Peptide and oligonucleotide therapeutics: A chromatographers viewpoint
Those involved in peptide and oligonucleotide therapeutics exist in a unique position in the pharmaceutical industry that are probably not fully appreciated by their colleagues developing either small molecule or protein therapeutics. The molecular entities that peptide and oligonucleotide chemists have under development are typically biopolymers similar to natural molecules like proteins therapeutics, but they are chemically synthesized making their production and manufacturing challenges more akin to traditional small molecule therapeutics. From a regulatory point of view peptide and oligonucleotide companies are burdened by CMC requirements of both chemical and biologic candidates; comprehensive analytical methods for evaluating manufacturing controls, toxicology, stability and immunogenicity are all required for these molecules more so than other classes of therapeutics.
While both peptides and oligonucleotides are similar in that they are chemically synthesized in a solid phase chain extension reaction; for peptides FMOC amino acids are stepwise added to create a growing chain, in ...