Biologics Analysis
Antifoam agents, divalent metal cation and EDTA impurities are often associated with the manufacturing and formulation process of biologics. Maxxam has developed a number of analytical procedures required for in-process monitoring as well as bulk and final product release testing. We specialize in validation of analytical methods involving many complex matrices associated with bio-pharmaceutical product development.
Maxxam has developed procedures for characterizing and quantifying the presence of leachable additives, such as calcium or zinc stearate and phthalates from plastic products in a variety of matrices used in the biotechnology industry.
To assist in identifying unwanted extractable components in leachates of plastic materials, a NIST traceable library is employed to simplify complex GC-MS spectra. While this technique is best-suited for the determination of volatile species, LC-MS can be used to analyze these leachates and characterize the non-volatile extractable components. For elemental impurities/ additives and characterization of plastic materials, the laboratory uses high-pressure microwave digestion, followed by conventional ICPMS analyses.
