Biotech Pharmaceutical Regulation

Top CMC Pitfalls in Biologics IND Application and How to Avoid Them

Filing an Investigational New Drug (IND) application for a biologic—be it a monoclonal antibody, recombinant protein, or vaccine—is a high-stakes milestone. While the Chemistry, Manufacturing, and Controls (CMC) section is critical, many applications face delays due...
Chemical Instrument PopSci

 Why C18 Column is the Gold Standard of HPLC

If you’ve ever stepped into an analytical lab, you’ve likely seen a C18 column. Often called the “workhorse” of the laboratory, this single piece of technology handles nearly 80% of all high-performance liquid chromatography (HPLC) separations. I...