Special Feature from the annual Drug Development & Delivery report: Analytical Testing Trends in 2022
“Salubrent Pharma Solutions is a recently formed CDMO focused on supporting the shift toward biologics and personalized medicines, where small batch fill and finish services, combined with continuous batch-fed API processes and just-in-time/direct-to-patient delivery, will ensure patients are never without the life-saving therapies they require,” says Anand Padmanabhan, Director of Analytical Development at Salubrent. “To this end, Salubrent has built its analytical services lab to meet the needs of this changing paradigm.”
In addition to its broader offering of small-molecule analytical testing methods, Salubrent has assembled a team of scientists, and specific instrumentation, focused on large-molecule analytical method development. One specific challenge developing these therapies is the identification of impurities in drug substances and finished goods. Mr. Padmanabhan views gas chromatography (GC) as a vital analytical technique in this effort because of its ability to separate the organic volatile compounds of a sample mixture (typically drug substances) and detect them, thus determining their presence or absence and/or how much is present. “GC is also helpful in the determination of potency, dissolution rate, cleaning verification, etc. in instances where compounds cannot be detected using HPLC UV,” he adds.
Analysis for actives that do not have a UV chromophore cannot be detected using HPLC alone. “In this area, GC is a useful tool, and by adding mass spectrometry (MS), this instrument becomes even more powerful in the identification of impurities,” according to Mr. Padmanabhan. “Overall, a compound is identified via GC-MS not only by comparing its retention time to a standard (GC), but also by using its mass spectrum, making GC in combination with MS an extremely powerful analytical tool.”
GC/MS analysis has endless applications in material testing, identification, and certification. Identification of organic volatile impurities is one of the main applications. In the pharmaceutical industry, GC/MS is used in research and development, production, and quality control. In medicinal chemistry, GC/MS is used in the synthesis and characterization of compounds and in pharmaceutical biotechnology.
“Salubrent has the GCHS and GC/MS instruments analysis capabilities and expertise necessary to handle these types of complex projects,” says Mr. Padmanabhan, adding that he views Salubrent’s ELISA testing, Malvern Mastersizer particle size analysis, and HPLC with PDA impurity and assay potency quantitation capabilities as key to supporting the industry’s increasing focus on biologics and personalized therapies.