Adopting an innovative approach to analytical chemistry can help drive efficiencies and reduce critical timelines in successfully delivering vital medicines to patients.
Fremont, CA: While contract development and manufacturing organizations (CDMOs) can support pharmaceutical companies with their analytical requirements for both small and large-scale projects, the opportunity exists to increase the market speed with innovative thinking. Here the following explores the importance of innovation during analytical chemistry and evaluates how time to market can be reduced during the analytical testing stage. Also, the value of understanding the drug development and manufacturing process during analytical testing is reviewed.
The analytical services market
A higher preference from drug developers to redirect their resources to focus on core capabilities is giving rise to the growth in the outsourced analytical services market. The time pressures and in-house capacity issues have led many organizations to turn to stand-alone service providers and CDMOs to help them build a more strategic approach to their analyses and testing processes. Simultaneously, stricter demands from regulatory agencies for more analytical details on medicines and process development also drive the need for better and more efficient analytical strategies.
Innovative approaches to analytical chemistry
CDMOs strive to continuously search for innovative solutions that can bring high value to its customers. With more systematic approaches being introduced, automation of analytical instrumentation is becoming simple. As a result, the volume of data crafted increases. Simultaneously, the level of resources needed to generate this data is decreasing, which has substantial benefits for the companies considering the ever-evolving market demand.
The development of quality products is possible only with a forward-thinking, innovative mindset and detailed monitoring of the emerging technological advancements. Traditionally, analyses have been used to quantify the active ingredient and the impurities. Innovation has now led to the ability to estimate unexpected additions in formulations, such as elemental impurities generated due to manufacturing vessels, reactants, etc.
Earlier, elemental impurities were determined using classical analysis, like heavy metals tests and limits of arsenic. That is now being phased out, favoring more modern analytical techniques, including Raman spectroscopy, optical emission spectroscopy (OES), inductively coupled plasma mass spectrometry (ICP-MS), ultra-performance liquid chromatography (UPLC), and nuclear magnetic resonance (NMR) spectroscopy. Leveraging various detectors, such as a refractive index detector, a fluorescence detector, an evaporative light scattering detector (ELSD), and Quadrupole Dalton (QDa) detectors during method development, allows companies to ensure product safety and efficacy. This allows for providing substantial data for regulatory authorities. Furthermore, orthogonal analytical techniques provide a fuller understanding of the product composition, in terms of compliance, both Q1 and Q2. The utilization of these techniques helps reduce timelines and, in turn, allows medicines to be delivered to the market more quickly.