You can demonstrate that your drug is structurally highly homologous to another using high-resolution 3D structure, determined by X-ray crystallography. Glycosylation can be analysed to determine the glycan structure and glycan quantitative ratio using sequential digestion with various exoglycosidases and HPLC, GC-MS, FAB-MS and DE-MALDITOF-MS and use HPAEC-PAD following digestion with trypsin and PNGase procedure to permits chromatographic comparison of oligosaccharide patterns in a qualitative and quantitative manner. After doing all this, you can say that your drug is highly similar to the other. You still can never know if your drug will provoke an immune reaction.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.