Last week, we wrote a post on new analytical methods for the detection of impurities that our R&D group had developed for the drug Febuxostat. And we’ve done the same in other posts, as well (see, for example, this post on Genotoxic Impurities). Drug quality and strong analytical capabilities obviously go hand-in-hand – it’s virtually impossible to achieve the former without the latter at all stages of a drug’s development and production. Staying on the cutting edge of analytical development – as Neuland has done with genotoxic impurities and drugs such as Febuxostat – is one of our strategies geared towards helping clients build successful drug portfolios. Companies want highly-competent research and manufacturing partners. An in-depth evaluation of analytical capabilities is critical to the selection a pharma contract research & manufacturing firm. In our experience working with APIs, peptides, and contract manufacturing as a whole, we’ve found that clients generally seek:
- Overall method development and validation expertise with different techniques used for the estimation of impurities Companies want rugged and robust methods developed…something we see frequently with complex chiral molecules, high molecular weight molecules and peptides. In many cases, this will involve the use of technologies such as HPLC, GC, Chiral HPLC, HPLC-ELSD, or HPLC-RI.
- Residual metals quantification in drugs Metal particle contamination during drug manufacture is a common problem, and – notably with drugs that treat chronic diseases, are used long-term or are used frequently – repeated exposure through injection can lead to metal poisoning. Aware of the risks, pharma companies often require suppliers or manufacturers to have established, proven methods for the quantification of residual metals present in drugs or the drug’s components. The presence of metal contaminants is typically determined to ppm levels using Inductively-Coupled Plasma Mass Spectrometry(ICP-MS). In some cases, other steps may be required. For example, compounds which are not in aqueous solution may demand additional steps, such as high-recovery micro digestion.
- Genotoxic impurity evolution and quantification Increasing awareness of the risks of genotoxic impurities has led to the development of rigorous testing standards. (Neuland is actively involved in method development and research in this field). Sensitive methods development that can detect and quantify impurities to the level of Toxicological threshold concern (TTC, 1.5 microgram/gram or 1.5 ppm) utilize iterations of LC-MS and GC-MS.
- Comprehensive analytical technologies Identifying and characterizing both impurities and drug substances often requires multiple approaches. Contract manufacturing analytical capabilities can include:
- Mass spectroscopy (LC-MS and GC-MS)
- Infrared spectroscopy (IR)
- Nuclear magnetic resonance spectroscopy (NMR)
- Differential scanning calorimeter(DSC)
- X-Ray Diffraction(XRD)
- Differential scanning calorimeter (DSC)
- Infrared spectroscopy (IR)
- Thermal gravimetric analysis (TGA)
- Particle size distribution (PSD) analyzer
Technology Matters – and so does Process At Neuland, it’s important for us to stay on the leading edge of analytical technology. Changes are happening rapidly, and capabilities are constantly being extended. As a drug contract manufacturer, however, processes are just as important, in fact – they are often the most important thing. Methods – and the technologies that enable them – are only as useful as the processes that can be developed, reproduced, documented and implemented with them. How much do analytical capabilities weigh in your Company’s selection of a contract manufacturer?