customers face. These insights enable Agilent to put an intentional focus on biopharma, as we continue to develop new products and services that help our customers. Collaboration and cross-functional teamwork have enabled us to deliver new products and workflow solutions that better address customer analytical needs.
The biopharma and biotherapeutics industries face significant challenges related to reproducibility and instrumentation. Chemetrix can assist labs in addressing these pain points with innovative products from Agilent Technologies and comprehensive support, enhancing reproducibility, simplifying instrument operation, and ensuring reliable results. By leveraging advanced analytical instruments solutions, biopharma and biotherapeutics professionals can overcome these challenges, accelerating their research and development efforts and ultimately contributing to the advancement of healthcare.
This article includes information and text originally published by Agilent Technologies
