The Importance of Liquid Chromatography to the Pharmaceutical Industry
Effective application of separation science contributes to a smarter, risk-based approach to pharmaceutical research and quality
Scott Hanton is the editorial director of Lab Manager. He spent 30 years as a research chemist, lab manager, and business leader at Air Products and Intertek. He earned...
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Liquid chromatography (LC) is a vital workhorse analytical instrument for the pharmaceutical industry at every stage of the drug discovery process. Modern ultrahigh pressure liquid chromatography (UPLC) is the key technology to separate, identify, and quantify drug components and metabolites. UPLC instruments have enabled high-resolution separations to be completed in minutes, greatly expanding the role for LC in complex research and in quality assurance and quality control applications.
LC provides important safety, quality, and risk management data throughout the drug development process. Chromatography and separations help to identify the key compounds to explore and enable greater purity during scale up, especially a biopharmaceutical product that is produced through a biological process, rather than a chemical synthesis.
“From any scale that you can think of in the research and discovery stage, through development to manufacturing and quality control, LC is ubiquitous,” according to Robert Buco, director of global product management, LC systems, at Waters Corp. It is the key technology that follows the journey of a molecule from the time it is recognized as a potential active pharmaceutical ingredient, through product development, manufacturing, packaging, and delivery to patients.
New pharmaceutical products play an integral role in enhancing human health. These formulations must be precise and the components must be pure. Accidents in composition or unexpected contamination can have significant impacts on patient health. LC technology provides the high-quality data required to reduce the risk of harm to patients. With their speed, accuracy, and reliability, LC methods deliver unparalleled capability to analyze the many components of a drug product for purity and to ensure the proper concentrations in the final product. “One of the most critical roles of is ensuring that the quality and safety of the products that are packaged and provided to the world are what is desired; that the drugs contain what is claimed, and don't have any impurities that would detract from their safety or efficacy,” Buco adds.
The breadth and depth of data available from modern LC instruments is enabling a smarter, risk-based approach to pharmaceutical research and quality. The accuracy, precision, and speed of these instruments delivers the data required for a quality by design approach. Having robust processes for instrument and method validation, clear preventive maintenance protocols, and effective informatics to chart data and trends all reduce the risk of integration and migration, helping scientists meet their product safety requirements.
LC instruments deliver quality data, speed, and accuracy for pharma labs
LC technology continues to develop rapidly with important innovations that impact the discovery of new drug candidates, the selection of new drugs to develop, and ensure the safety and quality of new medicines as they become available on the market.
LC innovations contribute to the high-throughput world of pharmaceutical research and manufacturing. The instruments combine well with the latest in liquid handling automation and sample preparation augmented by robotic automation stations.
Once the chromatograph completes the separation of the components, LC is aided by significant innovation in the powerful detectors combined in these instruments. New, more powerful high-resolution mass spectrometers and more sensitive fluorescence detectors provide for hyphenated solutions that deliver the required specificity, sensitivity, and speed required during drug discovery and development.
Current research in LC technology is helping to expand the range of materials accessible to these analyses. The use of different wetted surface materials, coatings, and treatments are enabling more hydrophobic and sticky materials to be analyzed with high accuracy and confidence. This is enabling greater understanding of materials like biomarkers, lipids, and chelating peptides and driving new biopharma solutions toward innovative products.
The increasing power of modern LC instruments also brings complexity, in both how the experiments are executed and the details available from the data. LC-MS experiments can generate gigabytes of data that can be critical to solve problems related to chemical structures and purity of components. Innovations in chromatography data systems and lab informatics enable detailed control of the instruments, reproducible experiments, and rapid sharing of meaningful lab results.
Taking proper care of LCs ensures long-term reliability
The demand on LC instruments from research to manufacturing is intense. Customers expect that these important instruments are consistently available, meet the methods’ instrument suitability requirements, and are robust to handle the challenges of these analyses to enable pharmaceutical companies to address any risks in the production of medicines. With appropriate preventive maintenance and effective service options, these modern LC instruments are designed to deliver long-term service to the lab. To keep the instruments operating properly, it is important to build a solid relationship with a trusted service provider, and budget the time and money required to protect these important assets.
Carefully charting the performance of LC assets will enable lab managers to know when they can no longer be consistent and robust data providers. LC technology continues to advance and provide new benefits to the lab. It is important to set criteria that will help determine when instruments need to be replaced to ensure reliable data, sufficient uptime, reduced re-work, and access to innovative features.
LC technologies play a key role in enabling high quality, ensuring safety, and minimizing risk in the drug discovery and manufacturing processes. Ongoing innovation will keep LC delivering these key roles as the needs of the pharmaceutical industry evolve to assure the safety and efficacy of new drugs and improvements in ways to treat patients.