Pharmaceutica Analytica Acta

Hideharu Shintani

Publications

• Short Communication
  Development of Test Method for Pharmaceutical and BioPharmaceutical Products
  Author(s): Hideharu ShintaniHideharu Shintani
  
  Biological products are mostly macromolecular entities that are considerably larger than most chemical products. With the exception of synthetic oligonucleotides or peptides, living cells-complex metabolic factories produce them. The target molecule(s) must be isolated from a biochemical milieu consisting of chemical entities relatively similar to the desired product. As such, it may be difficult to completely eliminate impurities derived from the host system. The purified target may comprise several structurally heterogeneous forms, some or all of which might be active. Compared to traditional chemical drugs, biological materials are highly labile, and unable to tolerate high temperatures or undue chemical or physical stress. Higher-order biological products (e.g., cells and tissues) may have a very short window of viability. It requires numerous complex analytical methods to pro.. View More»
  DOI: 10.4172/2153-2435.1000258

  Abstract PDF