Moving a lipid- or polymer-based nanoparticle formulation from lab scale to GMP manufacturing is a complex process. Tech transfer is a critical stage where many projects face delays, increased costs, or regulatory hurdles due to missing or unclear steps. Careful preparation before engaging a Contract Development and Manufacturing Organization (CDMO) is essential to avoid these pitfalls. By approaching the transfer methodically, you can significantly reduce risk and ensure you

Most mRNA programs begin the same way. A coding sequence or gene of interest is selected. A codon optimization tool is run. The GC content looks acceptable. The sequence is ordered. Then expression is lower than expected, stability is inconsistent, innate immune activation appears, and manufacturing yields are unpredictable. The assumption was simple: optimize codon frequency and translation will improve. Reality is more complex. Codon optimization is only one variable in a m

This article compares turbulent mixers (solvent injection) and extrusion methods, highlighting their advantages, limitations, and practical applications to help you decide which method suits your needs best.