Cell culture media range from simple components to complex chemically defined mixtures. They may contain a number of chemical components, each with individual chemical properties — and any variation in which ingredients can affect cell culture processes and biological products being manufactured. Although simple substances can be identified easily using well-known classical methods such as Fourier-transform infrared spectroscopy (FTIR), analysis becomes more challenging when dealing with complex mixtures. Section VII-3-C of the Q7A guidance from the International Council for Harmonisation…

Biopharmaceutical manufacturing processes require that prepared raw materials and product intermediates be held at different stages. During hold times, however, process and product intermediates are susceptible to microbial risks from bioburden, endotoxins, and exotoxins. Such risks arise from multiple sources, including bioproduction facilities, equipment, operations, and raw materials. Even a prepared intermediate can help microbes to grow. The US Food and Drug Administration’s (FDA’s) guidance on Sterile Drug Products Produced By Aseptic Processing states that “the time limits established for…