Special Issues
This article reviews the development of FDA's PAT Initiative along with CPAC's ANSI/ISA-76.00.02 (2002) (NeSSI) development. The intent is to show how the NeSSI components could contribute to the PAT philosophy and physical requirements.
Synthesizing Synthetic Oligonucleotides: An Interview with the CEO of Oligo Factory
February 6th 2024LCGC and Spectroscopy Editor Patrick Lavery spoke with Oligo Factory CEO Chris Boggess about the company’s recently attained compliance with Good Manufacturing Practice (GMP) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Expert Working Group (Q7) guidance and its distinction from Research Use Only (RUO) and International Organization for Standardization (ISO) 13485 designations.